Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

The Bristol Myers Squibb-Pfizer Alliance is pleased with the decision by the U.S. Court of Appeals for the Federal Circuit upholding the Eliquis® Patents
PRINCETON, N.J. & NEW YORK, N.Y.

September 3, 2021 – The Bristol Myers Squibb-Pfizer Alliance today issued the following statement:

We welcome the decision by the Court of Appeals for the Federal Circuit’s to affirm the U.S. District Court’s August 2020 decision finding the composition of matter (COM) patent (US 6,967,208) and formulation patent (US 9,326,945) covering Eliquis® valid and infringed. Given today’s decision, the earliest that generic manufacturers are permitted to launch their apixaban products is April 1, 2028, subject to additional appeals and challenges.

https://news.bms.com/news/corporate-financial/2021/The-Bristol-Myers-Squibb-Pfizer-Alliance-is-pleased-with-the-decision-by-the-U.S.-Court-of-Appeals-for-the-Federal-Circuit-upholding-the-Eliquis-Patents/default.aspx


According to FDA Orange Book, there are currently 13 approved ANDA's for apixaban 2.5mg and 5mg tablets, none of them able to enter the market until at least 2028. Also according to Orange Book, Bristol Myers enjoys NPP exclusivity through 4/17/28 and pediatric exclusivity through 10/17/28. It is possible at least one of the ANDA's may have first to file exclusivity for 6 months after that. Looks like the earliest entry for Elite Pharma's version of apixaban is mid 2029.

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