Barr signs agreements to settle Mirapex and Aggrenox patent challenges

Separately, Barr Laboratories entered into a settlement agreement and a supply agreement to resolve the patent litigation regarding Boehringer Ingelheim’s Aggrenox product and Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals, entered into a co-promotion agreement with Boehringer Ingelheim relating to Aggrenox.

Under the Mirapex settlement agreement and license agreement, Barr Laboratories is permitted to launch its generic version of Mirapex commencing no later than January 1, 2010, approximately 10 months earlier than the expiration of the Boehringer Ingelheim patent at issue in the patent challenge litigation. Upon launch, Barr would pay Boehringer Ingelheim an undisclosed royalty amount.

Under the Aggrenox settlement agreement and supply agreement, Barr Laboratories is permitted to launch an authorized generic version of Aggrenox commencing no later than July 1, 2015, approximately 18 months earlier than the last-to-expire Boehringer Ingelheim patent listed in the FDA’s Orange Book. Upon launch, Barr would pay Boehringer Ingelheim an undisclosed royalty amount.

Under the Aggrenox co-promotion agreement, Duramed Pharmaceuticals is required to co-promote Aggrenox to obstetricians, gynecologists and other practitioners with a focus on women’s healthcare in the US using its specialty sales force. Under the terms of the agreement, Boehringer Ingelheim will train the 93- person Duramed specialty sales force, which will begin promoting Aggrenox in March 2009. Under terms of the agreement, Boehringer Ingelheim will pay Duramed undisclosed royalties based on net sales of Aggrenox.