Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

What about Collegium's Xtampza?

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...

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

Exclusivity Data

Product-----Exclusivity Code-----Exclusivity Expiration
005------------M-153----------------Apr 16, 2016
005------------NPP------------------Aug 13, 2018

Xtampza was a 505b2 NDA using Oxycontin as RLD. So how did Xtamza get Full Approval before FDA Exclusivity expired? Great question! Xtampza was given Final Approval on 4/26/16, which is exactly one week after expiration of the M-153 exclusivity (due to nasal abuse data). 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.

BTW, on the incredibly slim chance that IPCI's Rexista does not die hard at AdComm, because it also uses OxyContin as RLD, it will never receive Full Approval prior to August 13, 2018, unless it wins an OxyContin patent challenge in court prior to then. If Purdue does sue IPCI*, it triggers an automatic 30 month stay. If Purdue does not sue, Rexista is stuck in limbo until at least exclusivity expiration in August 2018.


*After FDA accepts Rexista NDA Application, IPCI has 20 days to notify Purdue of the Paragraph IV patent challenge. Purdue then has 45 days to file suit.