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I’m not sure, not an expert on the process. I assumed they typically filed all together for all the dosages they could confidently replicate and successfully trial as bio equivalent.
Once the initial dosage is approved, isn’t it relatively easy and quick to get the other quantities or dosages approved rapidly??
I think you’re right. Isn’t it available in several dosages and routes though, such as PO and IV?
Maybe the $42M market size is because they got approval only for the 2.5mg PO?
Glad to see the Methotrexate approval on 5-16-2024! I did think the antimetabolite ANDA was Arava generic because the $42 million market size is an exact match. Sometimes it's good to be wrong. I think the methotrexate tablet market size is bigger then $42 million.... perhaps I'm wrong about that also lol.
IDK. Not even sure if he owns that many shares.
I wonder what other board he polluted for the last 3 months lol
He also said the gap would never get hit. Yet, wrong again. Not the brightest star. Oh well.
You are history self crowned king
Bbye…
HOLY SH*T you're PHUCKIN' good!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Are you phuckin' kidding me right now!!!!!!!!!???????
February 16 - GDUFA date
***3-month minor amendment review***
May 16 - APPROVED
WeeZuhl is STUNNED in disbelief.
WeeZuhl: "The methotrexate bioequivalence study in India was never started."
The King: "Methotrexate is the name of the undisclosed antimetabolite. It was supposed to be approved in February but received a CRL. The BE study date, BE press release, ANDA filing date, drug class, IQVIA, all line up in sync."
Conclusion: WeeZuhl ACTUALLY thought he could outsmart THE KING himself. You have GOT to be kidding me!!!!!!!!!! Shaking my head.....
The King does it again!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Holy SH*T you're phuckin' GOOD!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
APRIL 7, 2024: https://investorshub.advfn.com/boards/read_msg.aspx?message_id=174193094
Came out April 20th last year
I think we have the other small FDA submission that will be approved next. We also have legal hurdles with Purdue for opioid that need to be overcome.
Opiate analgesics next? $720 million So based on info provided by Winechemist's excellent guidance GUDUFA target date assigned, from his experience this is running 9-12 months out. We know Elite filed an Abbreviated New Drug Application (ANDA) on August 17, 2023, and was accepted for review by the US Food and Drug Administration (FDA) on September 19, 2023 for an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.
FDA approval could come as soon as JUNE/JULY this summer.... or later OCT/NOV but we are seeing that ELITE has a pattern of getting approvals.
Just gets better and better and will go higher and higher!!!
Catalyst check off:
X 1. Cash Flow Positive Status - 5 years
X 2. Purchase building housing their cGMP registered facility for research, development, manufacturing and packaging of pharmaceutical products.
X 3. Adderall IR $335 Million Approved and Launched
X 4. Adderall XR $1.56 Billion Approved and Launched
X 5. Double digit quarterly revenues in millions
X 6. In house marketing and distribution: Kirko Kirkov, Doug Plassche and their teams
X 7. Prasco/Burel Adderall agreement starting January 1st 2024
X 8. First shipment Adderall XR to PRASCO Dec 2023
X 9. DEA increases manufacturing quotas for Adderall & Vyvance
X 10. Generic Vyvanse - $5.1 BILLION - FDA submission Dec 2023
X 11. FDA Acceptance of Generic OxyContin Sept 2023
__12. Dopamine Agonist (probably Requip XL or Mirapex ER). $12 Million
X 13. Vigabatrin Approval $233 Million
X 14. Pyros Settle Vigabatrin -VigPoder trade mark challenge then LAUNCH
X 15. Generic Methotrexate Approval- Antimetabolite $42 Million
__16. $50 million in yearly revenues
X 17. Lease additional manufacturing space and storage vault for new Needle Mover ANDAs - Jan 2024
X 18. Lowest PE ratio for OTC Healthcare sector
X 19. Become the ONLY company showing growth on the OTC WHILE BEING PROFITABLE
__20. Generate revenues over $20 million/quarter
__21. Generic OxyContin Approval - FIRST TO FILE Aug 17, 2023 $720 Million
__22. Prevail over Purdue in Generic OxyContin infringement suit - 6 month stay
__23. European distribution - Dexcel partnership approval by Israeli Health
__24. Full ownership of Adderall IR $ 335 Million
__25. Full ownership of Adderall XR $ 1.56 Billion
__26. Generic Concerta- $1.2 BILLION FDA submission
__27. $100 million in yearly revenue
__28. Generic Vyvanse Approval and Launch
__29. $200 million in yearly revenue
__30. Deep pocket partner for SequestOx
__31. Patented Unique ADF (w/o naltrexone)-- NDA
__32. Mikah ANDA (s)
__33. Undisclosed ANDAs/NDAs
__34. DollarLand PPS
__35. Big Pharma bid
__36. Uplist to the NASDAQ Exchange
__37. ELTP Elite Pharmaceutical Buyout - less than 2 1/2 years from Feb 2024
__38. Vegas Baby !!!!!!!
My mistake not needle mover
Ooops sorry distegatd
NAS, yes you are correct, that was global.
From Elite's PR on FDA acceptance - $42 million
April 20, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for an undisclosed generic drug product in a class of medications called antimetabolites. IQVIA reported annual sales for the twelve months ending December 2022 of $42 million for the generic market for this product.
That maybe the global market ?
The market sizes may include injectable Methotrexate
Tablet market maybe smaller?
The PR will probably tell us.
Shortages:
FDA shortage link
for Adderall:
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Amphetamine%20Aspartate%20Monohydrate,%20Amphetamine%20Sulfate,%20Dextroamphetamine%20Saccharate,%20Dextroamphetamine%20Sulfate%20Tablet&st=c&tab=tabs-1
FDA shortage link for Vyvance
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Lisdexamfetamine%20Dimesylate%20Capsule&st=c
FDA shortage link for Concerta
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Methylphenidate%20Hydrochloride%20Tablet,%20Extended%20Release&st=c
FDA shortage link for Naltrexone
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Naltrexone%20Hydrochloride%20Tablet&st=c
FDA shortage link for Methotrexate
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Methotrexate%20Sodium%20Tablet&st=c
Awesome to hear. Thx
Excellent due diligence guys. Thanks. Strong hands will help make this trade at fair value with a value appropriate pe ratio.
Methotrexate Sodium Market was US$ 95 million in 2023 and is expected to reach US$ 141.7 million by 2030, at a CAGR of 5.8% during the years 2024
ELTP's FDA Orange Book link -
https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
Click on the "Appl. No." twice and it will sort from most recent to oldest approvals.
METHOTREXATE SODIUM comes to the top when you sort the application number twice.
Long-term capital gains tax rate 2024:
Capital gains tax rate Single (taxable income)----- Married filing jointly (taxable income)
0%---------------------- Up to $47,025---------------- Up to $94,050
15% ---------------------------$47,026 to $518,900------ $94,051 to $583,750
20% ----------------------------Over $518,900------------- Over $583,750
I have 66% of my ELTP in Roth
33% in non Roth accounts.
Its Elite - ELTP - straight from the FDA Orange Book -
Active Ingredient: METHOTREXATE SODIUM
Proprietary Name: METHOTREXATE SODIUM
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 2.5MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216453
Product Number: 001
Approval Date: May 16, 2024
Applicant Holder Full Name: ELITE LABORATORIES INC
Marketing Status: Prescription
Patent and Exclusivity Information
Another market analysis
Nifedipine Market Overview
Nifedipine Market size is estimated to reach $1.7 billion by 2027, growing at a CAGR of 4.1% during the forecast period 2022-2027. Nifedipine falls under the category of calcium channel blocker drugs which is widely used to treat complications such as chest pain (angina), Hypertension, preterm labor, Prinzmetal angina (=squeezing of blood vessels), Raynaud’s phenomenon (= numbing of several parts). There are many other dihydropyridine calcium channel blocker drugs including nitrendipine and nisoldipine for treating HBP problems. In recent years, abnormalities like premature labor are emerging and are stirring the demand for the aforementioned drugs. Tocolytics are used to suppress preterm by stopping the contraction of muscles cells. Similarly, nifedipine helps prevent preemies from health hitches that they’re susceptible to by virtue of premature births. Elevating prevalence of health issues like HBP, arrhythmia, and other chronic illnesses are factors set to drive the growth of the Nifedipine Industry for the period 2022-2027.
As per the current market research conducted by the CMI Team, the global Nifedipine Market is expected to record a CAGR of 8.1% from 2023 to 2032. In 2023, the market size is projected to reach a valuation of USD 824.3 Million. By 2032, the valuation is anticipated to reach USD 1,661.5 Million.
You grabbed the link for the company every one said it wasn’t. The orange book clearly notes Elite laboratories inc. Search on that.
It is absolutely us.
Within 3 business days of a material event.
I’ve never seen Elite Pharmaceutical Solution, LLC. Interesting
The PR on Monday will give us an updated market valuation …..yeah baby!
Thanks. I prefer an announcement on a Monday instead of Friday anyway.
That other Elite focuses on sports supplements and the like. Not our territory.
It is material
They have 4 business days to pr it
Yes definitely the antimetabolite. Elite pr'd this at a 42 million market.
I was thrown off by the market size discrepancy. This was actually rather simple. Ignore my other posts
It seems to be the antimetabolite that was supposed to be approved in Feb. winechemist nailed the 3 month delay for minor issue he described in his recent post. Hope to see the PR on Mon reflect a higher market value. I think the 500 million is a global number. I saw websites that listed that number global and some that said it was domestic. I am going to believe Elite. There is also a shortage.
Thank you for the uplifting news going into the weekend!!!
If it’s considered a material event, don’t they have to file something? I’m not sure at what point a new drug approval is considered material, though.
Congrats longs.
Congrats team on a great find!!!
Can someone confirm the market size?
Thx
I'm glad to be wrong about this.
This would have to be the first time in 15 years that an approval would come completely out of the blue. They always have issued a pr for positive phase 3 studies and fda filing. Don't know what to make of this but look forward to clarification Monday. Who knows, this might actually be ELTP.
Though it'd kind of look bad, since Nasrat stated multiple times in past CC's that there were no drugs meeting milestones that would go not communicated.
Guess we will see soon.
RX NIFEDIPINE NIFEDIPINE A212016 TABLET, EXTENDED RELEASE ORAL 90MG AB2 ELITE PHARMACEUTICAL SOLUTION INC
Great News! I was wrong.
The other company was "Elite Pharma".
Elite Laboratories is ELTP.
https://elite.irpass.com/Elite-Pharmaceuticals-Inc-Issues-Statement-on-Product-Approval-Listing-11-24-2020
Years ago there was unexpected approval in the orange book and elite put on a pr saying it was not them. I know it sounds strange, but I think that other company was "elite laboratories", meaning this approval was probably not for ELTP.
It was tremendously confusing at the time.
I've been trying to buy another 100K...hopefully Tuesday.
Thank you excellent find
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Moderators jimr1717 mrwrn2010 NASDAQ2020 IB_ namtae Dr JoeBarducci |
Elite needs a Board of Directors that represents all shareholders !!!
Senior Moderator: IB_
Posted: 6/5/23
________________________________________________________________________________________________________________
Elite Pharmaceuticals, Inc. |
Website | Location | Employees | Facility | CEO |
www.elitepharma.com | Northvale, New Jersey | 53 | 55,000 sq ft | Nasrat Hakim |
Products & Pipeline | ||||
Drug | Market Size | Status | Competitors | Marketed By |
Adderall IR | 389.8 M | On Market | 15 | Elite |
Adderall XR | 1.56 B | On Market | 10 | Elite & Prasco |
Dantrolene | 6.3 M | On Market | 2 | Elite |
Isradipine | 5.5 M | On Market | 1 | Elite |
Loxapine | 5 M | On Market | 2 | Elite |
Phendimetrazine | 4.5 M | On Market | 4 | Elite |
Trimipramine | 2 M | On Market | 1 | Elite |
Naltrexone | 16 M | On Market | 5 | Precision Dose |
Phentermine Capsules | 7.5 M | On Market | 6 | Precision Dose |
Phentermine Tablets | 40 M | On Market | 8 | Precision Dose |
Vigabatrin | 233.7 M | On Market | 13 | Pyros |
Doxycycline | 85 M | Approved (Discontinued) | 9 | ---------- |
Tylenol with Codeine | 45 M | Approved (On Hold - Opioid) | 5 | ---------- |
Dopamine Agonist | 12 M | Filed with FDA - 22 Dec 2022 | ---------- | ---------- |
Methotrexate | 64.3M | Approved - 16 May 2024 | 8 | Elite |
OxyContin | 720 M | Filed with FDA - 17 Aug 2023 | ---------- | ---------- |
Vyvanse | 5.1 B | Filed with FDA - 21 Dec 2023 | 14 | ---------- |
Concerta | 1.16 B | In Development (Final Stages) | 9 | ---------- |
Financials | ||||
Fiscal Year | Revenue | Change | Net Income | Change |
2019 | 7,568,508 | ---------- | (9,279,321) | ---------- |
2020 | 17,994,639 | +137.76% | (2,240,351) | +75.86% |
2021 | 25,380,749 | +41.05% | 5,088,421 | +327.13% |
2022 | 32,262,117 | +27.11% | 8,898,245 | +74.87% |
2023 | 34,155,114 | +5.87% | 3,561,846 | -59.97% |
2024 Q1 | 8,980,076 | +17.04% | 1,141,809 | +273.28% |
2024 Q2 | 14,157,185 | +64.90% | 14,934,601 | +866.0% |
2024 Q3 | 15,538,800 | +68.00% | 3,500,000 | +80.0% |
FY 2024 Projected | Minimum Projected: 50,000,000 | Minimum YOY Projected Increase of 68.31% | ||
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