Watson confirms OxyContin patent challenge; gets favorable Seasonique ruling

Watson Pharmaceuticals (NYSE: WPI) says that its subsidiaries, Andrx Labs and Watson Laboratories have filed Abbreviated New Drug Applications with the US Food and Drug Administration seeking approval to market oxycodone hydrochloride extended-release tablets in the 10,15, 20, 30, 40, 60 and 80mg strengths, a generic version of Purdue Pharma's OxyContin, which are indicated for the management of moderate to severe pain when continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Purdue filed suit against Watson on March 23, 2011 in the US District Courts for the Southern District of New York, District of Delaware and Southern District of Florida seeking to prevent Watson from commercializing its products prior to the expiration of US Patents Nos. 6,488,963, 7,674,799, 7,674,800, 7,683,072 and 7,776,314. Purdue’s law suits were filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDAs until August, 2013, or until final resolution of the matters before the courts, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be the first applicant to file ANDAs for several strengths of OxyContin and, should the ANDAs be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending December 31, 2010, OxyContin had total US sales of around $3.1 billion, according to IMS Health data.