Natco Pharma and Lupin Get US FDA Approval for Eribulin Mesylate Injection
Natco Pharma and Lupin announced U.S. FDA approval for Eribulin Mesylate Injection, 1 mg/2ml. This drug is bioequivalent to Halaven® Injection, which had estimated U.S. sales of USD 43.7 million in April 2026. The injection is used for metastatic breast cancer and liposarcoma.
The approval of a drug with significant past sales indicates a positive market opportunity, but the impact is medium as it's an alliance and the exact market share gain is yet to be determined.
The U.S. FDA approval for a new drug product is a positive development for the company, potentially leading to increased revenue and market presence.
Natco Pharma Limited (NATCO), in alliance with Lupin Limited, announced on June 3rd, 2026, the approval from the United States Food and Drug Administration (U.S. FDA) for NATCO's Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2ml (0.5 mg/ml) Single-Dose Vials.
This approved Eribulin Mesylate Injection is bioequivalent to the reference listed drug, Halaven® Injection, manufactured by Eisai, Inc. The drug is indicated for the treatment of adults with metastatic breast cancer who have undergone at least two prior chemotherapy regimens for metastatic disease, and for unresectable or metastatic liposarcoma patients who have previously received an anthracycline-containing regimen.
Eribulin Mesylate Injection (RLD Halaven®) had reported estimated annual sales of USD 43.7 million in the U.S. as of April 2026 (IQVIA MAT April 2026). NATCO Pharma Limited, headquartered in Hyderabad, India, is a research and development-driven pharmaceutical company specializing in generic and specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products, with a focus on limited competition molecules in the U.S. market.
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Natco Pharma Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it medium impact: worth reading, rarely worth acting on by itself.
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See the model portfoliosA plain-language summary of a public exchange filing by Natco Pharma Limited. Read the original for the full detail.