Lupin launched Ganirelix Acetate injection in US

Lupin Ltd has launched the injection, a single-dose prefilled syringe approved by the US FDA

Lupin Ltd., a prominent pharmaceutical player, made a significant announcement on Thursday regarding the launch of Ganirelix Acetate injection in the expansive United States market. This development comes on the heels of receiving approval from the US Food and Drug Administration (USFDA) for the said product, which is specifically indicated for women undergoing certain fertility treatments. In a regulatory filing, Lupin disclosed that the Ganirelix Acetate injection is now available in the form of a single-dose prefilled syringe, boasting a potency of 250 mcg/0.5 mL. Functioning as a generic equivalent to the reference listed drug (RLD), Ganirelix Acetate Injection, 250 mcg/0.5 mL, originally developed by Organon USA LLC, this newly launched injection serves a crucial purpose in the realm of reproductive health.

Moreover, Lupin underscored the commercial significance of this launch by referencing the estimated annual sales of the Ganirelix Acetate injection in the United States. Drawing from IQVIA MAT December 2023 data, the company revealed that the product had garnered impressive sales figures amounting to USD 87 million. This strategic move by Lupin marks a significant milestone in its commitment to providing innovative and accessible healthcare solutions to women navigating the complexities of fertility treatments. With the introduction of the Ganirelix Acetate injection, Lupin aims to address an unmet medical need and enhance patient access to high-quality reproductive healthcare options in the United States market.