Lupin and Natco Gain US FDA Clearance for Eribulin Mesylate Injection

Summary:
Lupin and Natco Pharma have received U.S. FDA approval for their generic version of Eribulin Mesylate Injection, a cancer treatment equivalent to Eisai’s Halaven Injection. The drug is used to treat patients with metastatic breast cancer and unresectable or metastatic liposarcoma who have previously undergone specific chemotherapy treatments. With Halaven generating an estimated USD 43.7 million in annual U.S. sales, the approval strengthens the oncology portfolios of both companies and expands their presence in the U.S. generic pharmaceuticals market. 

Lupin Limited, in collaboration with Natco Pharma, has secured approval from the U.S. Food and Drug Administration (FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, available in 1 mg/2 mL (0.5 mg/mL) single-dose vials.

The approved generic medicine has been found therapeutically equivalent to the reference product, Halaven Injection, marketed by Eisai, and will be offered in the same dosage strength and formulation.

Eribulin Mesylate Injection is prescribed for adult patients with metastatic breast cancer who have undergone at least two prior chemotherapy treatments for metastatic disease. It is also indicated for individuals with unresectable or metastatic liposarcoma who have previously been treated with an anthracycline-based therapy.

Based on IQVIA figures for the 12-month period ending April 2026, Halaven Injection generated estimated annual U.S. sales of about USD 43.7 million.

The FDA approval further enhances the oncology product offerings of both Lupin and Natco while reinforcing their footprint in the U.S. generics market.