Watson confirms patent challenge of generic Daytrana

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 Methylphenidate Transdermal System, 10 mg/9 hrs, 15 mg/9 hrs, 20 mg/9 hrs, and 30 mg/9 hrs.  Watson's Methylphenidate Transdermal System products are generic versions of Noven Pharmaceuticals, Inc.'s Daytrana(R).  Daytrana(R) is a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Noven filed suit against Watson on October 13, 2011 in the United States District Court of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 6,210,705 and 6,348,211.  Noven's 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 Noven 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 versions of Daytrana(R)  and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending July 31, 2011, Daytrana(R) had total U.S. sales of over $87 million according to IMS Health data.