New Jersey: Glenmark Pharmaceuticals Limited (Glenmark) has received final approval from the United States Food & Drug Administration (U.S. FDA) for Progesterone Vaginal Inserts, 100 mg, determined by the FDA to be bioequivalent and therapeutically equivalent1 to the reference listed drug (RLD), Endometrin®2 Vaginal Inserts, 100 mg of Ferring Pharmaceuticals Inc. [NDA 022057]. Glenmark’s Progesterone Vaginal Inserts, 100 mg will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIA® sales data for the 12-month period ending February 2026, the Endometrin® Vaginal Inserts, 100 mg market3 achieved annual sales of approximately $59.2 million*.
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.”
