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Mylan, Teva release generics of Ortho Tri-Cyclen Lo

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NEW YORK — Mylan N.V. and Teva Pharmaceutical Industries Ltd. have rolled out norgestimate/ethinyl estradiol tablets, a birth control pill, in the United States.

The companies said Tuesday that their products are generic versions of Janssen Pharmaceuticals Inc.’s Ortho Tri-Cyclen Lo tablets.

Mylan said its norgestimate/ethinyl estradiol tablets — available in dosages of 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg — mark the company’s 14th oral contraceptive launch in the United States.

Teva said its Tri-Lo-Sprintec norgestimate/ethinyl estradiol tablets come in a 28-day blister pack dispenser.

Mylan and Teva became licensed to market their norgestimate/ethinyl estradiol tablets as of the end of 2015 in accordance with patent litigation settlements they reached with Janssen (Ortho-McNeil-Janssen) in 2012 and 2009, respectively.

Norgestimate and ethinyl estradiol tablets totaled U.S. sales of about $488 million during the 12 months ended in September 2015, according to IMS Health data cited by Mylan and Teva.


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