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We will see on Tuesday May 7, 2019 11:15 am to 11:30 am!
It cannot be hidden and it will happen!
CLINICAL TRIALS PLENARY SESSION
Tuesday May 7, 2019 11:00 AM - 11:15 AM
A Phase 3 Study of Isradipine as a Disease Modifying Agent in Patients with Early Parkinson’s disease (STEADY-PD III): Final Study Results
Tanya Simuni MD
Multiple PLENARY SESSIONS going on in different areas for the 2019 AAN
ANNUAL MEETING!
Go to the "SEARCH THE PROGRAM" tab and search "CLINICAL TRIALS PLENARY SESSION"
CLICK the link for CLINICAL TRIALS PLENARY SESSION and you with find -
11:00 AM - 11:15 AM
A Phase 3 Study of Isradipine as a Disease Modifying Agent in Patients with Early Parkinson’s disease (STEADY-PD III): Final Study Results
Tanya Simuni MD
This will be AWESOME for ELITE investor $$$$$$$$
Elite/SunGen 2 this Friday or maybe Monday!!!!!!!!
Elite/SunGen 1 CNS stimulant took 10 months which is inline with the FDA's goal for approvals.
With that being said.... Elite/SunGen 2 CNS stimulant was submitted on 24 May 2018 which would mean the FDA's goal would be approval by 24 MARCH 2019. Friday.... Monday.... sometime next week!!!!!!!!
This is a big one $$1,600,000,000 ($$ that is 1.6 BILLION) market opening up to ELITE Pharmaceuticals!!!!!!!!
$405 MILLION market available to Elite for current launched (includes Elite/SunGen 1 CNS - launch is imminent) drugs is NOT puny!!!!!!!!
Add in another $956 MILLION market for Elite's additional currently APPROVED drugs that they will be strategically entering the market with when it is effective for them is not puny!!!!!!!!
Add in $4.239 BILLION that is BILLION market for Elite's currently submitted and awaiting FDA approval (all those will be approved this year) which is not puny!!!!!!!!
Now add the resolution of SequestOX and you can add another $400 million!!!!!!!!
ELITE is turning into a pharma POWERHOUSE and their revenues will SKYROCKET!!!!!!!!
There is NO SEC FORM 144 reporting service!
Tried to find one but cannot find a subscription that allows general public access to these forms when filed.
So put up a link or screen shot proving you have factual evidence the form 144 has been filed.
puny drugs, lol, $405 MILLION market available to Elite for current launched (includes Elite/SunGen 1 CNS - launch is imminent) drugs is NOT puny!!!!!!!!
Add in another $956 MILLION market for Elite's additional currently APPROVED drugs that they will be strategically entering the market with when it is effective for them is not puny!!!!!!!!
Add in $4.239 BILLION that is BILLION market for Elite's currently submitted and awaiting FDA approval (all those will be approved this year) which is not puny!!!!!!!!
Now add the resolution of SequestOX and you can add another $400 million!!!!!!!!
ELITE is turning into a pharma POWERHOUSE and their revenues will SKYROCKET!!!!!!!!
Elite/SunGen 2 this Friday or maybe Monday!!!!!!!!
Elite/SunGen 1 CNS stimulant took 10 months which is inline with the FDA's goal for approvals.
With that being said.... Elite/SunGen 2 CNS stimulant was submitted on 24 May 2018 which would mean the FDA's goal would be approval by 24 MARCH 2019. Friday.... Monday.... sometime next week!!!!!!!!
This is a big one $$1,600,000,000 ($$ that is 1.6 BILLION) market opening up to ELITE Pharmaceuticals!!!!!!!!
Approval coming - Elite/SunGen 2 this Friday or maybe Monday!!!!!!!!
Elite/SunGen 1 CNS stimulant took 10 months which is inline with the FDA's goal for approvals.
With that being said.... Elite/SunGen 2 CNS stimulant was submitted on 24 May 2018 which would mean the FDA's goal would be approval by 24 MARCH 2019. Friday.... Monday.... sometime next week!!!!!!!!
This is a big one $$1,600,000,000 ($$ that is 1.6 BILLION) market opening up to ELITE Pharmaceuticals!!!!!!!!
aELmTPa, 25 March approval for Elite's generic Adderall XR!
You may be right with 29 March in consideration of the government shutdown but I was thinking the FDA was not impacted by it.
Approval SunGen 2 this Friday or maybe Monday!!!!!!!!
Elite/SunGen 1 CNS stimulant took 10 months which is inline with the FDA's goal for approvals.
With that being said.... Elite/SunGen 2 CNS stimulant was submitted on 24 May 2018 which would mean the FDA's goal would be approval by 24 MARCH 2019. Friday.... Monday.... sometime next week!!!!!!!!
This is a big one $$1,600,000,000 ($$ that is 1.6 BILLION) market opening up to ELITE Pharmaceuticals!!!!!!!!
Typical sell on news!
Traders selling for a 2 or 3 cent profit, lol.
Elite will began the next move higher after the flippers move out!
Isradipine results are already being speculated by the increase in demand.
All this talk about results delay is irrelevant - top line and final full results with just keep increasing the demand.
Any person at risk for PD with even a slight blood pressure concern are already talking to their doctors about Isradipine and already getting it prescribed. LOL, even a hint in March/May will increase the demand even more!!!!!!!!
NO! Seriously?? You really are reaching to far.
CEO had to be fully aware of the guidelines for pursuing Perc and Norco!
CEO saw an opportunity for income generating products and is pursuing a position in that market!
"jour_trader"
Are you saying the CEO pursued Perc & Narco and didn’t understand these guidelines?
Generic Perc/Norco launch is COMING! The DEA Quota process is not an over-night process. We will get an update during the CC. ELTP has to follow the DEA manufacturing quota request process and submission deadlines.
RESEARCH it and quit complaining about taking so long!
ANYONE with any intelligence understand that the ONLY thing that has been slowing ELTP is the FDA and DEA.
PATIENCE will bring great REWARD!!!!!!!!
Generic Perc/Norco launch update - DEA's quota process explained -
Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.
The Quota Process
Every year the United States sets Aggregate Production Quotas (APQ) for Schedule I, Schedule II, and Pseudoephedrine, Ephedrine, and Phenylpropanolamine (PPA) substances. The quota is based on the Controlled Substance Act (CSA) number. List I chemicals are also included because of the Combat Methamphetamine Epidemic Act (CMEA). All bulk active pharmaceutical ingredient (API) manufacturers that produce controlled drug substance API, manufacturers and packagers of Schedule I and II controlled substances, and manufacturers and importers of Pseudoephedrine, Ephedrine, and PPA must apply for quota. The request and approval/denial of quota can take six to eight weeks to process and bulk manufacture API can take six to nine months to process. This is important to consider when forecasting project timelines.
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
Manufacturers assigned to individual manufacturing quota may abandon their right to manufacture quota at any time by filing with written notice via DEA website.
The notice should include:
o Name of the controlled substance code number (CSA #)
o The amount chosen to be relinquished before the calendar year ends
The administrator may allocate the amount amended to the other manufacturers in proportion to their respective quotas. For the DEA, a registration is required to import and export controlled substances and controlled reference standards to and from abroad.
The approval process consists of eight steps that must be adhered to in order to file successfully. When partnering with a contract development and manufacturing organization (CDMO), it is important to select one that has vast knowledge and experience with filing controlled substance licenses with the DEA. Involve the DEA expert from the start to protect your product from delays and to fully understand the timelines needed for approval.
jour, only 20 manufacturers for perc and Elite is listed as one of them.
Check the FDA orange book and you can download a list of FDA approved applicant holders. There are a bunch that are DISCN (discontinued) and only 20 that are approved for RX.
Elite's generic Percocet and Norco slice of the pie??
Once Elite receives a quota from the DEA what could we expect?
For Percocet - would be up to around $23,800,000 increase in revenues if the slices are distributed equally.
For Norco - would be up to around $23,500,000 increase in revenues if the slices are distributed equally.
Even if slices are not equal Elite stands to benefit substantially in $$$$MILLIONS$$$$ of revenues!!!!!!!!
LOVE MATH - ELTP potential revenues!!!!!!!!
Current approved products (not all launched but approved and launch soon)!
Total $1.357 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $13,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $67,850,000 IN REVENUE!
This should be validated by the end of THIS YEAR!!!!!!!!
ADD in ELTP's soon to be approved generics for Oxy and Concentra! You get a total $5.657 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $56,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $282,850,000 IN REVENUE!
This should be validated by the in the next couple of years!!!!!!!!
Sure Sungen is partnered in for 2 of the 9 products and this does not include the 3 other Sungen partnered products that will have ANDA this year so you can add in another $1.964 BILLION for the future!
Lets take it out even further! Lets dream and say that ELTP gets all the products in the chart at the top Elite's page approved and launched!
Yes this even includes SEQUESTOX but not the other ADT products Elite has in development!
That is $8.066 BILLION $$$$$$$$
If ELTP can achieve 1% sales of these products it = $80,066,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $403,300,000 IN REVENUE$$$$$$$$
YES, I am LONG and can wait and watch this play out.
News in next few days! Elite usually has news prior to quarterly results and conference call.
News next week! Elite has a pattern of releasing news in the couple of weeks just prior to their quarterly report and conference call.
We will see something soon!
DEA's quota process explained -
Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.
The Quota Process
Every year the United States sets Aggregate Production Quotas (APQ) for Schedule I, Schedule II, and Pseudoephedrine, Ephedrine, and Phenylpropanolamine (PPA) substances. The quota is based on the Controlled Substance Act (CSA) number. List I chemicals are also included because of the Combat Methamphetamine Epidemic Act (CMEA). All bulk active pharmaceutical ingredient (API) manufacturers that produce controlled drug substance API, manufacturers and packagers of Schedule I and II controlled substances, and manufacturers and importers of Pseudoephedrine, Ephedrine, and PPA must apply for quota. The request and approval/denial of quota can take six to eight weeks to process and bulk manufacture API can take six to nine months to process. This is important to consider when forecasting project timelines.
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
Manufacturers assigned to individual manufacturing quota may abandon their right to manufacture quota at any time by filing with written notice via DEA website.
The notice should include:
o Name of the controlled substance code number (CSA #)
o The amount chosen to be relinquished before the calendar year ends
The administrator may allocate the amount amended to the other manufacturers in proportion to their respective quotas. For the DEA, a registration is required to import and export controlled substances and controlled reference standards to and from abroad.
The approval process consists of eight steps that must be adhered to in order to file successfully. When partnering with a contract development and manufacturing organization (CDMO), it is important to select one that has vast knowledge and experience with filing controlled substance licenses with the DEA. Involve the DEA expert from the start to protect your product from delays and to fully understand the timelines needed for approval.
So for Elite's generic percocet and norco - Their approval of ANDA came after the April 1st deadline to apply for the QUOTA year 2019. Can they apply ahead of the deadline and saying pending ANDA approval?? I do not know. ELITE WILL DEFINITELY GET THE DEA APPROVAL FOR THE NEXT YEAR which is almost a guaranteed slice of the Perc/Norco pie increasing revenue.
Maybe ELITE is waiting on the Oxy ANDA approval before applying to the DEA>
Elite is a listed as a manufacturer on the DEA's list but I cannot find much info on what they are approved to manufacture. So, I am sure ELITE is applying with the DEA to get the approvals to be a bulk manufacturer for Elites schedule I & II drugs.
Reference info-
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
The MATH again - ELTP major increase possible coming soon!!!!!!!!
Current approved products (not all launched but approved and launch soon)!
Total $1.357 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $13,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $67,850,000 IN REVENUE!
This should be validated by the end of THIS YEAR!!!!!!!!
ADD in ELTP's soon to be approved generics for Oxy and Concentra! You get a total $5.657 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $56,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $282,850,000 IN REVENUE!
This should be validated by the in the next couple of years!!!!!!!!
Sure Sungen is partnered in for 2 of the 9 products and this does not include the 3 other Sungen partnered products that will have ANDA this year so you can add in another $1.964 BILLION for the future!
Lets take it out even further! Lets dream and say that ELTP gets all the products in the chart at the top Elite's page approved and launched!
Yes this even includes SEQUESTOX but not the other ADT products Elite has in development!
That is $8.066 BILLION $$$$$$$$
If ELTP can achieve 1% sales of these products it = $80,066,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $403,300,000 IN REVENUE$$$$$$$$
YES, I am LONG and can wait and watch this play out.
Elite is a listed as a manufacturer on the DEA's list but I cannot find much info on what they are approved to manufacture. So, I am sure ELITE is applying with the DEA to get the approvals to be a bulk manufacturer for Elites schedule I & II drugs.
DEA's quota process explained -
Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances
Controlled drug substances are scheduled based on medical use in treatment, potential for abuse, and dependence caused if abused— the lower the control schedule the more potential for abuse. The process to obtain approval from the Drug Enforcement Administration (DEA) for Schedule I-V controlled substances and List I chemicals licensing involves intricacy and a detailed timeline of approvals. This article will discuss the background of controlled substance applications and how to successfully work with the DEA.
The Quota Process
Every year the United States sets Aggregate Production Quotas (APQ) for Schedule I, Schedule II, and Pseudoephedrine, Ephedrine, and Phenylpropanolamine (PPA) substances. The quota is based on the Controlled Substance Act (CSA) number. List I chemicals are also included because of the Combat Methamphetamine Epidemic Act (CMEA). All bulk active pharmaceutical ingredient (API) manufacturers that produce controlled drug substance API, manufacturers and packagers of Schedule I and II controlled substances, and manufacturers and importers of Pseudoephedrine, Ephedrine, and PPA must apply for quota. The request and approval/denial of quota can take six to eight weeks to process and bulk manufacture API can take six to nine months to process. This is important to consider when forecasting project timelines.
Quota requests have deadlines due for the next year’s forecast for manufacturing and packaging by April 1 of each year with DEA response by mid-December. Bulk API manufacturing quota requests should be made before May 1 of each year with the DEA response expected by mid-December as well. Keep in mind that the earlier the quota is requested the better. (Quota Applications, 2018)
Manufacturers assigned to individual manufacturing quota may abandon their right to manufacture quota at any time by filing with written notice via DEA website.
The notice should include:
o Name of the controlled substance code number (CSA #)
o The amount chosen to be relinquished before the calendar year ends
The administrator may allocate the amount amended to the other manufacturers in proportion to their respective quotas. For the DEA, a registration is required to import and export controlled substances and controlled reference standards to and from abroad.
The approval process consists of eight steps that must be adhered to in order to file successfully. When partnering with a contract development and manufacturing organization (CDMO), it is important to select one that has vast knowledge and experience with filing controlled substance licenses with the DEA. Involve the DEA expert from the start to protect your product from delays and to fully understand the timelines needed for approval.
ELTP MATH - $8.066 BILLION $$$$$$$$
Lets take it out even further! Lets dream and say that ELTP gets all the products in the chart at the top Elite's page approved and launched!
Yes this even includes SEQUESTOX but not the other ADT products Elite has in development!
If ELTP can achieve 1% sales of these products it = $80,066,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $403,300,000 IN REVENUE$$$$$$$$
YES, I am LONG and can wait and watch this play out.
Math - ELTP 100% to 4,000% PPS or more increase possible!!!!!!!!
Current approved products (not all launched but approved and launch soon)!
Total $1.357 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $13,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $67,850,000 IN REVENUE!
This should be validated by the end of THIS YEAR!!!!!!!!
ADD in ELTP's soon to be approved generics for Oxy and Concentra! You get a total $5.657 BILLION retail sales for these products!
If ELTP can achieve 1% sales of these products it = $56,570,000 IN REVENUE!
If ELTP can achieve 5% sales of these products it = $282,850,000 IN REVENUE!
This should be validated by the in the next couple of years!!!!!!!!
Sure Sungen is partnered in for 2 of the 9 products and this does not include the 3 other Sungen partnered products that will have ANDA this year so you can add in another $1.964 BILLION for the future!
I am LONG and can wait and watch this play out.
Trimipramine Maleate shortage.... FDA has this drug listed as in a shortage.
No large money made from shorting ELTP.
Except, maybe some years ago on the big run and would had to be a big fish or dark pool, not a retail trader.
BUT, what about shorting a stock as a business tactic????
Maybe there is a competitor trying to suppress ELTP stock to slow its grow and availability of funding or even to try to drive out of business.
Maybe a whistle blower could come forward and do the right thing by taking it to the news - that would be the news event of the markets - overnight celebrity for whoever breaks that story!!!!
So in searching I find -
High-frequency traders are front-running big orders made by mutual funds, hedge funds, ETFs, and any other large investor.
and
In Michael Lewis's "Flash Boys" - sub-penny pricing is a tool for HFT firms and market makers to front-run individual investors.
So ELTP is being played to find some large investor a saving or gain on orders.....
Thoughts????
0.083515 ? -0.004235 SERIOUSLY?? 0.xxxxx six decimal places. Got to be a computer algorithm controlling trading of ELTP.
ELTP could have been waiting on gen NORCO so they could work it with their gen Percocet. So, maybe they are selling both already since the label is out. Could be news at any time.
ELTP has launched methadone with Glenmark Pharma and it looks like isradipine is on with Glenmark as well.
Could see revenue up in Feb 2019 CC and MAJOR UP in revenue for JAN-MAR 2019!
ELTP partnering with Glenmark is excellent!
Glenmark Pharmaceuticals Inc. is part of Glenmark Pharmaceuticals Ltd. (GPL) which is a global innovative pharmaceutical company with operations in more than 50 countries.
INSPECTIONS DONE WITH NO FINDINGS AND MORE APPROVALS COMING!!!!!!!!
Which one will it be?
Generic version of Norco - $700 million according to IMS Health data.
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.
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.
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!!!!!!!!
$500 million + $700 Million + $30 million + $2.3 BILLION + $400 million + $1.6 BILLION = $5.44 BILLION market opening up to Elite (ELTP).
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).