BIOVAIL ANNOUNCES WELLBUTRIN XL SETTLEMENT

Canadian drugmaker Biovail has announced it has reached a comprehensive settlement with Anchen Pharmaceuticals, Impax Laboratories, Watson Pharmaceuticals and Teva Pharmaceutical Industries related to Wellbutrin XL.

Biovail had initiated patent infringement suits against the companies, which had filed abbreviated new drug applications seeking approval to launch generic versions of Wellbutrin XL (bupropion HCl extended release) prior to the expiration of Biovail's patents, the company said.

As part of the settlement, Teva, Anchen, Impax and Watson may not market a generic version of Wellbutrin XL 150 mg before 2008. But Biovail has granted an exclusive license to Teva, Anchen and Impax to market a generic version of Wellbutrin XL 300 mg until June 13. After that, the license will be nonexclusive.

Biovail has also granted those three companies an exclusive license to market generic Wellbutrin XL 150 mg for 180 days following market entry, after which the license will be nonexclusive. In addition, Biovail may be required to supply Teva with a limited amount of 150- and 300-mg Wellbutrin XL product, at a predetermined supply price, for specifically delineated periods of time.

Teva said it plans to commercialize the 150-mg product under an agreement with Anchen, which was awarded 180-day statutory exclusivity for the product. Annual U.S. sales of Wellbutrin XL were approximately $800 million in 2006, according to Teva.

Biovail said its legal actions against Impax and Watson will be dismissed. Also, the suit involving Andrx's patent purportedly covering Wellbutrin XL 150 mg was dismissed, resulting in a license to GlaxoSmithKline to continue marketing the product.