Watson Pharmaceuticals announced that its subsidiary, Watson
Laboratories, Inc., has received approval from the 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