Shire Sues Two More Drugmakers Over Carbatrol

Shire has brought patent infringement lawsuits against Nostrum Pharmaceuticals and Apotex for filing applications to market generic versions of its anti-seizure drug Carbatrol.

Shire is suing Nostrum in the U.S. District Court for the District of New Jersey for filing an ANDA to market 100- and 200-mg versions of Carbatrol (carbamazepine). The two companies also are litigating in the same court over Nostrum’s ANDA to market a 300-mg version of the drug.

Shire sued Apotex in the U.S. District Court for the Eastern District of Texas for filing an application to market 100-, 200- and 300-mg versions of the drug.

Both Nostrum and Apotex informed Shire in May that they were filing ANDAs with Paragraph IV certifications on Carbatrol’s ’570 and ’013 patents. The ’570 patent expires in 2011, and the ’013 patent expires in 2016.

Carbatrol is indicated to treat seizure disorders and trigeminal neuralgia — episodes of sudden, brief, recurrent, stabbing facial pain.

Shire has another suit pending over Carbatrol. In May 2006, the firm sued CorePharma in the U.S. District Court for the District of New Jersey for infringing on the ’570 and ’013 patents. But Shire amended its complaint to drop the allegations with respect to the ’013 patent. Last month, CorePharma filed a motion for summary judgment of noninfringement on the ’570 patent.