FDA on Thursday approved Watson Pharmaceuticals' marketing application for its generic version of Barr Laboratories' extended-cycle oral contraceptive Seasonale, Reuters reports.
A Barr subsidiary also will launch a generic version, to be sold under the name Jolessa (Reuters, 9/7). FDA approved Seasonale, which allows users to reduce their number of annual menstrual periods from 13 to four, in September 2003.
Women take 84 active pills consecutively and then take seven placebo pills, compared with the usual regimen of 21 active pills followed by seven placebos.
The U.S. Patent and Trademark Office in May denied Barr's request to reissue its patent on Seasonale.
Barr's subsidiary Duramed Pharmaceuticals received a nonfinal rejection notice from the patent office, which gave the company three months to reply to issues raised by the government before the company's three-year product exclusivity expired on Sept. 5 (Kaiser Daily Women's Health Policy Report, 5/15).
Watson -- which in 2004 filed a marketing application with FDA saying that Duramed's Seasonale patent was unenforceable and void -- announced it will immediately launch its product, which will be sold under the name Quasense, MarketWatch reports.