Lupin Limited (BSE:500257) (NSE:LUPIN), an India-based global pharmaceutical company, announced on Monday that it has launched its Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, in the United States.

This follows US Food and Drug Administration (FDA) approval for its Abbreviated New Drug Application (ANDA).

The product, developed in collaboration with Canada-based Pharmascience Inc, is bioequivalent to Bristol-Myers Squibb's Sprycel Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.

Dasatinib Tablets are indicated for the treatment of: newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (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 leukaemia (Ph+ ALL) with resistance or intolerance to prior therapy; paediatric patients one year of age and older with Ph+ CML in chronic phase; and paediatric patients one year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Dasatinib Tablets (RLD Sprycel) had estimated annual sales of USD930m in the United States (IQVIA MAT Oct 2025).