Actavis subsidiary seeks approval for generic version of NuvaRing

Merck, partnering company file suit against Warner Chilcott over FDA filing

DUBLIN — Actavis said it was likely the first company to file with the Food and Drug Administration for approval of a generic version of a contraceptive device made by Merck, the generic drug maker said Tuesday.

Actavis said Warner Chilcott, now one of its subsidiaries, had filed with the FDA for approval of the ethinyl estradiol and etonogestrel vaginal ring in the 0.015-mg-per-day and 0.12-mg-per-day strengths. The device is a generic version of Merck's NuvaRing.

In response to the filing, Merck and Dohme B.V. filed a patent-infringement lawsuit against Warner Chilcott Tuesday in the U.S. District Court for the District of Delaware in an effort to prevent the generic product from being marketed; the lawsuit puts an automatic stay of FDA approval on the generic for 30 months, unless the companies settle the matter sooner.

NuvaRing had sales of about $560 million during the 12-month period that ended in October, according to IMS Health.

 

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