The agreement, following US Federal Trade Commission review, resolves litigation between Teva’s supplier of the 300 mg product, Impax Laboratories, and Biovail, involving a patent which expires in 2018.
The agreement also releases both Teva and Impax for past sales of that product. Annual brand sales in the US were approximately $972 million at the time of launch, according to IMS data. Teva will continue to market generic bupropion tablets, 300 mg, on an exclusive basis for six months from launch and non-exclusively thereafter.
In addition, Teva received a license to sell bupropion tablets, 150 mg, in 2008 and possibly earlier under certain circumstances. Teva plans to commercialize the 150 mg product by agreement with Anchen, which was awarded 180-day statutory exclusivity for the product.