Watson receives FDA approval for generic Fentora

Jan 10 2011

Watson Pharmaceuticals, Inc. (NYSE: WPI) today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ^® tablets.

Watson's Abbreviated New Drug Application (ANDA) for its generic version of FENTORA^® is the first generic application approved by FDA, and as such, may be entitled to a 180-day period of market exclusivity.  FDA will make a formal determination concerning Watson's entitlement to market exclusivity only in the event another Paragraph IV ANDA becomes eligible for final approval prior to 180 days after Watson's product launch or the expiration of listed Orange Book patents.  A decision on Cephalon's lawsuit alleging that Watson's product infringes various Cephalon patents remains pending in the U.S. District Court for the District of Delaware.  Watson is currently enjoined from launching its product until a decision is rendered.

Fentora ^® had total U.S. sales of approximately $179 million for the twelve months ending November 30, 2010, according to IMS Health.  Fentanyl Buccal tablets are indicated to treat breakthrough pain in adult patients with cancer (18 years of age and older) who are regularly using other opioid pain medicines around-the-clock for their constant cancer pain.