Patent Lawsuit of Actavis vs. Merck & Co. Over Generic Version of “NuvaRing”
A patent lawsuit has been filed against Warner Chilcott Company LLC, a subsidiary of Actavis for preventing commercialization of drug manufacturers ANDA product prior to the expiration of U.S. Patent No 5,989,581 related to an estrogen/progestin combination hormonal contraceptive “NuvaRing” that is assigned to Merck & Co.’s NuvaRing is a blockbuster drug with total U.S. sales of ~$560 million in the quarter ending October 2013.
Actavis had filed the ANDA with the U.S. Food and Drug Administration seeking approval to market Ethinyl Estradiol and Etonogestrel Vaginal Ring, 0.015 mg/24 hour and 0.12 mg/24 hour. It is a generic version of Merck & Co.’s NuvaRing, indicated for use by women to prevent pregnancy. This generic drug product, if is bioequivalent , will be approved by FDA and get listed in FDA’s Orange Book. FDA lists all the approved products, both innovator and generic in its Orange Book. Also, it will be comparable to branded product in dosage form, strength, route of administration, quality, performance characteristics and intended use.
Actavis is presumed to be the “first applicant” to file an ANDA for the generic version of NuvaRing and, should it be approved, may be entitled to 180 days of generic market exclusivity. The data furnished in an ANDA provides for the review and ultimate approval of a generic drug product. Generic drug applications are termed “abbreviated” because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
The aforementioned lawsuit was filed under the provisions of the Hatch-Waxman Act . Since 2003, this US patent law has ensured increased availability and access to generic drugs by limiting the use of 30-month stays by brand-name drug sponsors and by clarifying the types of patents that must and must not be submitted to FDA.