Lupin Limited has announced the launch of dasatinib tablets in multiple strengths in the United States following approval of its Abbreviated New Drug Application from the USA Food and Drug Administration. The newly launched product is available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg strengths and has been developed in partnership with Pharmascience Inc.

Dasatinib tablets from Lupin are bioequivalent to Sprycel tablets marketed by Bristol-Myers Squibb and are indicated for the treatment of a range of haematological malignancies. These include newly diagnosed adults with Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase, adults with chronic, accelerated or blast-phase Philadelphia chromosome-positive chronic myeloid leukaemia who are resistant or intolerant to prior therapies, including imatinib, and adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia with resistance or intolerance to previous treatment.

The product is also approved for use in paediatric patients aged one year and older with Philadelphia chromosome-positive chronic myeloid leukaemia in the chronic phase, as well as paediatric patients of the same age group with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia when used in combination with chemotherapy. The reference listed drug, Sprycel, recorded estimated annual sales of approximately USD 930 million in the USA, based on IQVIA data for the 12 months ending October 2025.

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with a presence in more than 100 markets worldwide. The company focuses on branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.

Pharmascience Inc., headquartered in Montreal, Canada, is one of the country’s largest pharmaceutical manufacturers and supplies high-quality medicines to over 50 countries. The company’s global reach and flexible business development model support healthcare systems with reliable, Canadian-manufactured therapies designed to address evolving patient needs.