Friday, January 20, 2017 9:25:40 AM
"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. "
Recent IPCI News
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- Canadian Investment Regulatory Organization Trading Halt - IPCI • PR Newswire (Canada) • 03/06/2024 12:51:00 PM
- L'Organisme canadien de réglementation des investissements permet la reprise de la négociation - IPCI • PR Newswire (Canada) • 06/08/2023 05:30:00 PM
- Canadian Investment Regulatory Organization Trade Resumption - IPCI • PR Newswire (Canada) • 06/08/2023 05:28:00 PM
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