FDAnews Drug Daily Bulletin


Dec. 12, 2005

Barr Pharmaceuticals has finalized an agreement with Organon and Savient Pharmaceuticals to acquire the exclusive rights to the oral contraceptive Mircette.

Under the terms of the deal, which was first announced in September, Organon and Savient have agreed to sell Barr the rights to Mircette (desogestrel/ethinyl estradiol) and terminate their ongoing patent litigation regarding Barr's generic version of the contraceptive drug. Barr plans to promote Mircette through its Duramed Pharmaceuticals subsidiary, which recently expanded its specialty sales force.

The agreement ends a drawn out patent dispute that had bounced from district court to appeals court and back since 2001. Savient and Organon first sued Duramed Pharmaceuticals, which originally applied to market generic Mircette, but Barr became the target of the suit after acquiring Duramed. The U.S. District Court for the District of New Jersey originally ruled in favor of Barr in 2001, but the U.S. Court of Appeals for the Federal Circuit sent the case back to the lower court for further review in 2003.