HOLDING STRONG!
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
So Elite's generic Norco approval could come any day now!!!!!!!!
We could see news for methadone launch or Norco approval SOON!!!!!!!!
I think we are still a month away from Elite's generic Percocet launch but then again Elite could surprise us with a major marketing agreement for the generic percocet at any time also.
Status of Elite's 6 submittals as reported in Elite's 2018 10 K.
FDA GOAL IS TO PROCESS SUBMITTALS IN 10 MONTHS!!!!
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
APPROVED!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Status of Elite's 6 submittals to FDA from the 2018 10 K.
FDA GOAL IS TO PROCESS SUBMITTALS IN 10 MONTHS!!!!
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
APPROVED!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Billions $$ in market potential coming to ELITE PHARMA IN less than a year!!!!!!!!
JUST 1% for the 2 approved puts ELITE at $5.3 MILLION, 5% = $26.5 MILLION. Revenue IS COMING!!!!!!!!
Approved - generic version of Percocet - QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.
APPROVED! - generic version of a synthetic narcotic analgesic - Based on QuintilesIMS Health data, the annual retail sales for the brand and generic products were approximately $30 million.
AND MORE APPROVALS COMING!!!!!!!!
SOON! - generic version of Norco - $700 million according to IMS Health data.
SOON! - generic version of OxyContin - IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
December 2018 (10 months) to Early 2019 - Elite/SunGen - generic version of an immediate release central nervous system (“CNS”) stimulant - IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017.
March 2019 (10 months) - Elite/SunGen - generic version of an extended release CNS stimulant - total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017.
$500 million + $700 Million + $30 million + $2.3 BILLION + $400 million + $1.6 BILLION = $5.44 BILLION market opening up to Elite (ELTP).
stock....boy, if you did see that then it was a time when was experiencing a bit of learning curve with the FDA. IT IS OBVIOUS that that curve is NOW turning UP!!!!!!!!
2 APPROVALS within a month, MORE APPROVALS COMING!!!!!!!!
1 Marketing plan or agreement coming for Generic Percocet with SALES/REVENUE coming soon!
1 marketing agreement in place for Generic Methadone Hydrochloride with Glenmark Pharmaceuticals, Inc. with REVENUE coming soon!
ELITE IS BECOMING SUCCESSFUL!!!!!!!!
ELITE WILL MAKE $$,$$$,$$$!!!!!!!!
SEE THE MATH - Billions $$ in market potential in less than a year possible for ELITE PHARMA!!!!!!!!
JUST 1% for the 2 approved puts ELITE at $5.3 MILLION, 5% = $26.5 MILLION. Revenue IS COMING!!!!!!!!
Approved - generic version of Percocet - QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.
APPROVED! - generic version of a synthetic narcotic analgesic - Based on QuintilesIMS Health data, the annual retail sales for the brand and generic products were approximately $30 million.
SOON! - generic version of Norco - $700 million according to IMS Health data.
SOON! - generic version of OxyContin - IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
December 2018 (10 months) to Early 2019 - Elite/SunGen - generic version of an immediate release central nervous system (“CNS”) stimulant - IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017.
March 2019 (10 months) - Elite/SunGen - generic version of an extended release CNS stimulant - total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017.
$500 million + $700 Million + $30 million + $2.3 BILLION + $400 million + $1.6 BILLION = $5.44 BILLION market opening up to Elite (ELTP).
Status of Elite's 6 submittals to FDA from the 2018 10 K.
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
APPROVED!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Barchart opinion for Mon, Aug 6th, 2018 for ELTP Elite Pharma Inc
100% Buy
Overall Average Signal calculated from all 13 indicators. Signal Strength is a long-term measurement of the historical strength of the Signal, while Signal Direction is a short-term (3-Day) measurement of the movement of the Signal.
ELTP news release is usually issued within the 2 weeks prior to quarterly CC.
We should see something this week or first of next week.
Elite's $Billions in market access potential in less than a year!
Approved - generic version of Percocet - QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.
SOON! - generic version of Norco - $700 million according to IMS Health data.
SOON! - generic version of a synthetic narcotic analgesic - over $40 million in 2016 according to IMS Health data.
SOON! - generic version of OxyContin - IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
December 2018 (10 months) to Early 2019 - Elite/SunGen - generic version of an immediate release central nervous system (“CNS”) stimulant - IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017.
March 2019 (10 months) - Elite/SunGen - generic version of an extended release CNS stimulant - total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017.
$500 million + $700 Million + $40 million + $2.3 BILLION + $400 million + $1.6 BILLION = $5.54 BILLION market opening up to Elite (ELTP).
Status of Elite's 6 submittals to FDA from the 2018 10 K.
DECEMBER 2018 AND THE OTHER IN MARCH 2019
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
SEE THE MATH - Billions $$ in market potential in less than a year possible!!!!!!!!
Approved - generic version of Percocet - QuintilesIMS Health data for the twelve months ending May 31, 2018, the retail sales for the brand and generic products were approximately $500 million.
SOON! - generic version of Norco - $700 million according to IMS Health data.
SOON! - generic version of a synthetic narcotic analgesic - over $40 million in 2016 according to IMS Health data.
SOON! - generic version of OxyContin - IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
December 2018 (10 months) to Early 2019 - Elite/SunGen - generic version of an immediate release central nervous system (“CNS”) stimulant - IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017.
March 2019 (10 months) - Elite/SunGen - generic version of an extended release CNS stimulant - total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017.
$500 million + $700 Million + $40 million + $2.3 BILLION + $400 million + $1.6 BILLION = $5.54 BILLION market opening up to Elite (ELTP).
Yes! Norco has been replied to by Elite. The FDA requested additional information relating to this filing, which was provided.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
$5.5 BILLION market access for ELTP in less than a year!
APPROVALS for generic version of Norco and generic version of a synthetic narcotic analgesic should come at any time now! Elite is still working on the response to FDA for Oxycodone Hydrochloride ER so it's approval could come last of this year or early 2019. The approvals for the SUNGEN partnership products should be one in December 2018 and the other in March 2019. So by March 2019 ELITE Pharma could have approved drugs with market numbers of over $$ 5.5 BILLION $$ so with even a 1% market penetration ELITE Pharma could have revenue of over $55,000,000 and that does not even include the potential for SequestOX approval!
Elite's 6 submittals to FDA with Elite's status statement from the 2018 10 K.
DECEMBER 2018 AND THE OTHER IN MARCH 2019
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Approval of Generic Percocet Tablets gets ELITE into a market total U.S. sales of approximately $500 million using twelve months ending May 31, 2018 numbers!
If ELITE get X% of that market you get $$$$$$$$
1% = $5,000,000
2% = $10,000,000
5% = $25,000,000
10% = $50,000,000
15% = $75,000,000
20% = $100,000,000
You get the picture! So it is not a question of will ELITE's revenue increase - it is a question of HOW MUCH WILL ELITE'S REVENUE INCREASE?
namtae - Skilled, balanced, honest people in the markets today, lol, that is hard to find in almost any company trading!
namtae, ELITE is making money now!
They use it to do research and submit NDAs and ANDAs.
READ the 8Ks and 10Ks. The key is that those reports will grow revenue and income to the $millions, 10s of $millions, and maybe even in the not to distant future 100s of $millions!
In less than a year $5.5 BILLION market available to ELITE (ELTP)
RESEARCH IT! With just the Tuesday approval and the 5 ANDAs in line for additional approvals ELITE has a great future!
1% market penetration for ELITE Pharma give the potential revenue of over $55,000,000 which does not even include the potential for SequestOX approval!
namtae, MORE REVENUE! Even at 1% or any amount in revenue it is still more money than today! There is no problem with ELITE making more money!!!!!!!!
Here is some of the history of ELITE's ANDA submittals and where they are now.
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
APPROVALS for generic version of Norco and generic version of a synthetic narcotic analgesic should come at any time now! Elite is still working on the response to FDA for Oxycodone Hydrochloride ER so it's approval could come last of this year or early 2019. The approvals for the SUNGEN partnership products should be one in December 2018 and the other in March 2019. So by March 2019 ELITE Pharma could have approved drugs with market numbers of over $$ 5.5 BILLION $$ so with even a 1% market penetration ELITE Pharma could have revenue of over $55,000,000 and that does not even include the potential for SequestOX approval!
ELTP's share of Generic Percocet Tablets market
Total U.S. sales $500 million using twelve months ending May 31, 2018 numbers!
ELITE get X% of that market you get $$$$$$$$
1% = $5,000,000
2% = $10,000,000
5% = $25,000,000
10% = $50,000,000
15% = $75,000,000
20% = $100,000,000
See below, Elite's 6 submittals to FDA with Elite's status statement from the 2018 10 K. Base on the below information APPROVALS for generic version of Norco and generic version of a synthetic narcotic analgesic should come at any time now! Elite is still working on the response to FDA for Oxycodone Hydrochloride ER so it's approval could come last of this year or early 2019. The approvals for the SUNGEN partnership products should be one in December 2018 and the other in March 2019. So by March 2019 ELITE Pharma could have approved drugs with market numbers of over $$ 5.5 BILLION $$ so with even a 1% market penetration ELITE Pharma could have revenue of over $55,000,000 and that does not even include the potential for SequestOX approval!!!!!!!!
DECEMBER 2018 AND THE OTHER IN MARCH 2019
APPROVED!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
FROM JUNE 2018 10K
Oxycodone hydrochloride and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016, the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII) 5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve moderate to severe pain. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
FROM JUNE 2018 10K
Hydrocodone bitartrate and acetaminophen tablets USP CII (generic version of Norco®)
On December 12, 2016, the Company filed an ANDA with the FDA for a generic version of Norco® (hydrocodone bitartrate and acetaminophen tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data. The FDA requested additional information relating to this filing, which was provided. The Company awaits the FDA’s response.
COMING SOON ALSO!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
FROM JUNE 2018 10K
Generic version of a synthetic narcotic analgesic
On April 4, 2017, the Company filed an ANDA with the FDA for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents have annual sales in excess of $30 million according to IMS Health Data. The Company expects a response from the FDA relating to this ANDA during the third quarter of the calendar year ended December 31, 2018. This product is an identified product in the Strategic Marketing Alliance between the Company and Glenmark Pharmaceuticals Inc USA (“Glenmark”) dated May 29, 2018, pursuant to which, subsequent to ANDA approval by the FDA, it will be manufactured by Elite and marketed/distributed by Glenmark. Please see the section below titled “Strategic Marketing Alliance with Glenmark Pharmaceuticals, Inc. USA” for further details.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
FROM JUNE 2018 10K
Oxycodone Hydrochloride extended release (generic version of Oxycontin®)
On September 20, 2017, the Company filed an ANDA with the FDA for generic version of Oxycontin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016. The FDA requested additional information relating to this filing. The Company’s response to the FDA’s request is in progress.
FROM JUNE 2018 10K - THESE ARE THE 2 SUBMITTED THIS YEAR SO FOR FDA 10 MONTH APPROVAL CYCLE WE ARE LOOKING AT ONE APPROVED IN DECEMBER 2018 AND THE OTHER IN MARCH 2019 - THESE 2 ARE IN THE 2 BILLION (AGAIN, THAT IS TWO BILLION) DOLLAR MARKET!!!!!!!!
Generic version of immediate release Central Nervous System stimulant
On February 8, 2018, the Company filed an ANDA with the FDA for a generic version of an immediate release central nervous system (“CNS”) stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma LLC (“SunGen”) under the Development and License Agreement between SunGen and the Company dated August 24, 2016 (the “SunGen Agreement”). According to IMS Health data, the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Generic version of extended release Central Nervous System stimulant
On May 24, 2018, the Company filed an ANDA with the FDA for a generic version of an extended release CNS stimulant. The
ANDA represents the second filing for a product co-developed with SunGen under the SunGen Agreement. According to IMS Health data, the branded product and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ended September 30, 2017. The Company has not yet received a response from the FDA on this filing.
Under the terms of the SunGen Agreement, the product will be owned jointly by the Company and SunGen. Elite shall have exclusive rights to market and sell the product under its own label. Elite will also manufacture and package the product on a cost-plus basis.
Only 9 competitors for oxycodone hydrochloride and acetaminophen according to the FDA list. That is for the specific oxycodone hydrochloride and acetaminophen tablets.
So, with the right pricing and Glenmark selling ELITE's FDA APPROVED - GET THAT - FDA APPROVED product ELITE will increase revenue substantially!!!!!!!!
Lets look at THE $$$$$$$$
Today's approval of Generic Percocet Tablets get ELITE into a market total U.S. sales of approximately $700 million from 2015 numbers!
If ELITE get X% of that market you get $$$$$$$$
1% = $7,000,000
2% = $14,000,000
5% = $35,000,000
10% = $70,000,000
15% = $105,000,000
20% = $140,000,000
You get the picture! So it is not a question of will ELITE's revenue increase - it is a question of HOW MUCH WILL ELITE'S REVENUE INCREASE?
APPROVED TODAY!!!!!!!! Submitted Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
COMING SOON!!!!!!!!
ALREADY PAST FDA'S GOAL OF 10 MONTHS SO THIS ONE COULD HIT SOON ALSO! Submitted Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
COMING SOON ALSO!!!!!!!! Submitted April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
COMING SOON ALSO!!!!!!!! Submitted Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
4 ANDA approvals could be announced at any time soon. FDA goal is 10 months. Elite has 4 already within that timeframe! FDA laughable questions have create delays with some but that time delay is short or past due so approvals can hit at any time!
Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
List below, ANDA approvals are coming!
Aug. 10, 2016 - Elite Pharmaceuticals files ANDA to Market Generic Percocet
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Percocet (oxycodone hydrochloride and acetaminophen, USP CII) 5 mg, 7.5 mg and 10 mg tablets with 325 mg of acetaminophen. Percocet is a combination medication and is used to help relieve moderate to severe pain.
Percocet and its generic equivalents had total US sales of approximately $700 million in 2015, according to IMS Health data.
Dec. 12, 2016 - Elite Pharmaceuticals Files ANDA for Hydrocodone and Acetaminophen Combo
Elite Pharmaceuticals, Inc. today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets, USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco is a combination medication and is used to help relieve moderate to moderately severe pain. The combination products of hydrocodone and acetaminophen have total annual US sales of approximately $700 million according to IMS Health data.
April 04, 2017 - Elite Pharmaceuticals Files ANDA for Pain Product
Elite Pharmaceuticals, Inc. today announced that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of a synthetic narcotic analgesic indicated for the management of pain. The branded product and its equivalents had annual sales of over $40 million in 2016 according to IMS Health data.
Sept. 20, 2017 - Elite Pharmaceuticals Files ANDA for Oxycodone Hydrochloride Extended Release
Elite Pharmaceuticals, Inc. announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.
Feb. 08, 2018 - Elite Pharmaceuticals and SunGen Pharma File ANDA
Elite Pharmaceuticals, Inc. a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant. The ANDA represents the first filing for a product co-developed with SunGen Pharma, LLC ("SunGen") under the Development and License Agreement ("Agreement"). According to IMS Health data the branded product and its equivalents had total U.S. sales of more than $400 million for the twelve months ending September 30, 2017.
May 30, 2018 - Elite Pharmaceuticals and SunGen Pharma File ANDA for Extended-Release CNS Stimulant
Elite Pharmaceuticals, Inc. a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of an extended-release CNS stimulant. The ANDA represents the filing of a second product co-developed with SunGen Pharma, LLC ("SunGen"). In February Elite and SunGen filed an ANDA to a generic version of an immediate-release CNS stimulant. According to QuintilesIMS Health data the branded product for the extended-release CNS stimulant and its equivalents had total U.S. sales of approximately $1.6 billion for the twelve months ending September 30, 2017.
Another one of interest from 2015
Could be a smart path for ELTP
Sales of ADHD Meds Are Skyrocketing. Here’s Why.
Feb. 24, 2015
Attention deficit hyperactive disorder is big business. That’s the conclusion of a new report, published by the market research firm IBISWorld, which showed that ADHD medication sales have grown 8 percent each year since 2010 and will grow another 13 percent this year to $12.9 billion. Furthermore, it projects this growth will continue over the next five years at an annualized rate of 6 percent, and take in $17.5 billion in the year 2020—making it one of the top psychopharmaceutical categories on the market.
Old article but ELTP could be a buyout candidate based on big pharma's way of thinking....
Oct 22, 2012
The Molecule In Ritalin Keeps Generating Revenue
This morning, Pfizer announced that it will spend as much as $700 million (including future milestone payments) to buy NextWave Pharmaceuticals, the maker of a long-acting liquid formulation of methylphenidate, the same drug that was in Ritalin, one of the first attention deficit/hyperactivity disorder (ADHD) drugs.
What's amazing is how much of the new value in the ADHD field has come from new formulations, not new molecules. That's true for Johnson & Johnson's Concerta (a long-acting methylphenidate pill) and Shire's Intuniv (a long acting version of another drug, guanfacine). And now Pfizer thinks there is value in yet another formulation. Concerns about how often stimulants should be used to help people concentrate aside, it's amazing that this market continues to support premium prices for what are essentially new formulations of generics.
mine/sharkey - yep, that is in INR not USD
sharkey, just some quick cut and post.
Hey, I am from Arkansas, I know a bunch of Billy Bobs, their manufacturing in not for prescriptions, LOL!
Glenmark Pharma Ltd
ticker - BSE pps $531
Total Assets - $11.763 billion
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules -- both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, Brazil.
Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.
Glenmark Pharmaceuticals Overview
Website us-glenmarkpharma.com
Headquarters - Mahwah, NJ
Size - 51 to 200 employees
Company - Private
Industry - Biotech & Pharmaceuticals
Revenue - $100 to $500 million (USD) per year
Often Elite Pharma will put out press NEWS release a week or two weeks before the report and conference call so we could a new ANDA or hopefully an approval prior to the conference call. Timing would be great if an approval came in prior to Financial Results for the Fiscal Year.
Gaming the price before Financial Results for the Fiscal Year report and conference call.
Seen it before. Drive pps down to try to make it look like something bad is coming the report.
Zoom Earth - also parking lot full
Employee parking FULL, just pulled up G satellite and it shows cars in the lot and around the street.