Alkem Laboratories, Forest Laboratories, Indchemie Health Specialties Pvt. Ltd., Torrent cardiovascular news
Forest and the generics companies settled a March suit claiming ANDAs from the companies for their generic versions of hypertension drug Bystolic nebivolol infringes Forest's U.S. Patent No. 6,545,040. The patent covers methods of treating hypertension with Bystolic and expires in December 2021. Under the settlement, Alkem, Torrent and Indchemie will receive a license to market their generic versions of Bystolic by the later of either three months prior to the expiration of the '040 patent, including any extension and/or pediatric exclusivities; or the date FDA approves an ANDA or earlier in undisclosed circumstances. The suits against Alkem and Indchemie were filed in the U.S. District Court for the Northern District of Illinois, while the suit against Torrent was filed in the U.S. District Court for the District of Delaware and transferred to the Illinois court in June. In October, Forest settled a similar case against Hetero Drug Ltd. (Hyderabad, India) (see BioCentury, March 19 & Nov. 5). ...