Watson’s Generic Lidoderm Approval Leaves Questions About Exclusivity

 
• By Sue Sutter

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.

FDA approval of Allergan PLC’s Lidoderm generic has provided financial clarity for the company and regulatory clarity for subsequent ANDA filers referencing Endo Pharmaceuticals Inc.’s lidocaine patch, but questions remain about 180-day generic marketing exclusivity rights for the drug.

FDA said that although first-filer Watson may be eligible for 180-day exclusivity, the agency would not make a formal determination...

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