Global pharma giant Lupin has strengthened its position in the American oncology market by announcing the US launch of Dasatinib tablets in multiple strengths, following FDA approval of its Abbreviated New Drug Application (ANDA). 

 

The product was developed in partnership with Pharmascience Inc.

 

Dasatinib Tablets are bioequivalent to Sprycel tablets of Bristol-Myers Squibb Company and are approved 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.

 

It's also for adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy; Pediatric patients 1 year and older with Ph+ CML in chronic phase; and Pediatric patients 1 year and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

 

Dasatinib Tablets (RLD Sprycel) had an estimated annual US sale of USD 930 million (IQVIA MAT Oct 2025), highlighting the significant market opportunity for Lupin.

 

About the launch, Lupin emphasized its commitment to global healthcare: “Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets,” the company said. “We are committed to improving patient health outcomes through our subsidiaries—Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.”

 

Pharmascience, Lupin’s development partner, is a major Canadian pharmaceutical manufacturer serving more than 50 countries worldwide.

 

“Pharmascience Inc.’s global presence and agile business development model support healthcare communities with dependable, Canadian-produced therapies designed to meet evolving patient needs,” the company said.