PARSIPPANY, N.J., Oct. 7, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Morphine Sulfate and Naltrexone Hydrochloride Extended-release Capsules 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg, 80 mg/3.2 mg, and 100 mg/4 mg. Watson's Morphine Sulfate and Naltrexone Hydrochloride Capsules are generic versions of EMBEDA® Extended Release Capsules sold by King Pharmaceuticals, Inc., a wholly-owned subsidiary of Pfizer Inc. EMBEDA® is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Pfizer, King and Alpharma Pharmaceuticals LLC filed suit against Watson on October 6, 2011, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 7,682,633; 7,682,634; and 7,815,934. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing 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 EMBEDA® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve months ending August 31, 2011, EMBEDA® had total U.S. sales of approximately $42 million according to IMS Health data.
About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is a leadin
|SOURCE Watson Pharmaceuticals, Inc.|
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