Glenmark Generics announces settlement of Paragraph IV litigation with Janssen Pharmaceuticals

Glenmark Generics Inc, (GGI), the US subsidiary of Glenmark Generics Limited (GGL), announced the settlement of the litigation pending between Glenmark and Janssen Pharmaceuticals 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’s 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 US, 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 $397 million.

EP News Bureau