Glenmark receives USFDA approval for generic version of ‘Lo Loestrin Fe’

Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (USFDA) 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, the generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets of Allergan Pharms Intl. According to IMS Health sales data for the 12 month period ending February 2016, the Lo Loestrin Fe market achieved annual sales of approximately $432.2 million.

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.

Glenmark’s current portfolio consists of 112 products authorized for distribution in the US marketplace and 57 ANDA’s pending approval with the USFDA. 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.