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PARSIPPANY, N.J. — Actavis Inc. has relaunched its Vestura oral contraceptive in the wake of a favorable court decision.
The company said late Tuesday that it has released Vestura (3 mg drospirenone and 0.02 mg ethinyl estradiol) — a generic version of Bayer HealthCare Pharmaceuticals’ Yaz oral contraceptive — after a U.S. Court of Appeals for the Federal Circuit ruling that U.S. Patent No. RE 37,564 is invalid.
Actavis said it initially launched Vestura in January 2012 but pulled the product from the market in March 2012 following a ruling from the U.S. District Court for the District of Nevada upholding the validity of the RE ‘564 Patent. Actavis appealed the ruling to the Federal Circuit.
Vestura is indicated for the prevention of pregnancy and for the treatment of moderate acne in women at least 14 years old, only if the patient desires an oral contraceptive for birth control, according to Actavis.
Total U.S. branded and generic sales of Yaz were about $347 million for the 12 months ended Feb. 28, Actavis reported.
