FDA Approves ANI Pharmaceuticals' Generic Everolimus Oral Suspension
核心洞察
ANI Pharmaceuticals received final FDA approval of its ANDA for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths.
The product is a generic version of Afinitor Disperz (搜索), the reference listed drug, and adds to ANI's U.S. generics portfolio.
U.S. annual sales for everolimus tablets for oral suspension totaled approximately $123 million based on July 2026 IQVIA moving annual total data.
ANI Pharmaceuticals has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application covering Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths. The Princeton, New Jersey-based company announced the approval on Sept. 23, 2026.
The approved product is the generic version of the reference listed drug Afinitor Disperz (搜索). The oral suspension formulation is designed for patients who cannot swallow tablets, a technically demanding dosage form that ANI highlighted as evidence of its formulation capabilities.
"The FDA approval of Everolimus Tablets for Suspension is another example of our R&D team's continued execution on technically demanding formulations, and the launch adds further momentum to our commercial portfolio," said Nikhil Lalwani, President and Chief Executive Officer of ANI. "Our U.S. focused generics business continues to produce outstanding results, and we remain on track to launch at least 15 new generics this year."
Market Size and Commercial Context
U.S. annual sales for everolimus tablets for oral suspension totaled approximately $123 million, based on July 2026 moving annual total data from IQVIA.
ANI describes itself as a diversified biopharmaceutical company operating across three segments. Its Rare Disease business markets products in ophthalmology, rheumatology, nephrology, neurology and pulmonology. Its Generics business draws on R&D expertise, operational execution and U.S.-based manufacturing, while a separate Brands business completes the portfolio.
The company said the approval reflects its strategy of pursuing limited-competition products and expanding access to its products for customers and patients. ANI did not disclose a specific launch date or pricing details for the generic in the announcement.