Actavis plc (NYSE: ACT) today confirmed that its subsidiary, Warner Chilcott Company LLC, has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (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 NuvaRing®, which is an estrogen/progestin combination hormonal contraceptive indicated for use by women to prevent pregnancy.
Merck Sharp & Dohme B.V. filed suit against Warner Chilcott on December 24, 2013, in the U.S. District Court for the District of Delaware seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of U.S. Patent No 5,989,581. 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.
Based on available information, 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 approximately $560 million, according to IMS Health data.
