Glenmark Pharmaceuticals Inc., USA (Glenmark) has received final approval from the United States Food & Drug Administration (USFDA) for HAILEY 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1.5 mg/30 mcg), the generic version of Loestrin 21 1.5/30 Tablets, of Allergan Pharmaceuticals International (Allergan) and for HAILEY Fe 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 1.5 mg/30 mcg), the generic version of Loestrin Fe 1.5/30, also of Allergan.
According to IQVIA sales data for the 12 month period ending April 2018, the Loestrin 21 1.5/30 Tablets market achieved annual sales of around $24.2 million and the Loestrin Fe 1.5/30 market achieved annual sales of around $41.3 million.
Glenmark’s current portfolio consists of 137 products authorized for distribution in the US marketplace and 61 ANDAs 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.
