FDAnews Drug Daily Bulletin

SHIRE FILES PATENT SUIT AGAINST COREPHARMA

May 30, 2006
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Shire Laboratories has sued Corepharma after it filed to market a generic version of Shire's seizure drug Carbatrol, Shire said recently.

Carbatrol (carbamazepine) is indicated for the treatment of seizure disorders and trigeminal neuralgia, episodes of sudden, brief, recurrent stabbing facial pain. The drug had sales of $14.1 million in the first quarter of 2006, down 17 percent from the first quarter of 2005.

Shire was notified March 30 that Corepharma had filed an abbreviated new drug application to market generic Carbatrol in 100-, 200- and 300-mg doses. The lawsuit triggers a stay of FDA approval of up to 30 months from Corepharma's notice to allow the court to resolve the suit, Shire said.