Mylan Inc., a global pharmaceutical company, along with Famy Care Ltd., has entered into a settlement agreement with Janssen Pharmaceuticals Inc. that will resolve patent litigation related to Norgestimate/Ethinyl Estradiol tablets 0.180 mg/0.025 mg, 0.215 mg/0.025 mg and 0.250 mg/0.025 mg.
Norgestimate/Ethinyl Estradiol tablets are the generic version of Janssen Pharmaceuticals Inc.'s Ortho Tri-Cyclen Lo tablets, which are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
According to the terms of the settlement, Mylan will be licensed to sell its Norgestimate/Ethinyl Estradiol tablets 0.180 mg/0.025 mg, 0.215 mg/0.025 mg and 0.250 mg/0.025 mg, on December 31, 2015, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed. All other terms and conditions of the settlement are confidential, and the agreement itself is subject to review by the US Department of Justice and the Federal Trade Commission.
Ortho Tri-Cyclen Lo tablets had US sales of $424.5 million for the 12 months ending September 30, 2012, according to IMS Health.