Thursday, August 16, 2012

Actos Exclusivity - Watson files motion for Temporary Restraining Order, seeks to enjoin FDA from granting Final approval to any ANDA for Actos

 USFDA recently  denied Watson exclusivity on Actos, and this was positive for Ranbaxy,  Mylan and Teva (Authorized Generic) who were the other generic players expected to share exclusivity with Watson on Actos.
However in reaction to this FDA action, Watson has sued USFDA, and through its complaint seeks to enjoin  USFDA from granting final approval to any ANDA for generic Actos  prior to granting approval to Watson ANDA.

A hearing on this complaint is scheduled on August 15th, which should decide the fate for Watson, including other generic players (Ranbaxy, Teva, Mylan). If the motion is denied, Ranbaxy and Mylan should gain because of reduced competition for the pie.

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