Actavis confirms patent challenge on Bayer's Safyral

USA-based generics major Actavis (NYSE: ACT) yesterday (June 5) confirmed that it has filed an Abbreviated New Drug Application with the Food and Drug Administration seeking approval to market drospirenone/ethinyl estradiol/levomefolate calcium and levomefolate calcium tablets, a generic version of German drug major Bayer's (BAYN: DE) Safyral, which is approved to prevent pregnancy in women who elect to use an oral contraceptive, and to provide a daily dose of folate supplementation.

Merck & Cie, Bayer Pharma AG and Bayer Healthcare Pharmaceuticals filed suit against Actavis on June 4, in the US District Court for the District of Delaware, seeking to prevent Actavis from commercializing its ANDA product prior to the expiration of US patent no 6441168 (the '168 patent). The law suit 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 Safyral and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity. For the 12 months ending April 30, 2013, Safyral had total US sales of around $19 million, according to IMS Health data quoted by Actavis.