Dr. Reddy’s Laboratories announced that the US Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules.
Lenalidomide is a generic version of Revlimid (lenalidomide), offered by US-based pharmaceutical company Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.
Revlimid is an oral medication intended to treat multiple myeloma (MM), myelodysplastic syndromes (MDS), and certain anaemias.
The US FDA approved the drug in 2.5mg and 20mg strengths and granted tentative approval for 5mg, 10mg, 15mg, and 25mg strengths.
With the US FDA approval, the Indian drugmaker is eligible for 180 days of generic drug exclusivity for 2.5mg and 20mg dose formulation of Lenalidomide Capsules.
Dr. Reddy’s Laboratories North America generics CEO Marc Kikuchi said: “We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5mg and 20mg and being eligible for 180-day market exclusivity.
“We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients.”
In September last year, Dr. Reddy’s has reached a settlement agreement with Celgene to resolve the patent-related dispute between the companies.
As part of the settlement, Celgene has provided the company with a license to commercialise a limited volume of generic lenalidomide capsules in the US.
The sale of the generic cancer drug is expected to start from an undisclosed date after March 2022, after receiving regulatory approval.
Also, Dr. Reddy’s has licensed Celgene to sell generic lenalidomide capsules in the US without volume limitation starting from 31 January 2026.
The drug comes with a boxed warning of potential embryo-foetal toxicity during pregnancy, hematologic toxicity, and venous and arterial thromboembolism.
In February 2017, the US FDA has approved Celgene’s Revlimid as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.
In January 2019, Celgene has been acquired by Bristol-Myers Squibb for $74bn, said to be the world’s largest acquisition of a pharmaceutical company.
