Barr reports patent challenge for Aggrenox by Boehringer Ingelheim

Barr laboratories, a subsidiary of Barr pharmaceuticals, has announced a challenge for a patent, listed by Boehringer Ingelheim relating to its Aggrenox capsules.

The parent company states that it was the first to file the abbreviated new drug application (ANDA)containing a paragraph IV certification of the drug – an aspirin/extended-release dipyridamole.

The capsules are indicated to limit the risk of stroke in patients who have suffered a completed ischemic stroke due to thrombosis or a transient ischemia of the brain.

Barr filed its generic Aggrenox product ANDA with the US Food and Drug Administration in January this year, before receiving acceptance in May. The firm then notified the New Drug Application holder and patent owner.

However, on July 11th Boehringer Ingelheim filed a suit attempting to prevent Barr from proceeding to market with the product.

According to IMS sales data for the year ending May 2007, Aggrenox capsules have sales of approximately $258 million (129 million pounds) in the US.

Last week Boehringer Ingelheim announced positive phase III results of its anticoagulant dabigatran etexilate – a drug which prevents coagulation through the inhibition of thrombin.