Merck & Co. (MRK) sued Actavis Plc’s Warner Chilcott unit seeking to block sales of a generic version of NuvaRing, a contraceptive with estimated annual sales of more than $664 million.
Warner Chilcott is accused of trying to market the generic before the expiration of Whitehouse Station, New Jersey-based Merck’s patent in 2018, according to the complaint filed today in federal court in Delaware.
Actavis, which has global headquarters in Dublin, said in a statement that it may be the first company to file a new drug application with the U.S. Food and Drug Administration for generic versions of the contraceptive.
NuvaRing is a combined hormonal vaginal contraceptive ring that includes both estrogen and progestin to prevent pregnancy. The product, which was linked in a 2011 FDA report to a higher risk for blood clot complications, had third-quarter sales of $170 million. NuvaRing is expected to generate $664.2 million in sales this year, according to the average of six analysts’ estimates compiled by Bloomberg.
Actavis (ACT), the largest U.S. maker of generic drugs, said Merck’s lawsuit would halt final FDA approval of its application for as long as 30 months or until a final resolution in court. If the application is approved, Actavis as a “first applicant” may be entitled to 180 days of generic market exclusivity, the company said in its statement.
Merck rose 5 cents to $49.41 at the close in New York. The shares have gained 21 percent this year.
The case is Merck Sharp & Dohme BV v. Warner Chilcott Co., U.S. District Court, District of Delaware (Wilmington).
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