ANI Pharmaceuticals Launches FDA-Approved Estradiol Gel, 0.06%

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) announced the FDA approval and commercial launch of its Estradiol Gel, 0.06%, a generic equivalent of EstroGel® Gel, 0.06%. This marks ANI’s latest release in a market with limited competition, providing patients and healthcare providers with increased access to this estrogen therapy.

The U.S. market for Estradiol Gel, 0.06% generates approximately $16.7 million in annual sales, according to recent IQVIA data. Nikhil Lalwani, ANI’s President and CEO, emphasized the company’s commitment to offering high-quality, accessible products: “With the FDA approval and commercialization of Estradiol Gel, 0.06%, we are pleased to bring another limited-competition product to market and ensure that customers and patients in need have ready access.”

About ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) is a diversified biopharmaceutical company serving patients in need by developing, manufacturing, and marketing high-quality branded and generic prescription pharmaceutical products, including for diseases with high unmet medical need. The Company is focused on delivering sustainable growth by scaling up its Rare Disease business through its lead asset Purified Cortrophin® Gel, strengthening its Generics business with enhanced research and development capabilities, delivering innovation in Established Brands, and leveraging its U.S. based manufacturing footprint.

 

 

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ANI Pharmaceuticals Launches FDA-Approved Estradiol Gel, 0.06%

Alex Corbit