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news.Mylan along with Famy Care has signed a settlement agreement with Janssen Pharmaceuticals to 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.
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The tablets are the generic version of Janssen’s Ortho Tri-Cyclen Lo tablets to prevent pregnancy in women who use oral contraceptives.
According to the settlement agreement, the pending litigation will be dismissed and 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 from 31 December 2015 or earlier under certain circumstances.
The agreement is subject to review by the US Department of Justice and the Federal Trade Commission.
According to IMS Health, HealthOrtho Tri-Cyclen Lo tablets had sales of $424.5m for the 12 months ending 30 September 2012 in US.