Lupin Limited has launched Dasatinib Tablets in the United States, available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg dosages. The launch follows FDA approval and the product is bioequivalent to Sprycel®. Dasatinib Tablets are indicated for treating certain types of leukemia in adult and pediatric patients. Sprycel® had estimated annual sales of USD 930 million in the U.S.
Dasatinib Tablets Now Available
Lupin Limited announced the launch of Dasatinib Tablets in the U.S. market on February 02, 2026. The tablets are available in multiple strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
Bioequivalent to Sprycel®
Dasatinib Tablets are bioequivalent to Sprycel®, which is marketed by Bristol-Myers Squibb Company. The available strengths mirror those of the reference product (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg).
Therapeutic Indications
Dasatinib Tablets are 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.
Market Opportunity
According to IQVIA data from October 2025, Dasatinib Tablets (Sprycel®) had an estimated annual sale of USD 930 million in the U.S.
Source: BSE
