Lupin Limited has launched Dasatinib Tablets in the United States, marking another significant step in expanding its oncology portfolio in the world’s largest pharmaceutical market. The launch follows the approval of Lupin’s Abbreviated New Drug Application (ANDA) by the U.S. Food and Drug Administration and has been developed in partnership with Pharmascience Inc.
The newly launched Dasatinib Tablets are available in multiple strengths 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. These tablets are bioequivalent to Sprycel® tablets marketed by Bristol-Myers Squibb Company, ensuring comparable safety, quality, and efficacy standards for patients and healthcare providers in the U.S. market.
Dasatinib is indicated for the treatment of several serious blood cancers, including newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. It is also approved for adults with chronic, accelerated, or blast phase Ph+ CML, as well as Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), particularly in cases where patients show resistance or intolerance to prior therapies. The indication further extends to pediatric patients aged one year and above for both Ph+ CML and newly diagnosed Ph+ ALL in combination with chemotherapy.
According to industry data, Dasatinib (reference listed drug Sprycel®) recorded estimated annual sales of around USD 930 million in the U.S. as of October 2025, highlighting the strong market potential of this therapy. Lupin’s entry into this segment reinforces its strategy to grow in complex generics and oncology-focused treatments.
Headquartered in Mumbai, Lupin Limited is a global pharmaceutical major with a presence in over 100 markets worldwide. The company has built a strong footprint across key therapy areas such as respiratory, cardiovascular, anti-diabetic, and central nervous system disorders, supported by 15 manufacturing facilities and seven research centers globally. With this latest launch, Lupin continues its focus on improving patient access to affordable, high-quality medicines in critical therapeutic areas.
