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Pharmaceutical companies are in crisis The looming patent cliff Over the next few years, generic competitors could take sales away from some of the industry’s best-selling drugs, and for some big drug companies, generics are already on the horizon.
Bristol-Myers Squibb could face headwinds soon as its blockbuster leukemia drug Sprycel is scheduled to become available as its first generic version in September.
Sprycel (dasatinib) is a kinase inhibitor. Approved in 2006 Used to treat chronic myeloid leukemia Blood cancer Make an impact 1 in 526 In the U.S., tablets have been a reliable blockbuster for BMS for many years, with sales expected to reach $1.9 billion by 2023, the company said in its latest report. Quarterly Update. sale Exceeded $2.1 billion In both 2022 and 2021.
BMS has faced multiple challenges to its Sprycel patents, having filed a patent infringement lawsuit against Swedish biopharmaceutical company XSpray Pharma in 2022, as well as several other companies challenging “two monohydrate patents expiring in 2025 and 2026” listed in the FDA Orange Book, the company said in a recent statement. SEC Filings.
BMS Settled with XSpray last yearIn addition to resolving all pending litigation, the deal also paves the way for XSpray to launch generic dasatinib as soon as September 1, 2024. self-invoiced The company believes its technology allows it to get around the secondary patents before they expire. The patents in question weren’t due to expire until September 28, 2026. But XSpray says:Optimized version Dasatinib Dashnok.
What is at stake?
Global sales at risk due to patent expirations by 2028
Forecast of CML treatment market size through 2028
Sprycel’s share of the CML market
If Dasynoc is approved, I’ll join. Dozens of new generics In 2024, generic drugs approved across indications, including several cancer drugs, will be launched. This wave of generics will reduce the number of branded oncology drugs available. Price drop Overall, according to IDP Analytics.
Several other pharmaceutical companies, including Biocon and Teva, are also developing generic versions of dasatinib.
The future of BMS
With patent expirations and an onslaught of generic competition looming, BMS has been warming its oncology pipeline with new candidates and also looking to expand Sprycel. Treating Pediatric Patients Developed chronic CML in 2017
The pharmaceutical giant’s cancer drug, Breyanzi, is a one-time CAR-T cell therapy. Large B-cell lymphoma approval This treatment was approved in 2022 and its use has since been expanded to include patients with relapsed or refractory disease. Mantle cell lymphomaas well Expedited Approval The FDA also granted accelerated approval to Breyanzi in May for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. Follicular lymphoma That same month, BMS faced competition in the same therapeutic area from Gilead’s Yescarta.
BMS has two early-stage candidate drugs in its pipeline for acute myeloid leukemia. AML is considered a difficult disease to treat, and the drugs, developed by Celgene and acquired by BMS when it acquired the company in 2019, are: Approved in 2017 To treat symptoms.
