Mylan Inc, one of the leading generic and specialty pharmaceutical companies focused on respiratory, allergy and psychiatric therapies, has settled Vivelle-Dot (Estradiol Transdermal System USP, Twice-Weekly, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day and 0.075 mg/day and 0.1 mg/day) patent litigation lawsuit with Novartis Pharmaceuticals Corporation .
Pursuant to the agreement, 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.
Mylan was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the US Food and Drug Administration (FDA) for Estradiol Transdermal System USP, Twice-Weekly. This product had total US sales of $240 million for the 12 months ending Sept. 30, 2011, according to IMS Health.