FDA Reveals First Generic Challenge to Celgene’s Cancer Drug Revlimid

The FDA has received an ANDA to market a generic version of Revlimid 25 mg, the first challenge to Celgene’s blockbuster cancer drug. While the agency acknowledged receiving the Revlimid (lenalidomide) ANDA last month, along with a Paragraph IV certification challenging Celgene’s patents, it did not disclose the name of the ANDA filer. Celgene said it will respond with legal action if it receives a Paragraph IV notification letter. If Revlimid were to lose its patent protection, it would be a blow to the company as the drug brought in about $1.7 billion in worldwide sales last year, more than half of Celgene’s total revenue.
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