Glenmark Secures USFDA Nod for Progesterone Vaginal Inserts, Targets USD 59 Million US Market
New Delhi: Glenmark Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for its Progesterone Vaginal Inserts, 100 mg, which are therapeutically and bioequivalent to the reference listed drug Endometrin, 100 mg, with the product set to be marketed in the United States through Glenmark Pharmaceuticals Inc., USA, targeting a market with annual sales of about USD 59.2 million.
The approved product is a generic version of Endometrin Vaginal Inserts, 100 mg, originally developed by Ferring Pharmaceuticals Inc. The USFDA has confirmed that Glenmark’s product meets the required standards of bioequivalence and therapeutic equivalence.
According to IQVIA data for the 12-month period ending February 2026, the Endometrin Vaginal Inserts market recorded annual sales of approximately $59.2 million, indicating a significant commercial opportunity for Glenmark in the US market.
Commenting on the development, Marc Kikuchi, President and Business Head, North America, stated that the approval marks an important addition to the company’s portfolio and reflects its continued focus on expanding access to high-quality and affordable medicines, particularly in the women’s healthcare segment.
The company noted that the approved product will be marketed only for the indications listed in its approved label and not for all indications of the reference listed drug.
Glenmark Pharmaceuticals is a global, research-driven pharmaceutical company with a presence in over 80 countries. It operates 11 manufacturing facilities across four continents and is supported by six R&D centres. The company has a diversified portfolio spanning branded, generics, innovative, and consumer healthcare products, with key focus areas including respiratory, dermatology, and oncology.
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