Lupin Launches Dasatinib Tablets in the United States, Estimated Annual Sale of USD 930 Million

Global pharma major Lupin Limited has announced the launch of Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States. The product was developed in partnership with Pharmascience Inc and is bioequivalent to Sprycel® Tablets of Bristol-Myers Squibb Company. The approved ANDA from the U.S. FDA indicates that the product is 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, 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 USD 930 million in the U.S. (IQVIA MAT Oct 2025).