-Mesalamine 800 mg delayed-release tablets, referencing ASACOL HD®
– Lenalidomide capsules, referencing REVLIMID®
BRIDGEWATER, N.J.–(BUSINESS WIRE)– Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global biopharmaceutical company, today announced the launch of mesalamine 800 mg delayed-release tablets, an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. Additionally, the Company has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths. In settlement of all outstanding claims related to this product, Celgene agreed to provide Amneal with a license to Celgene’s patents required to manufacture and sell generic lenalidomide in the U.S. beginning on January 31, 2026. Lenalidomide, a thalidomide analogue, is indicated for the treatment of several blood cancers.
Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business,” said Andy Boyer, Executive Vice President, Chief Commercial Officer – Affordable Medicines. “Mesalamine is a difficult to make product with a limited number of suppliers, and this approval highlights the strength of our R&D capabilities. Additionally, the approval of lenalidomide represents another key product approval in a large market that will be a future growth driver for us.”
The most common side effects reported with ASACOL HD® 800 mg include headache, stomach pain, burping, nausea, sore throat, dizziness, weakness, and diarrhea. Less commonly, patients have experienced chest pain, menstrual cramps, swelling in the limbs, skin rash, and worsening of colitis.
According to IQVIA® , U.S. annual sales for mesalamine 800 mg for the 12 months ended December 2024 were approximately $147 million.
