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Bristol Myers’ leukemia blockbuster set to face generic rivals|863127-77-9|Dasatinib Monohydrate

Sprycel, or dasitinib is a kinase inhibitor used to treat chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). It was approved by the FDA in 2006. 

Sprycel, or dasitinib, is a kinase inhibitor that was approved in 2006 to treat chronic myeloid leukemia, a type of blood cancer that’s diagnosed in about 10,000 people in the U.S. each year. The tablet has been a reliable blockbuster for Bristol Myers over the years, reaching $1.9 billion in global sales in 2023. Sales topped $2.1 billion in both 2022 and 2021.

Dasatinib, also known by the brand name Sprycel, had global sales of $1.9 billion in 2023. In 2021 and 2022, sales were over $2.1 billion. 
 
The global dasatinib drugs market is expected to grow to $2,198.7 million by 2030, with a compound annual growth rate (CAGR) of 6% from 2023 to 2030. 
 
Xspray Pharma is developing a generic version of dasatinib called Dasynoc, which the company says can reduce side effects by allowing patients to take a smaller dose. The FDA reaccepted Xspray's application for Dasynoc in February 2024, and a potential launch is expected in 2024, pending FDA approval.

Pharmaceutical companies face a looming patent cliff over the next several years, as generic rivals could erode sales of some of the industry’s best-selling medicines. For some drugmakers, copycat competitors are already on the doorstep.

Bristol Myers Squibb, for one, could soon hit headwinds for its blockbuster Sprycel as the first generic of the leukemia drug is expected to hit the market in September.

Bristol Myers has faced several challenges to Sprycel’s patents, and filed a patent infringement lawsuit again Swedish biopharma company XSpray Pharma in 2022, as well as a handful of other companies that were challenging two patents listed in the Food and Drug Administration’s Orange Book that expire in 2025 and 2026.

Bristol Myers settled with XSpray last year, clearing the way for the challenger to launch a generic dasatinib as soon as Sept. 1, 2024. XSpray has an FDA decision date of July 31 for its “optimized version of dasatinib,” Dasynoc.

If Dasynoc is approved, it will join dozens of new generics cleared by the FDA this year, including several copies of cancer drugs. Their entry could lead to price declines in oncology, according to IDP Analytics. Sprycel has a list price of more than $18,000 per month. CML mostly affects adults 65 and older, and Sprycel treatment is therefore often covered under Medicare.

Biocon, Teva Pharmaceutical and several other companies also have developed dasitinib generics and secured tentative FDA approval.

Sprycel’s patent expiration isn’t the only generic threat Bristol Myers faces. Copycat competitors to Revlimid are available in limited fashion already, while protection for top-sellers Eliquis and Opdivo run out in 2026 and 2028 in the U.S., respectively.

In oncology, Bristol Myers is focused on expanding the market for Breyanzi, a CAR-T cell therapy for different types of lymphoma and leukemia, as well as for Abecma, for multiple myeloma. Opdualag, a combination immunotherapy for melanoma, also figures heavily in the company’s plans.

863127-77-9
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