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Dr Reddy’s Eyes Generic Revlimid Exclusivity With ANDA Approval

Follows Natco ANDA Approval Earlier This Year; Market To Form In Months

 
• By Dean Rudge

With Natco poised to debut the first batch of Revlimid generics in the US in March next year, fellow Indian ANDA sponsor Dr Reddy’s Laboratories has secured its own approval from the FDA for two strengths of the blockbuster multiple myeloma treatment.

Firms Await Regulatory Inspections
BMS anticipates 'more of a slope than a cliff' • Source: Alamy

Dr. Reddy’s Laboratories is claiming eligibility for 180 days of market exclusivity for two strengths of generic Revlimid (lenalidomide) with a US Food and Drug Administration approval, after Natco Pharma and partners Arrow and Teva bagged the first generic approval earlier this year for the blockbuster treatment for multiple myeloma.

The Indian firm has obtained final approval for its abbreviated new drug application referencing Revlimid capsules in 2

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