Fentanyl Citrate
In the U.S., Barr markets an oral transmucosal fentanyl citrate product,
which is the generic version of Cephalon's ACTIQ® (oral transmucosal fentanyl citrate) [C-II], 200 mcg, 400 mcg, 600 mcg, 800 mcg,
1200 mcg, and 1600 mcg cancer pain-management product.
The Company launched this product in September 2006 under a license agreement
previously granted by Cephalon in August 2004, pursuant to a Federal Trade Commission order. The license grants Barr a non-exclusive
right to sell a generic version of ACTIQ. Under the licensing agreement, Cephalon is currently supplying the Company with fentanyl
citrate manufactured under Cephalon's NDA, which Barr has the right to market. The Company's ANDA is currently under active review
at the FDA. Barr's product competes with Cephalon's authorized generic, which Cephalon has licensed to a third party.