When Bristol Myers Squibb agreed to buy Celgene for $74 billion last year, analysts wondered if it was worth the price—and they specifically called out patent challenges to Celgene's top-selling cancer drug Revlimid.
Since then, legal settlements and decisions have lifted some of that uncertainly. And with a new settlement, Bristol has an even better read on Revlimid's looming generics assault.
BMS said Thursday it had inked a patent settlement with Dr. Reddy’s Laboratories, allowing the Indian generics company to start with a “volume-limited” launch sometime after March 2022. The exact date of the rollout, and amount of generic Revlimid Dr. Reddy’s will be allowed to sell, are confidential. But on January 31, 2026, the company will have a license to sell its generic Revlimid with no limits.
The deal follows a separate agreement, struck by Celgene, that allows India's Natco Pharma to start with a limited generic launch in March 2022. That agreement allows Natco to start selling “mid-single-digit percentages” of Revlimid’s total volume that month, with the figure gradually increasing over time to up to one-third of Revlimid's numbers.
In a third agreement, inked last year, Alvogen will be able to sell generics up to single-digit percentages of Revlimid volumes sometime after March 2022. Alvogen has already launched a Revlimid generic in some European countries.
All three companies can roll out unlimited generics in the U.S. on January 31, 2026.
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Used to treat myelodysplastic syndromes, multiple myeloma and mantle cell lymphoma, Revlimid is a pricey treatment that pulled in $5.8 billion in the first half of 2020 alone. The drug has faced patent challenges before, but it scored a big win against Dr. Reddy’s back in February 2019, when the U.S. Patent & Trademark Office refused to invalidate three patents.
At the time, Credit Suisse Analyst Vamil Divan wrote that the PTO’s decision would allow Celgene and BMS to strike a favorable settlement with Dr. Reddy's Laboratories. Analysts figured the decision would allow Revlimid to steer clear of generics until at least 2023.
RELATED: The BMS-Celgene merger’s Achilles heel? An earlier-than-expected Revlimid patent loss
Questions around Revlimid’s patent risks were front and center immediately after BMS inked the $74 billion buyout in early 2019.
At a Q&A session with management, longtime biotech analyst Tim Anderson pointed out investor concerns about Revlimid and its exclusive hold on the market, but Bristol CEO Giovanni Caforio said his company was interested in much more than the blood cancer medicine. With Celgene, BMS also picked up six near-term launches, including two CAR-T treatments for cancer, Caforio said.
Since the deal closed, BMS has won FDA approval for multiple sclerosis drug Zeposia, formerly known as ozanimod. But the FDA also rejected one of the Celgene CAR-T drugs, so BMS this summer said it planned to refile.