Glenmark Pharma gets USFDA nod for progesterone inserts; eyes $59 million market

Glenmark Pharmaceuticals Ltd. on Thursday, April 9, said it has received final approval from the US Food and Drug Administration (USFDA) for its Progesterone Vaginal Inserts, 100 mg, expanding its portfolio in the women’s healthcare segment.

The approved product is bioequivalent and therapeutically equivalent to Endometrin Vaginal Inserts, a reference drug of Ferring Pharmaceuticals, the company said in an exchange filing.

Glenmark’s progesterone vaginal inserts will be marketed in the United States through its subsidiary, Glenmark Pharmaceuticals Inc., USA.

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According to IQVIA data, the Endometrin market recorded annual sales of about $59.2 million for the 12 months ending February 2026, indicating a moderate commercial opportunity.

Commenting on the development, Marc Kikuchi, President and Business Head, North America, said, "This approval for Progesterone Vaginal Inserts, 100 mg marks an important addition to our business and reinforces our focus on addressing patient needs in women’s healthcare."

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The product is typically used in women’s healthcare, particularly in fertility-related treatments.

The approval marks another addition to Glenmark’s growing portfolio of US generics as it continues to expand its presence in regulated markets.

Shares of the company were trading 0.34% down at ₹2,166.20 as of 11.49 am. The stock has delivered a 57% return over the past 12 months.