Mylan settles with Novartis over Vivelle-Dot; Impax files for generic Fentora

US generics drugmaker Mylan (Nasdaq: MYL) says it has settled a patent litigation law suit with the US subsidiary of Swiss pharma major Novartis (NOVN: VX) related to Vivelle-Dot (estradiol transdermal system USP, twice-weekly, 0.025mg/day, 0.0375mg/day, 0.05mg/day and 0.075mg/day and 0.1mg/day), an estrogen patch to relieve symptoms of menopause.

Under the accord, pending litigation will be dismissed, and Mylan will receive a patent license to begin selling generic versions of the product on December 16, 2013, or earlier under certain circumstances. Additional details of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission, which is hostile to these so-called pay-to-delay deals.

Mylan was the first company to have filed a substantially complete Abbreviated New Drug Application containing a Paragraph IV certification with the US Food and Drug Administration for Estradiol Transdermal System USP, Twice-Weekly. This product had total US sales of $240 million for the 12 months ending September 30, 2011, according to IMS Health.