Watson’s Generic Lidoderm Approval Leaves Questions About Exclusivity
FDA will not decide whether the first-filer is entitled to 180 days of marketing protection until another ANDA is ready for full approval. Watson “believes” it holds marketing exclusivity for Endo’s pain patch even though it failed to obtain tentative approval within the statutory 30-month timeframe.
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Expanded technological capabilities, narrowed focus on alternative dosage forms and harder-to-replicate products, and growing international reach are among the strategies being employed by Teva, Mylan and Watson in the face of 2013’s anticipated reverse patent cliff.
In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
The agency distinguishes the lidocaine pain patch from topical dermatological drugs intended to treat skin diseases in rejecting Endo’s call that ANDA sponsors demonstrate bioequivalence through clinical trials, rather than merely pharmacokinetic studies.