June 25, 2012
/PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. -
, filed an Abbreviated New Drug Application (ANDA) with the U.S. 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
seeking to prevent Watson from commercializing its desvenlafaxine product prior to the expiration of U.S. 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 U.S. sales of approximately
according to IMS Health data.
About Watson Pharmaceuticals, Inc.
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. The Company is also developing biosimilar products in Women's Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. Watson has operations in many of the world's established and growing international markets.