FDA Approves Generic Lenalidomide Capsules in Multiple Strengths

The FDA today approved Amneal Pharmaceuticals' generic lenalidomide capsules in multiple strengths, the company announced. Amneal will be granted a license to manufacture and sell the product, which references Celgene's Revlimid, beginning in 2026.

Amneal Pharmaceuticals' generic lenalidomide capsules were approved in multiple strengths. | wladimir1804 - stock.adobe.com

Lenalidomide, a thalidomide analogue, is indicated for the treatment of several blood cancers and myelodysplastic syndrome (MDS). Amneal's generic lenalidomide was approved in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths.

Lenalidomide (Revlimid; Celgene) was initially approved in the US in 2005, and has since been approved for the treatment of patients with multiple myeloma, anemia due to MDS, relapsed or progressing mantle cell lymphoma following 2 prior therapies, follicular lymphoma, and marginal zone lymphoma.2 Celgene will provide Amneal a license to the patents needed to manufacture and sell generic lenalidomide capsules in the US starting January 31, 2026, according to the press release.1

In the press release, Amneal also announced the launch of mesalamine 800 mg delayed-release tablets referencing Asacol HD (Allergan Pharmaceuticals), which is indicated for the treatment of ulcerative colitis.1 Mesalamine is an aminosalicylate that was first approved in in 1987 for the treatment of moderately active ulcerative colitis.3 The first once-daily mesalamine, Lialda (Takeda Pharmaceuticals), was approved in 2007.4

“Our ability to execute and continuously launch complex products is expanding our portfolio of affordable medicines and driving the sustainable growth of our business,” Andy Boyer, executive vice president and chief commercial officer of affordable medicines at Amneal, said in a statement. “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.”

References

1. Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide. News release. Amneal Pharmaceuticals. February 19, 2025. Accessed February 19, 2025. https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Launches-Mesalamine-and-Receives-U.S.-FDA-Approval-for-Lenalidomide/default.aspx

2. Revlimid. Prescribing information. Bristol Myers Squibb; 2023. Accessed February 19, 2025. https://packageinserts.bms.com/pi/pi_revlimid.pdf

3. Asacol HD. Prescribing information. Allergan; 2021. Accessed February 19, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021830s019lbl.pdf

4. FDA approves Lialda (mesalamine), the first oral once-daily mesalamine for patients with active, mild to moderate ulcerative colitis. January 16, 2007. Accessed February 19, 2025. https://www.drugs.com/newdrugs/fda-approves-lialda-mesalamine-first-oral-once-daily-mesalamine-patients-active-mild-moderate-317.html