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Watson Confirms Pristiq® Patent Challenge

26-Jun-2012 | Source : | Visits : 11177
PARSIPPANY, NJ - Watson Pharmaceuticals Inc. today confirmed in a press release that its subsidiary, Watson Laboratories Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market Desvenlafaxine Succinate Extended-release Tablets, 50 mg and 100 mg. Watson's ANDA product is a generic version of Pfizer's Pristiq®, which is indicated for the treatment of major depressive disorder (MDD) in adults. 

Pfizer Inc., Wyeth LLC, Wyeth Pharmaceuticals Inc., and PF Prism C.V. filed suit against Watson on June 22, 2012 in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its desvenlafaxine product prior to the expiration of US Patent No. 6,673,838. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA until August 29, 2015 or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities. 

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Pristiq® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. 

For the twelve months ending April 30, 2012, Pristiq® had total US sales of approximately $559 million according to IMS Health data. 

Watson Pharmaceuticals Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.

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