What we know from the ELTP Q1 2024 transcript and the recent news.
Transcript - The Company also submitted partial ANDA for pain management for FDA review. The partial application contained the recently concluded insufflation study. Elite received correspondence from FDA requesting certain information. The information has been gathered and the response will be out to FDA this week. This is one of the three needle mover products that I spoke of six weeks ago.
Elite has another product that is undergoing a pivotal DE clinical trial. If we pass then we expect to file this ANDA this year. Just to make sure that everybody understands me, two of the three needle mover ANDAs as I spoke of will be filed this year.
Now, from the Reuters article on Aug 31, 2023 - The U.S. Food and Drug Administration had said on Monday it has approved generic versions of Vyvanse from 11 drug makers after Takeda's exclusivity over the drug expired on Aug 24.
Now from the ELTP news release - Elite Pharmaceuticals Reports Positive Results From A Pivotal Bioequivalence Study - "The results indicate that the generic product is bioequivalent to the branded product. Elite is compiling the data for this product to file an Abbreviated New Drug Application with the US Food and Drug Administration."
Now, knowing how approvals go, if one of the 11 drug makers has 180 days exclusivity, that will expire by the time ELTP gets approval and launches.
Now, who cares about 180 days? ELTP's generic Adderall IR has a Market Size $335 MILLIOM with 15 competitors and they are pulling in millions! When approved, ELTP's generic versions of Vyvanse will have a Market Size of $5.1 BILLION (again $$BILLION) with 11 competitors (again 11 which is 4 less than generic Adderall)!!! Do the math, if ELTP gets just 1% of the market they will have $51 MILLION or even 5% of the market they will be looking at $255 MILLION.
THIS IS FROM JUST ONE OF THE TWO NEEDLE MOVERS!!!
With Mr. Kirko driving sales and distro, with CURRENT customers of retailers such as CVS, Walgreens, Publix, Myers (which is actually Meijer, transcript error probably), Optisource, Golden Oaks, Red Oaks, and probably more customers signing on, I think ELTP will be closer to the 5% market.
Then we get approval for the second needle mover and add another 5% of $1.16 BILLION!!!
Given we will not see all this potential revenue in 2023 but 2024 will be blast off into the HUNDREDS of MILLIONS in revenue!!! I can wait for that : )
