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Dr Reddy's Labs unveils cancer drug Lenalidomide in US

Ruchika SharmaWritten by Ruchika Sharma Published On 2022-09-08T14:47:22+05:30  |  Updated On 8 Sept 2022 2:58 PM IST
Dr Reddys Labs unveils cancer drug Lenalidomide in US
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Dr. Reddy's Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.

Hyderabad: Pharma major, Dr. Reddy's Laboratories Ltd., has recently announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules approved by U. S. Food and Drug Administration (USFDA).

With this volume-limited launch, Dr. Reddy's is eligible for first-to market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.

Lenalidomide is a thalidomide analogue indicated for the treatment of adult patients with:
• Multiple myeloma (MM), in combination with dexamethasone.
• MM, as maintenance following autologous hematopoietic stem cell transplantation (autoHSCT).
• Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.
• Mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
• Previously treated follicular lymphoma (FL), in combination with a rituximab product.
• Previously treated marginal zone lymphoma (MZL), in combination with a rituximab product

"We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories.

"Bringing a more affordable generic version to market creates greater patient access for this important drug."

Read also: Dr Reddy's Labs launches Fesoterodine Fumarate Extended-Release Tablets in US

As previously announced, Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. in settlement of all outstanding claims of its litigation. The agreed-upon percentages remain confidential.

As part of the settlement, Dr. Reddy's is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026. Dr. Reddy's Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.

Medical Dialogues team had earlier reported that Cipla Limited had also received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the USFDA.

Read also: Cipla Cancer drug Lenalidomide bags USFDA okay

Revlimid is a trademark of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.

Dr. Reddy's Laboratories Ltd. is an integrated pharmaceutical company headquartered in Hyderabad, Telangana, India. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management, and dermatology.
Dr. Reddy's operates in markets across the globe. The company's major markets include - USA, India, Russia & CIS countries, and Europe.

Read also: Dr Reddy's Labs to acquire Slayback Pharma OTC ophthalmic product rights

dr reddy's labsdr reddysUSFDALenalidomide CapsulesREVLIMIDMarc KikuchiCelgeneMultiple myelomadexamethasonemyelodysplastic syndromesMantle cell lymphomafollicular lymphomabortezomibrituximabmarginal zone lymphomacancercancer drug
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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