Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Most recent OxyContin exclusivity updates I can find.


1st link says Supreme Court declined to hear the case just 60 days ago. 2nd link if you like the patent technical mumbo jumbo, but it all boils down to everyone already knows that hydrogenation can be used to separate impurity isomers, duh. Although it seems Purdue is out of patent appeals, best I can tell is we will not see any full approvals of generic OxyContin ANDAs until at least August 2018. Purdue was given additional 3 years of FDA exclusivity when they submitted additional data and received pediatric approval in 2015, as is seen in 3rd link to FDA Orange Book (code "NPP"). Before that in 2013 they got an extra 3 years of exclusivity due to nasal abuse data (code M-153), so who knows what they'll come up with next...


https://www.bna.com/no-high-court-n57982082749/

http://patentlyo.com/patent/2016/02/deterrent-oxycontin-invalid.html

http://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=022272&Appl_type=N

November 15, 2016
No High Court Review of Purdue OxyContin Patent Invalidity

By Tony Dutra

Nov. 14 — Purdue Pharma L.P. lost its last chance Nov. 14 to use patent protection to stall certain generic versions of its best-selling painkiller, OxyContin.

The U.S. Supreme Court rejected two petitions for review of U.S. Court of Appeals for the Federal Circuit rulings. The appeals court held that three Purdue patents on a less toxic formulation known as low-ABUK oxycodone were invalid as obvious, and that Grünenthal GmbH’s patent on making OxyContin resistant to abuse was not novel. Purdue licenses Grünenthal’s patent.