Amneal launches generic Asacol HD, receives FDA nod for generic Revlimid

Amneal is introducing mesalamine 800 mg delayed-release tablets, which is a generic of Asacol HD. 

The medication is an aminosalicylate indicated for the treatment of moderately active ulcerative colitis in adults. 

Mesalamine 800 mg had a market value of roughly $147 million for the 12 months ended December 2024, per IQVIA.

[Read more: Amneal rolls out Crexont]

Additionally, Amneal has received approval from the Food and Drug Administration for lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg strengths. The medication is the generic of Revlimid. 

Revlimid is a thalidomide analogue indicated for the treatment of adult patients with multiple myeloma and transfusion-dependent anemia due to myelodysplastic syndromes. 

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, Amneal said. 

[Related: Amneal touts 39 retail, injectable product launches in 2023]

“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.”