Lupin launches Dasatinib Tablets in United States

02 Feb 2026 Evaluate

Lupin has launched 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 USFDA. The product was developed in partnership with Pharmascience Inc.

Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 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 are indicated for the treatment of newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the 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 the chronic phase; and 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 $930 million in the U.S. (IQVIA MAT October 2025).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.

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