Global pharma major Lupin Limited announced the launch of Dasatinib Tablets in the United States, a generic equivalent of Bristol-Myers Squibb’s Sprycel®. The drug, used in treating certain types of leukemia, represents a significant addition to Lupin’s oncology portfolio, tapping into a billion-dollar U.S. market.
In a major boost to its oncology offerings, Lupin Limited has officially launched Dasatinib Tablets in the United States, strengthening its presence in the world’s largest pharmaceutical market. The tablets, available in multiple strengths (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg), are the generic equivalent of Sprycel®, developed by Bristol-Myers Squibb.
Key Highlights:
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Therapeutic use: Dasatinib is prescribed for the treatment of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL), offering patients a cost-effective alternative to branded therapy.
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Market potential: Sprycel® recorded estimated annual U.S. sales of USD 1.56 billion (IQVIA MAT June 2022), underscoring the commercial significance of Lupin’s launch.
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Regulatory approval: Lupin had earlier received tentative U.S. FDA approval for its Abbreviated New Drug Application (ANDA), paving the way for this market entry.
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Strategic impact: The launch aligns with Lupin’s strategy to expand its oncology and specialty portfolio in regulated markets, enhancing accessibility to critical cancer treatments.
Outlook:
With this launch, Lupin is expected to capture a meaningful share of the U.S. oncology generics market, reinforcing its reputation as a global innovation-led pharmaceutical company.
Sources: Reuters India, Economic Times Pharma, Mint, Express Pharma