Press Release
Florham Park, NJ, September 30th, 2025
Xiromed LLC today announced the launch of Progesterone Vaginal Insert, 100 mg, generic to Endometrin®. Xiromed’s Abbreviated New Drug Application (ANDA) approval is the first generic approved by the U.S. Food and Drug Administration (FDA) with a Competitive Generic Therapy (CGT) designation and is eligible for 180-day CGT market exclusivity. Progesterone Vaginal Insert is a progesterone indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Rob Spina, CEO of Xiromed LLC commented, “As a leader in the Women’s Health space globally and in the US, the approval of Xiromed’s Progesterone Vaginal Insert demonstrates our continued commitment to providing affordable therapeutic options for women in all phases of life. Infertility is a therapeutic area that still presents many barriers to access and affordability and is a key area of focus for Xiromed. We are dedicated to increasing access to quality, affordable options for women and families in need of ART treatment and reducing barriers to conception by increasing the availability of these medicines critical to overcoming infertility. This CGT approval further demonstrates our commitment to expanding access to pharmaceutical products that previously lacked affordable generic options.”
Annual market sales for Endometrin for the twelve-month period ending July, 2025 were $50.1 million, according to IQVIA™.
Xiromed LLC, located in Florham Park, NJ, is the US generic division of Insud Pharma, S.L., a global pharmaceutical group headquartered in Madrid, Spain. Xiromed is focused on developing and commercializing high quality generic pharmaceutical products for the US market. In addition to its commercial portfolio of generics available in the US, Xiromed has a robust development portfolio of generic pharmaceutical products in various stages of development, including injectable, inhalation and complex generic products. Learn more at http://www.xiromed.com/usa/
