Global pharmaceutical major Lupin Limited has launched Dasatinib Tablets in multiple strengths in the United States following approval of its Abbreviated New Drug Application (ANDA) by the US Food and Drug Administration (USFDA). The product has been developed in partnership with Pharmascience Inc.
The newly launched Dasatinib Tablets are available in 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg strengths. The formulation is bioequivalent to Sprycel® Tablets, the reference listed drug marketed by Bristol-Myers Squibb Company.
Dasatinib is indicated for the treatment of several hematological malignancies, including Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) across chronic, accelerated, and blast phases in adults who are newly diagnosed or resistant or intolerant to prior therapies such as imatinib.
It is also approved for use in adults with Ph+ acute lymphoblastic leukemia (ALL) who show resistance or intolerance to previous treatment. In the pediatric population, the drug is indicated for patients aged one year and above with Ph+ CML in the chronic phase, as well as newly diagnosed Ph+ ALL in combination with chemotherapy.
According to IQVIA data (MAT October 2025), the reference product Sprycel® recorded estimated annual sales of USD 930 million in the US, highlighting the commercial significance of the launch.
The US launch of generic Dasatinib further strengthens Lupin’s oncology portfolio and underscores its focus on expanding access to high-value, complex therapies in key global markets while reinforcing its presence in the US generics space.
