ANI receives FDA approval for generic Everolimus

• ANI Pharmaceuticals (NASDAQ:ANIP) received final FDA approval for its generic Everolimus Tablets for Oral Suspension in 2 mg, 3 mg, and 5 mg strengths.
• The approval expands ANI’s U.S. generic drug portfolio with a formulation equivalent to Afinitor Disperz.
• ANI stated that the product supports its goal of launching at least 15 new generic products in 2026.

ANI Pharmaceuticals (NASDAQ:ANIP) received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Everolimus Tablets for Oral Suspension.

The approved product is available in 2 mg, 3 mg, and 5 mg strengths and represents the generic version of Afinitor Disperz, expanding ANI’s U.S. generics portfolio.

The company said the approval reflects continued progress by its research and development team and supports its commercial portfolio, while ANI remains on track to launch at least 15 new generic products in 2026.

Everolimus Tablets for Oral Suspension is a technically complex formulation, and the reference product generated approximately $123 million in U.S. annual sales based on July 2026 IQVIA moving annual total data.

ANI Pharmaceuticals develops and commercializes specialty pharmaceutical products, including branded and generic medicines across multiple therapeutic areas.