Glenmark receives USFDA approval for generic progesterone vaginal inserts

Glenmark Pharmaceuticals on Thursday said it has received final approval from the US health regulator for its generic version of progesterone vaginal inserts used in fertility treatments.

The approval by the US Food and Drug Administration (USFDA) is for progesterone vaginal inserts of strength 100 mg, Glenmark Pharmaceuticals Ltd said in a regulatory filing.

It has been determined by the USFDA to be bioequivalent and therapeutically equivalent to the reference listed drug, Endometrin vaginal inserts, 100 mg of Ferring Pharmaceuticals Inc, it added.

Glenmark's progesterone vaginal inserts 100 mg will be distributed in the US by Glenmark Pharmaceuticals Inc, USA, the company said.

 

"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," Glenmark President & Business Head, North America, Marc Kikuchi said.

Citing IQVIA sales data for the 12 months ended February 2026, the company said Endometrin vaginal inserts, 100 mg market achieved annual sales of approximately $59.2 million.