Lupin launches Ganirelix acetate injection for fertility treatment in the US 

Lupin launches Ganirelix acetate injection for fertility treatment in the US 

USA – Lupin Ltd, a prominent pharmaceutical company, has announced the launch of Ganirelix Acetate injection in the United States, following approval from the US Food and Drug Administration (USFDA). 

 This injection, available in a 250 mcg/0.5 mL single-dose prefilled syringe, serves as a vital treatment option for women undergoing specific fertility treatments. 

The approval by the USFDA marks a significant milestone for Lupin, as Ganirelix Acetate injection is a generic equivalent to the reference listed drug (RLD) produced by Organon USA LLC.  

This medication is specifically indicated for inhibiting premature Luteinizing Hormone (LH) surges in women undergoing controlled ovarian hyperstimulation, thereby enhancing the efficacy of fertility treatments. 

Injection to address market demand 

According to Lupin’s regulatory filing, Ganirelix Acetate injection is expected to address a substantial market demand, with estimated annual sales of USD 87 million in the US, as per IQVIA MAT December 2023 data.  

This underscores the potential impact of the medication in meeting the needs of patients undergoing fertility treatments. 

In addition to expanding its product portfolio in the fertility treatment segment, Lupin continues to focus on innovation and development.  

The company has collaborated with CSIR-CDRI to develop a prototype formulation for an anti-fungal drug aimed at optimizing its delivery in the eye.  

This initiative reflects Lupin’s commitment to addressing unmet medical needs and improving patient outcomes through advanced research and development efforts. 

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