Glenmark Secures US FDA Approval For Progesterone Vaginal Inserts, Expands Presence In $59.2 Million Market

Glenmark Pharmaceuticals Limited has secured final approval from the U.S. Food and Drug Administration (FDA) for its Progesterone Vaginal Inserts, 100 mg. The regulatory body has confirmed that the product is both bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin Vaginal Inserts, 100 mg, originally developed by Ferring Pharmaceuticals.

The approved product will be marketed in the United States by Glenmark Pharmaceuticals Inc., USA. This approval enables Glenmark to expand its generics portfolio in the U.S. market, offering a cost-effective alternative to the branded therapy while maintaining the same safety, efficacy, and quality standards as the reference drug.

Commenting on the launch, Marc Kikuchi, President & Business Head, North America said, “At Glenmark, we remain focused on expanding access to quality and affordable medicines while continuing to strengthen our portfolio in the U.S. 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.”

According to IQVIA sales data for the 12 months ending February 2026, the market for Endometrin Vaginal Inserts, including all generic equivalents, generated approximately $59.2 million in annual sales. This highlights a significant commercial opportunity for Glenmark as it enters a well-established therapeutic segment.

It is important to note that Glenmark’s Progesterone Vaginal Inserts are approved only for the specific indications outlined in their label. The product is not intended for all uses associated with the reference drug, and its commercialisation will adhere strictly to the approved labelling.