Sales of Bristol Myers Squibb’s Revlimid crescendoed at $12.8 billion in 2021, the final year of exclusivity for the multiple myeloma treatment. But now, BMS can no longer hold off generic competition.
Last month, Sandoz and Stada Arzneimittel revealed that launches of their generic versions of Revlimid are underway in Europe. Now Teva has become the first to do the same in the U.S.
Teva will provide Lenalidomide capsules in 5 mg, 10 mg, 15 mg and 25 mg strengths, it said, for the treatment of multiple myeloma in combination with dexamethasone, certain myelodysplastic syndromes and mantle cell lymphoma following specific prior treatment. The company did not note what it would charge.
“This product adds to our broad generic portfolio of oncology treatments, which accounts for 73% of the essential medicines in this category, as defined by the World Health Organization,” Christine Baeder, Teva’s SVP and chief operating officer U.S. generics, said in a statement.
Many other companies are set to launch Revlimid generics this year in the U.S., including Indian firms Natco Pharma, Sun Pharma, Zydus Cadila, Cipla and Dr. Reddy’s Laboratories.
As they brought patent challenges, these companies struck limited launch deals with BMS. Natco Pharma, for example, which gained FDA approval for its generic in May of last year, agreed to hold off its launch until this March. Then, in the first month, Natco and its U.S. marketing partner Arrow, will produce only a small amount—described as a mid-single-digit percentage of Revlimid’s monthly volume. Over time, that percentage increases, reaching 33% of Revlimid’s volume by March 2025. Then on January 31, 2026, the limitations end.
The settlements came after Revlimid’s former producer Celgene survived a patent challenge from Dr. Reddy’s. The decision allowed Celgene to extend its exclusivity and make advantageous deals with the generics makers that will help slow the erosion of Revlimid’s sales.
The introduction of generics usually puts downward pressure on prices. But limited-volume deals such as these will not impact prices as much.
BMS has projected sales of Revlimid to reach between $9.5 billion and $10 billion this year. The company then expects sales to drop between $2 billion and $2.5 billion each year afterward. With the drop in Revlimid sales, BMS sees low single-digit growth this year.
The company tried to allay investors’ fears in January when it said it had the wherewithal to sustain the loss of Revlimid revenue. Blood thinner Eliquis and immuno-oncology standouts Opdivo and Yervoy will generate added growth of $8 to $10 billion annually, CEO Giovanni Caforio said. An additional $10 to $13 billion in annual sales is expected from recent and expected launches, which include anemia drug Reblozyl, CAR-T therapy Breyanzi and psoriasis candidate deucravacitinib.