US Pharm. 2011;36(2):58.

Watson Pharmaceuticals, Inc., announced that its subsidiary, Watson Laboratories, Inc., has received approval from the FDA for Fentanyl Buccal tablets, USP, in 0.1-, 0.2-, 0.4-, 0.6-, and 0.8-mg strengths, the generic equivalent to Fentora tablets (Cephalon). Watson's Abbreviated New Drug Application (ANDA) for its generic Fentora is the first generic application approved by the FDA and may be entitled to 180 days of market exclusivity. A decision on a lawsuit by Cephalon alleging that Watson's product infringes various Cephalon patents was pending in the U.S. District Court for the District of Delaware. Watson cannot launch its product until this lawsuit is resolved.

Fentora had total U.S. sales of approximately $179 million for the 12 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 using other opioid medications around the clock for cancer pain.