Glenmark receives U.S. FDA approval for Progesterone Vaginal Inserts, 100 mg, a generic version of Endometrin, targeting the $59.2 million progesterone fertility support market in the United States.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Glenmark Pharmaceuticals Limited announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for Progesterone Vaginal Inserts, 100 mg. The product was determined by the FDA to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Endometrin Vaginal Inserts, 100 mg, of Ferring Pharmaceuticals Inc. (NDA 022057).
Progesterone vaginal inserts are used for progesterone supplementation, including luteal phase support in women undergoing assisted reproductive technology (ART) procedures. Progesterone helps prepare and maintain the uterine lining to support embryo implantation and early pregnancy.
The approval was granted through the abbreviated new drug application (ANDA) pathway, which requires demonstration of bioequivalence and therapeutic equivalence to the branded reference product. Glenmark’s Progesterone Vaginal Inserts, 100 mg will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.
According to IQVIA sales data for the 12-month period ending February 2026, the Endometrin Vaginal Inserts, 100 mg market generated annual sales of approximately $59.2 million, representing an established U.S. market for progesterone supplementation therapies.
Marc Kikuchi, President and Business Head, North America, Glenmark, said the approval supports Glenmark’s strategy to expand access to quality, affordable medicines while strengthening its U.S. portfolio. He added that the progesterone vaginal inserts represent an important addition to the company’s business and reinforce its focus on addressing patient needs in women’s healthcare.
Reference
Glenmark Pharmaceuticals Receives U.S. FDA Approval for Progesterone Vaginal Inserts, 100 mg, 09 April 2026, https://glenmark.b-cdn.net/gpl_pdfs/media/Glenmark%20receives%20U.S.%20FDA%20approval%20for%20Progesterone%20Vaginal%20Inserts%20100%20mg.pdf
About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.