Lupin launches Dasatinib tablets in United States

Lupin announced the launch of Dasatinib tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States, following the approval for its Abbreviated New Drug Application (ANDA) from the US FDA.   

Dasatinib tablets, 20 mg, 50 mg, 70 mg, 80mg, 100 mg, and 140 mg are bioequivalent to Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, of Bristol-Myers Squibb Company, and indicated for the treatment of:

• newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
• adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+CML with resistance or intolerance to prior therapy including imatinib
• adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy
• pediatric patients 1 year of age and older with Ph+ CML in chronic phase
• pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy

Dasatinib tablets (RLD Sprycel) had an estimated annual sale of USD 930 million in the US (IQVIA MAT Oct 2025).

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