Glenmark Pharmaceuticals Gains U.S. FDA Approval for Progesterone Inserts
Filing Summary
Glenmark Pharmaceuticals Limited has received final approval from the U.S. FDA for its Progesterone Vaginal Inserts, 100 mg. These inserts are bioequivalent and therapeutically equivalent to Endometrin® Vaginal Inserts by Ferring Pharmaceuticals Inc. The product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA. According to IQVIA® sales data, the market for Endometrin® Vaginal Inserts, 100 mg, reached approximately $59 million for the 12-month period ending February 2026. This approval adds to Glenmark’s portfolio in the U.S. market.
On April 9, 2026, Glenmark Pharmaceuticals Limited announced it has received final approval from the United States Food & Drug Administration (U.S. FDA) for its Progesterone Vaginal Inserts, 100 mg. The FDA has determined these inserts to be bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin® Vaginal Inserts, 100 mg, produced by Ferring Pharmaceuticals Inc. The approved product will be distributed in the U.S. by Glenmark Pharmaceuticals Inc., USA.
According to IQVIA® sales data, the market for Endometrin® Vaginal Inserts, 100 mg, achieved annual sales of approximately $59 million for the 12-month period ending February 2026. This data reflects the total market, including the brand and all available therapeutic equivalents. Glenmark’s product is approved for specific indications as listed in its approved label.
The approval of Progesterone Vaginal Inserts, 100 mg, marks an addition to Glenmark’s business operations in the U.S. market. The company continues to focus on expanding its portfolio in women’s healthcare, aligning with its strategy to provide quality and affordable medicines.
Glenmark Pharmaceuticals Limited is a global, research-led pharmaceutical company focused on innovation and accessibility. The company delivers a diversified portfolio across branded, innovative, generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Glenmark operates 11 manufacturing facilities and six R&D centers, with a commercial presence in over 80 countries.