Lupin Launches Dasatinib Tablets in U.S. Market
Filing Summary
Lupin Limited has launched Dasatinib Tablets in the United States, following approval from the U.S. FDA for its Abbreviated New Drug Application. The tablets, available in multiple dosages, are bioequivalent to Sprycel® Tablets by Bristol-Myers Squibb. The product is indicated for various forms of Philadelphia chromosome-positive leukemia in adults and pediatric patients. The estimated annual sales for the reference drug in the U.S. were USD 930 million as of October 2025. This launch was developed in partnership with Pharmascience Inc., a major Canadian pharmaceutical manufacturer.
Lupin Limited has announced the launch of Dasatinib Tablets in the United States, effective February 2, 2026. This follows the approval of its Abbreviated New Drug Application (ANDA) by the U.S. FDA. The tablets are available in dosages of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
The Dasatinib Tablets are bioequivalent to Sprycel® Tablets, a product of Bristol-Myers Squibb Company. They are indicated for the treatment of adults with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. Additionally, they are indicated for adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+CML who have shown resistance or intolerance to prior therapy, including imatinib. The tablets are also indicated for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
For pediatric patients aged one year and older, the tablets are indicated for Ph+ CML in the chronic phase and newly diagnosed Ph+ ALL in combination with chemotherapy. The reference drug, Sprycel®, had an estimated annual sale of USD 930 million in the U.S. as of October 2025, according to IQVIA MAT data.
The development of Dasatinib Tablets was conducted in partnership with Pharmascience Inc., a leading pharmaceutical manufacturer based in Canada. Pharmascience delivers high-quality medicines to over 50 countries and supports healthcare communities with Canadian-produced therapies.
Lupin Limited is a global pharmaceutical leader with a presence in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin operates 15 manufacturing sites and 7 research centers globally, focusing on improving patient health outcomes through its subsidiaries, including Lupin Diagnostics and Lupin Digital Health.