Global pharma major Lupin Limited has launched Dasatinib Tablets (20 mg, 50 mg, 70 mg, 80 mg, 100 mg, 140 mg) in the United States after receiving U.S. FDA approval for its Abbreviated New Drug Application (ANDA). The tablets are bioequivalent to Sprycel® (Bristol-Myers Squibb) and target Philadelphia chromosome-positive leukemia.
Lupin Limited, a leading global pharmaceutical company, announced the launch of its generic Dasatinib Tablets in the U.S. market, marking a significant milestone in its oncology portfolio. Developed in partnership with Pharmascience Inc., the product is bioequivalent to Sprycel® Tablets of Bristol-Myers Squibb, a widely prescribed cancer therapy.
Notable Updates
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Product strengths: 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg.
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Regulatory approval: U.S. FDA clearance via ANDA filing.
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Therapeutic use: Treatment of adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia (ALL).
Major Takeaways
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Launch strengthens Lupin’s oncology footprint in the U.S., one of the largest global markets for cancer drugs.
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The product offers a cost-effective alternative to Sprycel®, enhancing patient accessibility.
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Partnership with Pharmascience Inc. highlights Lupin’s collaborative approach to innovation.
Important Points
The U.S. market for Dasatinib is valued at over $1 billion annually, presenting strong growth potential.
Lupin continues to expand its specialty and generics portfolio, reinforcing its global competitiveness.
Industry analysts view this launch as a strategic move to capture market share in oncology therapeutics.
Sources: Lupin Press Release, Business Wire, The Economic Times, Pharmascience Inc.