Lupin Limited, a global pharmaceutical company, has launched Dasatinib Tablets in the United States. These tablets come in different strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. The launch follows approval from the U.S. FDA for the Abbreviated New Drug Application (ANDA). The product was developed in partnership with Pharmascience Inc.
The Dasatinib Tablets are equivalent to Sprycel® Tablets from Bristol-Myers Squibb and are used to treat:
- Adults newly diagnosed with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.
- Adults with CML who are resistant to or unable to tolerate previous treatments, including imatinib.
- Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior treatment.
- Children aged 1 and older with Ph+ CML in the chronic phase.
- Children aged 1 and older with newly diagnosed Ph+ ALL, in combination with chemotherapy.
Dasatinib Tablets (which are bioequivalent to Sprycel®) had an estimated annual sales of USD 930 million in the U.S. in October 2025.
Lupin is a leading global pharmaceutical company based in Mumbai, India. The company is known for its broad range of products, including branded and generic medicines, complex generics, biotechnology products, as well as active pharmaceutical ingredients. Lupin has a strong prominence in over 100 countries and specializes in areas like respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, women’s health, etc.
The company operates 15 manufacturing sites as well as 7 research centers worldwide, with over 24,000 employees. Through its subsidiaries, such as Lupin Diagnostics, Lupin Digital Health, as well as Lupin Manufacturing Solutions, Lupin is committed to improving patient health outcomes.