Zydus Lifesciences Secures FDA Approval for Generic Leukemia Treatment, Boosting Product Portfolio
Zydus Lifesciences has received final approval from the USFDA for its generic version of Dasatinib tablets in multiple strengths. The tablets, equivalent to Bristol Myers Squibb's Sprycel®, are used to treat various forms of leukemia. They will be manufactured at Zydus's SEZ facility in Ahmedabad. The US market for Dasatinib tablets was valued at $1,807.7 million as of January 2025. This marks Zydus's 415th USFDA approval, out of 483 ANDAs filed since 2003-04.

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Zydus Lifesciences , a prominent player in the Indian pharmaceutical sector, has achieved a significant milestone with the recent approval from the United States Food and Drug Administration (USFDA) for its generic version of Dasatinib tablets. This development marks a crucial step in expanding the company's presence in the oncology market and enhancing its product offerings in the United States.
FDA Approval Details
The USFDA has granted final approval for Zydus to manufacture Dasatinib tablets in multiple strengths, including 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg. This generic version is equivalent to Bristol Myers Squibb's Sprycel®, a widely used medication for various forms of leukemia.
Therapeutic Applications
Dasatinib is indicated for the treatment of several conditions:
- Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
- Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML who have shown resistance or intolerance to prior therapy, including imatinib
- Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) who have demonstrated resistance or intolerance to prior therapy
Manufacturing and Market Potential
The approved Dasatinib tablets will be produced at Zydus Lifesciences Ltd's Special Economic Zone (SEZ) facility in Ahmedabad. This strategic manufacturing location is expected to support efficient production and distribution of the medication.
According to IQVIA data, Dasatinib tablets generated annual sales of USD 1,807.7 million in the United States as of January 2025. This substantial market size presents a significant opportunity for Zydus to capture market share with its generic offering.
Product | Annual Sales (USD) | Market | Year |
---|---|---|---|
Dasatinib tablets | 1,807.7 million | United States | January 2025 |
Regulatory Milestone
This approval represents Zydus's 415th regulatory clearance from the USFDA. The company has filed a total of 483 Abbreviated New Drug Applications (ANDAs) since the commencement of its filing process in the fiscal year 2003-04, demonstrating its consistent efforts in expanding its product portfolio and global presence.
Company's Growing Portfolio
Dr. Sharvil Patel, MD of Zydus Lifesciences, commented on another recent launch, stating, "The introduction of ANVIMO marks a new era in bone marrow transplant and kidney transplant care in India. By making this critical therapy affordable and accessible, we are reinforcing our commitment to delivering world-class healthcare solutions."
This statement, while referring to a different product, underscores Zydus's broader strategy of introducing innovative and affordable healthcare solutions to the market.
Conclusion
The USFDA approval for Dasatinib tablets represents a significant achievement for Zydus Lifesciences, potentially opening up new revenue streams and strengthening its position in the oncology market. As the company continues to expand its product portfolio and secure regulatory approvals, it remains focused on its mission of empowering people with access to quality healthcare solutions.
Historical Stock Returns for Zydus Life Science
1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
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+1.15% | -4.29% | -6.85% | -18.54% | -11.25% | +149.12% |