By Mark Chael —

On December 2nd, Mylan, Inc. and Mylan Pharmaceuticals, Inc. announced that they had settled their dispute with Novartis Pharmaceuticals Corp., Novartis Corp., and Novartis International AG over a generic version of Novartis' Femara® tablets.

According to the press release, Femara® tablets, which are used in the treatment of breast cancer, had U.S. sales of about $470 million for the 12 months ending September 30, 2008.

Novartis initiated the dispute in June of 2006, when it sued Mylan following Mylan's filing of an ANDA with a Paragraph IV certification seeking approval to market generic letrozole tablets prior to the expiration of U.S. Patent No. 4,978,672, listed in the Orange Book for Novartis' Femara® tablet NDA.  The patent claims are drawn to the active pharmaceutical ingredient in letrozole tablets as well as to methods of using the drug.

With the settlement, Mylan will receive a license to market its generic version of Femara® tablets prior to the expiration of Novartis' patent in 2011.  Other details of the settlement were not released.