Lupin launches generic fertility drug Ganirelix Acetate in the US

16 Feb 2024 , 09:26 AM

The US health regulatory agency’s clearance of the pharma giant Lupin Ltd.’s launch of Ganirelix Acetate injectable for women undergoing specific reproductive procedures was announced on Thursday. According to a regulatory filing by Lupin, the US Food and Drug Administration (USFDA) approved the 250 mcg/0.5 mL single-dose prefilled syringe of Ganirelix Acetate injectable, and it has since been introduced to the US market.

It is the generic equivalent of Organon USA LLC’s Ganirelix Acetate Injection, 250 mcg/0.5 mL, which is reference listed (RLD).

The injection is recommended for women undergoing controlled ovarian hyperstimulation in order to suppress early surges of luteinizing hormone (LH).

Lupin stated that Ganirelix Acetate injection’s projected yearly sales in the US were USD 87 million, citing IQVIA MAT data from December 2023.

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