Glenmark Pharmaceuticals receives tentative ANDA approval for Norethindrone Acetate.

Glenmark Pharmaceuticals receives tentative ANDA approval for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg.

Glenmark will market this product upon receiving final approval of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg ANDA. The patent listed in the Orange Book for Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets is scheduled to expire on February 2, 2029.

According to IMS Health sales data for the 12 month period ending February 2016, the Lo Loestrin Femarket achieved annual sales of approximately $ 432.2 million.

Glenmark’s current portfolio consists of 112 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.

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