Glenmark Generics’ US arm settles litigation with Janseen for launching Ortho Tricyclen LO tablets

06 Nov 2012 Evaluate

Glenmark Generics’ United States subsidiary, Glenmark Generics Inc, USA (GGI), has settled its litigation between Glenmark and Janseen Pharmaceuticals Inc (Janseen) over patent actions concerning Norgestimate and Ethinyl Estradiol Tablets USP, 0.18/0.25 mg, 0.215/0.025 mg and 0.25/0.025 mg tablets, the generic versions of Janssen Ortho Tricyclen LO tablets.

Under the settlement agreements, the company will be able to market and distribute Norgestimate and Ethinyl Estradiol USP, 0.18/0.25 mg, 0.215/0.025 mg and 0.25/0.025 mg tablets under a royalty bearing license from Janssen on December 1 2015, or earlier under certain circumstance.

Janseen currently markets its products as Ortho Tricyclen LO in the United States, indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Total US sales as reported by IMS Health for the 12 months period ending June 2012 were approximately $ 397 million.

Glenmark Generics (GGL) is a subsidiary of Glenmark Pharmaceuticals and aims to be a global integrated Generic and API leader. GGL has an established presence in North America and developing an EU presence. It primarily sells FDF products in the United States and the European Union, as well as its oncology FDF products in South America.

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