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WOODCLIFF LAKE, N.J., July 12 (UPI) -- U.S. firm Barr said Thursday it is challenging the patent on Boehringer Ingelheim's stroke drug Aggrenox so it can make a generic copy.
Barr said it filed in January with the Food and Drug Administration for approval of aspirin/extended-release dipyridamole 25 mg/200 mg capsules, adding that it believes it is the first company to try to market a generic copy of the brand drug. If Barr is the first generic to market, it would be entitled to six months' market exclusivity.
After the FDA notified Aggrenox's maker of the filing, Boehringer Ingelheim this week filed suit in the U.S. District Court for the District of Delaware in an attempt to block Barr's marketing its generic product.
Barr estimated U.S. sales of Aggrenox at approximately $258 million for the 12 months ending May 2007, based on data from IMS Health.
Aggrenox is indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
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