Lupin Launches Dasatinib in US Market in Partnership with Pharmascience
Mumbai: Global pharma major Lupin Limited has announced the launch of Dasatinib Tablets in strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg in the United States, following approval of its Abbreviated New Drug Application (ANDA) by the U.S. FDA. The product was developed in partnership with Pharmascience Inc.
The tablets are bioequivalent to Sprycel® Tablets (Bristol-Myers Squibb) and 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/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib
Adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy
Pediatric patients 1 year and older with Ph+ CML in chronic phase
Pediatric patients 1 year and older with newly diagnosed Ph+ ALL in combination with chemotherapy
Dasatinib Tablets (RLD Sprycel®) had an estimated annual U.S. sale of USD 930 million (IQVIA MAT Oct 2025).
Headquartered in Mumbai, Lupin is a global pharmaceutical leader with products in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, with strong presence in India and the U.S. across multiple therapy areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, CNS, and women’s health. Lupin operates 15 manufacturing sites and 7 research centers globally, employing over 24,000 professionals, and drives healthcare impact through subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
Headquartered in Montreal, Pharmascience Inc. is one of Canada’s largest pharmaceutical manufacturers, delivering high-quality medicines to more than 50 countries. The company’s global presence and agile development model support healthcare communities with dependable, Canadian-produced therapies designed to meet evolving patient needs.
