www.fdanews.com/articles/180432-teva-named-in-patent-lawsuit-over-generic-belbuca-challenge
Teva Named in Patent Lawsuit Over Generic Belbuca Challenge
February 10, 2017
Teva Pharmaceuticals has been named in a patent infringement lawsuit as it attempts to develop a generic version of Belbuca, a long-acting opioid painkiller sponsored by BioDelivery Sciences International and Arius Two.
In a complaint filed in the U.S. District Court for the District of Delaware, BioDelivery and Arius claim Teva’s generic infringes upon two patents related to the drug’s methods of delivery, which do not expire until 2020 and 2027. Belbuca (buprenorphine) was first approved by the FDA in October 2015.
In its ANDA, filed in December 2016, Teva claimed sections of both patents were invalid.