Replies to post #197503 on Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Great Question

Won't ELTP have to wait for Pfizer's patent to expire before a generic is allowed?

The 505b2 pathway is for New Drug Application (NDA), meaning we would not be applying as a generic of ALO-2 but rather as new drug piggy-backing off of ALO-2 safety/efficacy data by proving bioequivalence. It would probably be marketed as a generic of ALO-2, and I guarantee Nasrat will undercut Pfizer price. But I do not know if standard "DAW" rules would apply. For instance, one can prescribe "Norco" but unless the "Dispense As Written" box is checked then it will automatically be substituted for generic acetaminophen/hydrocodone. This is a law in some places and insurance requirement in most. It would make a huge difference.

If a prescriber writes for ALO-2, can/should the pharmacist automatically substitute cheaper ELI-201? Substitute ELI-?01 for Embeda? Hmmmmmmmmmm.

One thing I know for sure, even though the FDA loves these non-generic generics, Pfizer hates them. Seems hard to believe it would not be litigated. From the Camargo site:


http://www.camargopharma.com/Userfiles/Docs/camargo-505b2.pdf

The 505(b)(2) strategy has been underutilized in the 16 years since it was legislated. One reason might
be the recent controversy over its constitutionality, as Pfizer and other large pharmaceutical companies
have petitioned against approvals of 505(b)(2) NDAs. They argue that it is unconstitutional for the FDA
to rely on the innovator’s proprietary data and that this application violates Fifth Amendment rights. No
court decision has yet been rendered on the constitutionality, but in October, the FDA released a
statement reaffirming their interpretation of Section 505(b)(2) and rejecting many petitioners’ complaints

[NASDAQ2020]

It will be a new drug , but Elite can charge generic pricing to compete with ALO-02 ER Oxy ADF

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