Dr Reddy’s Labs announces limited volume US launch of Lenalidomide Capsules

Dr Reddy’s Laboratories said that it has launched two of six strengths of cancer medication Lenalidomide Capsules, a generic of Revlimid, which has been approved by the US Food and Drug Administration (FDA).

The Indian pharma company is entitled to first-to-market, 180 days of generic drug exclusivity for the product in 2.5mg and 20mg strengths which will see a limited volume launch.

Marc Kikuchi – Dr. Reddy’s Laboratories North America Generics CEO said: “We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity. Bringing a more affordable generic version to market creates greater patient access for this important drug.”

Dr Reddy’s Labs announces limited volume US launch of Lenalidomide Capsules. Photo courtesy of Arichuvadi/Wikimedia Commons.

As per a previous announcement made by Dr. Reddy’s Laboratories, Celgene agreed to provide a license to the Indian pharma company to sell volume-limited quantities of generic lenalidomide capsules in the US. This is in settlement of all outstanding claims of Celgene’s litigation.

The agreed-upon percentages have not been revealed by Dr Reddy’s Laboratories. Under the terms of the settlement, the Indian pharma major is also permitted to sell generic lenalidomide capsules in the US without volume limitation starting from 31 January 2026.

Dr. Reddy’s Laboratories Lenalidomide Capsules are available in 2.5mg, 5mg, and 10mg, each in a bottle-count size of 28, while the 15mg, 20mg, and 25mg strengths will come in bottle-count sizes of 21.