Dr Reddy’s Eyes Generic Revlimid Exclusivity With ANDA Approval
Follows Natco ANDA Approval Earlier This Year; Market To Form In Months
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.
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Teva has bolstered its oncology offering in the US by moving first on one of the largest small-molecule opportunities in the US: Bristol Myers Squibb’s multi-billion-dollar blockbuster Revlimid (lenalidomide) to treat multiple myeloma.
This month, generic competition to several lucrative brands, not least Bristol Myers Squibb’s $8.7bn Revlimid, are set to fall to generic competition in the US. Meanwhile, Sawai is looking to close on a key deal.
Australia’s Federal Court has ordered Dr Reddy’s to provide Celgene with three months written notice that it intends to bring a generic lenalidomide Revlimid rival to market.