Mumbai / Naples (U.S.) | Special Correspondent: Arun Sharma

Global pharmaceutical major Lupin Limited has expanded its presence in the U.S. generic drugs market with the launch of Dasatinib Tablets in multiple strengths, following approval of its Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration (US FDA).


The product has been developed in partnership with Pharmascience Inc. and marks a significant step in Lupin’s strategy to deepen its footprint in the high-value oncology segment of the American market.


Key Oncology Drug for Blood Cancer Treatment
Lupin’s Dasatinib Tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg) are bioequivalent to Sprycel®, the reference listed drug of Bristol-Myers Squibb, and are widely used in the treatment of Philadelphia chromosome-positive (Ph+) leukemias.


Approved Indications Include
The drug is indicated for the treatment of:
Newly diagnosed adults with Ph+ Chronic Myeloid Leukemia (CML) in the chronic phase
Adults with chronic, accelerated, myeloid or lymphoid blast phase Ph+ CML who show resistance or intolerance to prior therapy, including imatinib


Adults with Ph+ Acute Lymphoblastic Leukemia (ALL) resistant or intolerant to previous treatment
Pediatric patients aged one year and above with Ph+ CML in chronic phase
Pediatric patients aged one year and above with newly diagnosed Ph+ ALL, in combination with chemotherapy


Strong Market Opportunity in the U.S.
According to industry data, Sprycel® (RLD Dasatinib) recorded estimated annual sales of USD 930 million in the United States (IQVIA MAT, October 2025), highlighting the significant commercial opportunity for generic entrants.


Boost to Lupin’s Global Growth Strategy
Industry experts view the launch as a strategic milestone for Lupin, reinforcing its commitment to expanding access to affordable, high-quality cancer therapies while strengthening its global oncology portfolio.


With this approval and launch, Lupin continues to consolidate its position as a key player in complex generics and specialty pharmaceuticals, particularly in regulated markets such as the United States.


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