Elite Pharmaceuticals Inc (ELTP): What about Epic's generic OxyContin?...

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Elite Pharmaceuticals Inc (ELTP)

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Re: WeeZuhl post# 239722

Friday, 01/20/2017 1:12:18 AM

Friday, January 20, 2017 1:12:18 AM

What about Epic's generic OxyContin?

Why does the Pediatric Exclusivity not apply to Xtampza? The answer, I believe, is that a specific provision in Hatch-Waxman Act says that Pediatric Exclusivity does not apply to NDA/ANDA applications which have won their Paragraph IV Certification patent challenge in court, as Collegium did. Thus, the successful patent litigation allowed Xtampza approval while the NPP Exclusivity is still valid.

Epic won in court and should bypass Pediatric Exclusivity. Supreme Court declined Purdue's appeal sixty days ago. I believe PuraCap could get their generic OxyContin ANDA approval very soon.

Historic note: Until his life's destiny was further clarified, Robin Hood spent several years robbing from the rich and giving to the porcupines. (G. Larson 7/26/82)

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