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03 Feb 2026
Admin
News Article

Lupin Launches Generic Dasatinib Tablets in the US After FDA ANDA Approval

Lupin Limited announced the launch of dasatinib tablets in multiple strengths in the United States following approval of its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA).

The product has been developed in partnership with Pharmascience Inc.

Available Strengths

Lupin’s dasatinib tablets are available in:

20 mg
50 mg
70 mg
80 mg
100 mg
140 mg

All strengths are bioequivalent to Sprycel (dasatinib) tablets from Bristol-Myers Squibb.

Approved Indications

Dasatinib is indicated for the treatment of:

Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in chronic phase
Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML who are resistant or intolerant to prior therapy, including imatinib
Adults with Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) resistant or intolerant to prior therapy
Paediatric patients 1 year and older with Ph+ CML in chronic phase
Paediatric patients 1 year and older with newly diagnosed Ph+ ALL in combination with chemotherapy

Expanding Access to Oncology Generics

The US launch strengthens Lupin’s oncology portfolio and supports broader access to affordable targeted therapies for blood cancers.

Dasatinib is a tyrosine kinase inhibitor (TKI) widely used in the management of CML and Ph+ ALL.

About Lupin

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India. The company markets products in over 100 countries and focuses on:

Branded and generic formulations
Complex generics
Biotechnology products
Active pharmaceutical ingredients (APIs)

About Pharmascience

Pharmascience Inc. is one of Canada’s largest pharmaceutical manufacturers, headquartered in Montreal. The company supplies high-quality medicines to 50+ countries and operates with an agile, globally focused business model.

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