Lupin launches U.S. generic dasatinib tablets after FDA ANDA approval

Lupin Limited said it has launched generic dasatinib tablets in the United States following U.S. Food and Drug Administration approval of an Abbreviated New Drug Application (ANDA). The company announced the launch on February 2, 2026, saying the product was developed in partnership with Pharmascience Inc.

The tablets are offered in six strengths, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg, and are described as bioequivalent to Bristol-Myers Squibb’s Sprycel® tablets in those same strengths. Medical labeling carried in the announcement indicates the product is indicated for a range of Philadelphia chromosome-positive conditions in adults and children, including: Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Adults with chronic, accelerated, or myeloid/lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy, including imatinib. Adults with Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Pediatric patients 1 year and older with Ph+ CML in chronic phase. Pediatric patients 1 year and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Lupin cited market data that the reference listed drug Sprycel had estimated annual U.S. sales of about USD 930 million, attributing that figure to IQVIA MAT October 2025. The company positioned the launch as providing a bioequivalent alternative to the branded product, aiming to serve adults and pediatric patients treated for Ph+ CML and Ph+ ALL.

The announcement reiterated several corporate details about Lupin. Headquartered in Mumbai, the company said its products are distributed in more than 100 markets and that it operates 15 state-of-the-art manufacturing sites and seven research centres globally, with a workforce of over 24,000 professionals. Lupin also identified subsidiaries including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. Corporate trading identifiers carried in the release included BSE: 500257; NSE: LUPIN; REUTERS: LUPIN.BO; BLOOMBERG: LPCIN.

The press release and multiple news items publishing the announcement included other items from Lupin’s communications feed. One separate item on the same page referenced a pact with the TB Alliance concerning the drug Telacebec; those pieces carried executive comments unrelated to the dasatinib launch, including the statements: "By leveraging our manufacturing scale and global distribution capabilities alongside TB Alliance’s deep expertise in drug development, we aim to enable timely and equitable access to Telacebec and contribute meaningfully to the global fight against tuberculosis, leprosy, and Buruli ulcer, said Lupin Executive Director Ramesh Swaminathan said." And: "Telacebec represents the kind of scientific innovation that has the potential to transform treatment for diseases that have long been neglected," said TB Alliance President and CEO Mel Spigelman said.

The ANDA approval and launch raise several follow-up questions that were not addressed in the announcement: Lupin did not disclose pricing, who will manufacture the tablets for the U.S. market, specific distribution channels or timing of availability in pharmacies and hospitals, nor whether any patent settlements or exclusivity arrangements affect market entry. The company also did not provide a comment specific to the dasatinib launch. Reporters and analysts will likely seek clarification from Lupin, Pharmascience and market data providers about manufacturing, commercial rights, and expectations for uptake against the branded product.