Elite Pharmaceuticals Inc (ELTP)

[carbonfiltered]

Generic abuse deterrent OxyContin is going to get approved, Perdue can't do a damn thing about it.

http://www.fiercepharma.com/sales-and-marketing/purdue-loses-a-battle-war-against-oxycontin-generics

It's bad news for Purdue Pharma but good news for generics makers such as Teva Pharmaceutical Industries ($TEVA). A federal appeals court affirmed a lower court's decision to toss out some Purdue patents for its top-selling pain drug OxyContin, further opening the door to cheap knockoff versions of the blockbuster med.

AND THIS:

"What one might gather from the Board’s memorandum is that the scope of the period of 3-year exclusivity for OXYCONTIN expiring on April 16, 2016 applies to the particular drug product formulation studied in clinical trials, and not broadly to prevent approval of all oxycodone extended-release drug products with abuse-deterrence labeling. That would seem to be consistent with other FDA decisions. For example, on January 4, 1999, FDA approved ANDA 075102 for Propofol Injectable Emulsion, 1% (10 mg/mL), notwithstanding a period of 3-year exclusivity on the reference listed drug, DIPRIVAN, that was not scheduled to expire until June 11, 1999. The period of 3-year exclusivity applicable to DIPRIVAN was based on FDA’s approval of a NDA Supplement for a version of the drug product formulated with EDTA as a preservative. FDA determined that the ANDA sponsor, whose drug product was formulated with sodium metabisulfite as the preservative in place of EDTA, was not subject to the exclusivity applicable to the EDTA-formulated version of DIPRIVAN because the scope of 3-year exclusivity was limited to the drug product formulation."