October 11, 2022
Xiromed LLC Launches Estradiol Transdermal Gel 0.1% with a Competitive Generic Therapy (CGT) Designation

Florham Park, NJ, October 11th, 2022

Xiromed LLC, the New Jersey-based generic division of Insud Pharmaceuticals, today announced the launch of Estradiol Transdermal Gel 0.1%, generic to Divigel®.  Xiromed received final approval for its Abbreviated New Drug Application (ANDA) from the United States FDA with Competitive Generic Therapy (CGT) designation and is eligible for 180 days of CGT market exclusivity as the first generic approval to Divigel®.    

Estradiol Transdermal Gel 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.  Annual market sales for Divigel® for the twelve-month period ending July, 2022 were $45.8 million, according to IQVIA™.    

“We are excited to offer the first generic Estradiol Transdermal Gel 0.1% to patients in the US,” commented Xiromed CEO, Rob Spina.  “This launch demonstrates Xiromed’s commitment to providing quality, affordable generic healthcare products to patients.  Xiromed has established itself as a leading player in generic hormonal pharmaceuticals with a dedicated focus on women’s healthcare and this launch further bolsters our broad portfolio of women’s healthcare products.”  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/