ANI Pharmaceuticals Launches Estradiol Gel, 0.06% Following FDA Approval

Key Insights

• ANI Pharmaceuticals has launched Estradiol Gel, 0.06%, after receiving final FDA approval for its Abbreviated New Drug Application, expanding its product portfolio.
• The newly launched product is a generic version of EstroGel Gel, 0.06%, providing a more affordable alternative for patients requiring estradiol therapy.
• According to IQVIA data, the U.S. annual sales for Estradiol Gel, 0.06% total approximately $16.7 million, indicating a substantial market opportunity for ANI Pharmaceuticals.

ANI Pharmaceuticals has announced the launch of Estradiol Gel, 0.06%, following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). This development allows ANI Pharmaceuticals to introduce a generic version of EstroGel Gel, 0.06%, offering a cost-effective alternative for patients.

The launch of Estradiol Gel, 0.06% represents a significant step for ANI Pharmaceuticals in expanding its product offerings. According to August 2024 moving annual total (MAT) IQVIA data, the U.S. annual sales for Estradiol Gel, 0.06% total approximately $16.7 million, highlighting the market potential for this product.