Glenmark Gets FDA Approval for Bioequivalent Progesterone Vaginal Insert

Glenmark Pharmaceuticals has final approval from the U.S. FDA for its progesterone vaginal inserts in 100-mg dose. The FDA determined the inserts are bioequivalent, as well as therapeutically equivalent, to the reference listed drug. That drug, known by the brand name Endometrin, is made by Ferring Pharmaceuticals. It too is available in 100-mg dose.

FDA Defines Progesterone Purpose

The FDA prescribing information for the Ferring reference drug says it supports “embryo implantation and early pregnancy.” It is administered as part of an Assisted Reproductive Technology treatment program for women with infertility challenges.

For the 12-month period ending February 2026, IQVIA sales data reported that Ferring’s Endometrin brought in approximately $59.2 million.

Marc Kikuchi, Glenmark President & Business Head, North America, says the bioequivalent inserts’ launch reinforces a focus on women’s healthcare.

“This approval for progesterone vaginal inserts, 100 mg marks an important addition to our business,” Kikuchi said. “We remain focused on expanding access to quality and affordable medicines while continuing to strengthen our portfolio in the U.S.”

Glenmark’s U.S. and Other Interests

Glenmark Pharmaceuticals USA, based in Elmwood Park, NJ, will assume responsibility for distributing the bioequivalent inserts in the U.S.

Also on April 9, Glenmark announced the start of distribution for its generic version of GSK‘s Flovent (fluticasone propionate inhaler). The FDA approved Glenmark’s treatment on March 4, 2026.

Headquartered in India, Glenmark operates 11 manufacturing facilities and six R&D centers on four continents. The company says its commercial footprint extends to more than 80 countries. Its portfolio encompasses branded, innovative, generics, and consumer health products in the respiratory, dermatology, and oncology spaces.