Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Ltd (GGL), has settled litigation with Janssen Pharmaceuticals, Inc. (Janssen) over patent actions concerning norgestimate and ethinyl estradiol tablets USP, 0.18/0.025 mg, 0.215/ 0.025 mg and 0.25/0.025 mg tablets, the generic version of Janssen Ortho Tri-Cyclen Lo tablets.
Under the terms of the settlement agreements, Glenmark will be able to market and distribute its norgestimate and ethinyl estradiol tablets USP, 0.18/0.025 mg, 0.215/ 0.025 mg and 0.25/0.025 mg tablets under a royalty bearing license from Janssen on December 31, 2015, or earlier under certain circumstances.
Janssen currently markets its product as Ortho Tri-Cyclen 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 month period ending June 2012 were approximately USD 397 million.
GGL has an established presence in North America and developing an EU presence It primarily sells its FDF products in the US and the EU, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.