Amneal Pharmaceuticals has received U.S. Food and Drug Administration approval for lenalidomide capsules and will enter the U.S. generic lenalidomide market in 2026 under a settlement agreement with Celgene.
The company has launched mesalamine 800-mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adult patients and has received U.S. Food and Drug Administration (FDA) approval for lenalidomide capsules in multiple strengths, according to a press release from Amneal Pharmaceuticals. The formulation references ASACOL HD and enters the U.S. mesalamine market. The company has also received U.S. FDA approval for its Abbreviated New Drug Application for lenalidomide capsules in 2.5-mg, 5-mg, 10-mg, 15-mg, 20-mg, and 25-mg strengths, referencing REVLIMID. Lenalidomide, a thalidomide analogue, is approved for the treatment of multiple myeloma and transfusion-dependent anemia caused by myelodysplastic syndromes.
As part of a settlement agreement, Celgene has granted Amneal Pharmaceuticals a license to manufacture and market generic lenalidomide in the United States beginning on January 31, 2026, resolving outstanding patent litigation. Andy Boyer, Executive Vice President and Chief Commercial Officer–Affordable Medicines, stated that these regulatory milestones reflect Amneal’s ongoing efforts to expand its portfolio of complex generics and support its business growth.
The safety profile of mesalamine 800-mg delayed-release tablets is consistent with its class. Reported adverse effects include headache, abdominal pain, eructation, nausea, pharyngitis, dizziness, fatigue, and diarrhea. Less frequently observed adverse effects include chest pain, dysmenorrhea, peripheral edema, cutaneous reactions, and exacerbation of colitis.
Common adverse effects of lenalidomide include neutropenia, thrombocytopenia, and leukopenia.
According to IQVIA, U.S. sales for mesalamine 800 mg were approximately $147 million in the 12 months ending December 2024. With the mesalamine market entry and the anticipated lenalidomide launch in 2026, additional generic treatment options may become available.
