Supplier News Breaks Archives
Watson approved for generic Fentora
January 11th, 2011
MORRISTOWN, N.J. – Watson Pharmaceuticals Inc. has received approval from the Food and Drug Administration for fentanyl buccal tablets, a pain reliever for cancer patients.
The company said Monday that its Watson Laboratories Inc. subsidiary gained approval from the FDA for fentanyl buccal tablets in strengths of 0.1, 0.2, 0.4, 0.6 and 0.8 mg. According to Watson, the medication is the generic equivalent to Cephalon's Fentora tablets.
Watson said its 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, according to the company.
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 noted, adding that it's currently enjoined from launching its product until a decision is rendered.
Citing IMS Health data, Watson said Fentora had total U.S. sales of about $179 million for the 12 months ending Nov. 30. Fentanyl buccal tablets are indicated to treat breakthrough pain in adult patients with cancer who are regularly using other opioid pain medicines around the clock for their constant cancer pain.