Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Elite is well positioned for Success

Elite has 6 ANDAs filed and will be filing one a quarter going forward.
One Approval a quarter expected.

Elites 2018-2019 DollarLand Catalysts

NASDAQ,

Your list is incomplete. Consider Elite/Sungen ANDA #1:

Elite Pharmaceuticals And SunGen Pharma File ANDA
NORTHVALE, N.J., Feb. 08, 2018 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCBB:ELTP) 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.

This can only be generic Adderall (amphetamine/dextroamphetamine). It is the only immediate release stimulant with a U.S. market of $400 million. 9-10 competitors for most doses. Elite's ANDA was filed in February 2018, and with a ten month review cycle, we could hope for approval in early 2019. A majority of scripts for ADHD are for longer-acting drugs, like Concerta and Focalin XR, but Adderall immediate release remains well-liked. Adderall IR (generics) outperform all of the individual ER drugs and still command about 1/3 of the total ADHD market.


Elite/SunGen ANDA #1 is generic Adderall, and it will be a nice addition to the ELTP portfolio and a definite positive catalyst, hopefully in the next four months.