Actavis Confirms Generic NuvaRing Patent Lawsuit - Quick Facts

(RTTNews) - Actavis plc. (ACT) confirmed Tuesday that Merck Sharp & Dohme B.V. today filed suit against Warner Chilcott Company LLC, a subsidiary of Actavis, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing Abbreviated New Drug Application or ANDA product prior to the expiration of U.S. Patent No 5,989,581.

Actavis also confirmed that Warner Chilcott Company LLC has filed the ANDA with the U.S. Food and Drug Administration or FDA seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour.

Actavis' ANDA product is a generic version of Merck & Co.'s (MRK) NuvaRing, which is an estrogen/progestin combination hormonal contraceptive indicated for use by women to prevent pregnancy.

Actavis stated that the lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Actavis' ANDA for up to 30 months from the date the plaintiffs received notice of Actavis' ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Actavis believes it may be a "first applicant" to file an ANDA for the generic version of NuvaRing and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the 12 months ending October 31, 2013, NuvaRing had total U.S. sales of about $560 million, according to IMS Health data.