Lupin Limited, a global pharmaceutical company, has announced the launch of Dasatinib Tablets in the United States after receiving approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).

The newly launched product is available in six strengths—20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg—and has been developed in partnership with Pharmascience Inc.

Lupin’s Dasatinib Tablets are bioequivalent to Sprycel® Tablets, marketed by Bristol-Myers Squibb, and are indicated for the treatment of several hematologic malignancies. These include newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase, as well as adults with chronic, accelerated, or blast-phase Ph+ CML who are resistant or intolerant to prior therapies, including imatinib. The drug is also approved for adults with Ph+ acute lymphoblastic leukemia (ALL) who have shown resistance or intolerance to previous treatments.

In addition, the product is indicated for pediatric patients aged one year and older with Ph+ CML in the chronic phase, and for pediatric patients with newly diagnosed Ph+ ALL when used in combination with chemotherapy.

According to IQVIA data (MAT October 2025), Sprycel® recorded estimated annual sales of approximately USD 930 million in the U.S., highlighting the significant market opportunity for the generic version.

The launch further strengthens Lupin’s oncology portfolio in the U.S. and underscores its focus on expanding access to affordable treatment options for patients with cancer.