Caraco Pharmaceutical Laboratories, Ltd, Detroit, has been granted tentative approval by the FDA for Modafinil tablets, 100mg and 200mg.
Modafinil is prescribed for excessive sleepiness associated with narcolepsy. This new product is the bioequivalent to Provigil, a registered trademark of Cephalon Inc. Provigil tablets had U.S. sales of approximately $753 million for the 12-month period ended March 31, 2007, according to IMS Data.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are extremely pleased to receive this tentative approval. Modafinil was filed with a paragraph IV certification that we do not infringe and or that the Cephalon patent is invalid.”
Movens added that Caraco was not sued by Cephalon, and that the company anticipated marketing Modafinil following the expiration of Provigil’s patent and exclusivity period.
