Forest in patent settlement with Glenmark; Watson generic Lysteda cleared; and Dr Reddy's debuts generic Propecia

US drugmaker Forest Laboratories (NYSE: FRX) has entered into a settlement agreement with US subsidiaries of India’s Glenmark in patent infringement litigation brought by Forest in response to Glenmark's Abbreviated New Drug Application seeking approval to market generic versions of Forest's Bystolic (nebivolol) tablets.

This settlement is in addition to the previously announced Bystolic patent infringement deals with Hetero Labs, Alkem Laboratories, Indchemie Health Specialties and Torrent Pharmaceuticals (The Pharma Letter November 29, 2012).

Specifically, under the terms of the settlement agreement and subject to review of the settlement terms by the US Federal Trade Commission, Forest will provide a license to Glenmark that will permit it to launch its generic versions of Bystolic as of the date that is the later of (a) three calendar months prior to the expiration of US Patent No 6,545,040, including any extensions and/or pediatric exclusivities or (b) the date Glenmark receives final Food and drug administration approval of its ANDA, or earlier in certain circumstances. Similar patent infringement litigation brought by Forest against Amerigen Pharmaceuticals and Watson Pharmaceuticals, and related companies and subsidiaries thereof, remains pending in a multidistrict litigation established in the US District Court for the Northern District of Illinois.