PRINCETON, N.J. — September 23, 2026

ANI Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths. The approved product is the generic version of Afinitor Disperz®, a reference listed drug. ANI said the approval expands its U.S. generics portfolio and represents another technically demanding formulation developed by its research and development organization.

Everolimus Oral Suspension Expands Generic Portfolio

ANI’s Everolimus Tablets for Oral Suspension are approved in three dosage strengths: 2 mg, 3 mg and 5 mg. The product is designed as a generic equivalent to Afinitor Disperz® and adds another specialized formulation to ANI’s U.S.-focused generics business. The company said its generics strategy continues to emphasize complex formulations supported by its research and development capabilities and U.S.-based manufacturing operations.

Everolimus Market Supports Commercial Opportunity

U.S. annual sales for Everolimus Tablets for Oral Suspension were approximately $123 million based on July 2026 moving annual total IQVIA data, according to ANI. The company expects the approval to contribute to the continued expansion of its commercial product portfolio. ANI has also stated that it remains on track to launch at least 15 new generic products during 2026, supporting its broader strategy of increasing the number of products in its U.S. generics business.

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ANI Advances U.S. Generics and Specialty Portfolio

The Everolimus approval adds to ANI’s diversified portfolio spanning generics, rare disease and branded therapeutics. The company’s Rare Disease business markets products across areas including ophthalmology, rheumatology, nephrology, neurology and pulmonology, while its Generics business focuses on research, development, manufacturing and commercialization of pharmaceutical products in the United States. The latest FDA approval further expands ANI’s generic product offerings while supporting its ongoing commercial growth strategy.

Source :ANI Pharmaceuticals, press release