Biovail Corp. has reached a settlement, following a review by the Federal Trade Commission, with Anchen Pharmaceuticals LLP, Impax Laboratories, Inc., Watson Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd., related to Wellbutrin XL. Biovail had initiated patent-infringement litigation against companies that had filed aNDAs seeking approval to launch generic formulations of Wellbutrin XL, prior to the expiry of its patents.

Terms of the settlement include: dismissal of Biovail’s legal actions against Impax and Watson; Teva, Anchen, Impax, and Watson may not market a generic version of the 150mg strength of Wellbutrin XL until 2008; Biovail has granted an exclusive license under its patent to Teva, Anchen, and Impax to market a generic version of the 300mg strength of Wellbutrin XL, from December 13, 2006 until June 13, 2007, and Biovail has granted these companies an exclusive license to market a generic version of the 150mg strength for a period of 180 days following market entry. Thereafter, each of the licenses becomes non-exclusive. Biovail may be required to supply Teva with a limited amount of 150mg and 300mg Wellbutrin XL product, at a pre-determined supply price, for specific periods of time.

Also, the terms of an agreement between GlaxoSmithKline and Andrx Corp. regarding Andrx’s patent-infringement suit for its patent supposedly covering the 150mg Wellbutrin XL product, was dismissed. GSK was granted a license to continue to market the product. Biovail has agreed to pay one-third of the license costs. As a result of this settlement, all outstanding impediments affecting the 150mg Wellbutrin XL product were extinguished.

Separately and independently of these settlements relating to Wellbutrin XL, Biovail and Watson have terminated their existing agreement, which provided Biovail certain access to reference Watson’s diltiazem toxicity data. As a result, Biovail is no longer obligated to pay Watson an annual royalty.