Teva, Anchen, and Impax gained rights to market 150-mg generic version of drug in 2008 and 300-mg in June 2007.
Biovail settled the lawsuit against Anchen Pharmaceuticals, Impax Laboratories, Watson Pharmaceuticals, and Teva Pharmaceutical Industries related to its antidepressant, Wellbutrin XL.
The agreement resolves patent-infringement litigation initiated by Biovail against certain parties that had filed ANDAs seeking approval to launch generic formulations of Wellbutrin XL before the expiry of its patents.
Wellbutrin XL is marketed by GlaxoSmithKline. The 150-mg and 300-mg versions together had U.S. sales in excess of $1.8 billion for the 12 months ending December 31, 2006, according to Wolters Kluwer Health.
With defined exceptions, neither Teva, Anchen, Impax, or Watson may market a generic version of the 150-mg strength of Wellbutrin XL until 2008. Biovail granted the companies an exclusive license to market a generic version of the 150-mg strength Wellbutrin XL for a period of 180 days following market entry. Thereafter, the license becomes nonexclusive.
Thus, Impax and Teva amended the strategic alliance agreement between them, such that Teva will market Anchen’s product and pay Impax a royalty rather than any profit share. Following the exclusivity period, Impax will market the 150-mg dosage strength either through Teva or on its own should Teva elect to continue marketing Anchen’s product.
Biovail, however, granted an exclusive license to Teva, Anchen, and Impax to market a generic version of the 300-mg strength of Wellbutrin XL, from December 13, 2006, until June 13, 2007. Thereafter, the license becomes nonexclusive. Under their initial strategic alliance agreement, Teva launched Impax’ 300-mg product in December 2006 pursuant to an exclusivity transfer agreement with Anchen, who was awarded first-to-file exclusivity for 300-mg dosage strength as well.
With defined exceptions, Biovail may be required to supply Teva with a limited amount of 150-mg and 300-mg Wellbutrin XL product at a predetermined supply price for specifically delineated periods of time.
Under the agreement, Biovail’s legal actions against Impax and Watson will be dismissed.