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PARSIPPANY, N.J. — Watson Pharmaceuticals Inc. is rolling out Amethia Lo tablets, an oral contraceptive.
Watson said late Wednesday that it has launched Amethia Lo (levonorgestrel/ethinyl estradiol 0.1 mg/0.02 mg) and ethinyl estradiol (0.01 mg) tablets under a settlement with Teva Women’s Health Inc.
The product is a generic equivalent of Teva’s LoSeasonique, indicated for the prevention of pregnancy.
Terms of the agreement weren’t disclosed. Watson said that as a first applicant to submit a substantially complete abbreviated new drug application (ANDA), it’s eligible for 180 days of shared generic market exclusivity.
For the 12 months ended Sept. 30, LoSeasonique had sales of about $28 million, according to IMS Health figures reported by Watson.