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Nostrum Sues FDA Over Exclusivity for Generic Carbatrol

June 1, 2011
Nostrum Pharmaceuticals has sued the FDA in federal court in New Jersey, claiming it has rights to 180 days of exclusivity for a generic version of 300-mg strength Carbatrol ER tablets. The company is seeking an injunction blocking the FDA from approving other ANDAs for the drug. Nostrum was the first filer for generic Carbatrol (carbamazepine), Shire’s anti-convulsant treatment that garnered the company more than $82 million in 2010 sales. First-filer status generally grants a company 180 days of exclusivity. But a May 20 letter from CDER Deputy Director Keith Webber explains that the exclusivity for the New Jersey-based company had already expired.
Drug Industry Daily