ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) has announced the FDA approval and subsequent launch of Estradiol Gel, 0.06%, a generic version of EstroGel Gel, 0.06%. This approval, following the acceptance of their Abbreviated New Drug Application (ANDA), marks a significant step in providing accessible treatment options for patients.
Nikhil Lalwani, President and Chief Executive Officer of ANI, stated, "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."
Market and Availability
The U.S. market for Estradiol Gel, 0.06% is estimated at $16.7 million annually, based on August 2024 moving annual total (MAT) IQVIA data. The introduction of a generic alternative by ANI Pharmaceuticals aims to address unmet needs by offering a cost-effective option.
About Estradiol Gel
Estradiol Gel is a medication primarily used in hormone replacement therapy (HRT) to treat symptoms of menopause, such as hot flashes, vaginal dryness, and other estrogen deficiency-related conditions. It works by supplementing the body's estrogen levels, thereby alleviating these symptoms and improving the quality of life for menopausal women.
