Originally published by our sister publication Specialty Pharmacy Continuum
- Mesalamine 800-mg delayed-release tablets, referencing Asacol HD
- Lenalidomide capsules, referencing Revlimid
Amneal Pharmaceuticals Inc., 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. The company also received approval from the FDA for its Abbreviated New Drug Application for lenalidomide capsules in 2.5-, 5-, 10-, 15-, 20- 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 United States beginning on Jan. 31, 2026. Lenalidomide, a thalidomide analog, 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, the executive vice president and chief commercial officer – affordable medicines at Amneal. “Mesalamine is a difficult-to-make product with a limited number of suppliers, and this approval highlights the strength of our R&D [research and development] capabilities.”
The most common side effects reported with mesalamine 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. For the full prescribing information, see the package insert located here.
Lenalidomide is a thalidomide analog indicated for the treatment of adult patients with multiple myeloma and transfusion-dependent anemia due to myelodysplastic syndromes. Some of the most common adverse reactions reported while lenalidomide was used include neutropenia, thrombocytopenia and leukopenia. A more comprehensive list of the most common adverse reactions reported with lenalidomide are in the full prescribing information; see the package insert located here.
According to IQVIA, U.S. annual sales for mesalamine 800 mg for the 12 months ended December 2024 were approximately $147 million.