Glenmark, Evestra’s partnership to develop, commercialize generic NuvaRing

Glenmark Pharmaceuticals, USA, and Evestra, have completed a strategic development, license and commercialization agreement to develop and market a generic version of Merck’s & Co.’s NuvaRing product – etonogestrel/ethinyl estradiol vaginal ring – designed to allow women access to a more affordable birth control option.

Development on the vaginal ring product is currently under way and the two companies expect to file an Abbreviated New Drug Application (ANDA) in fiscal 2019. Evestra will develop this product exclusively for Glenmark for the US market, and will receive certain milestone payments during various stages of the product’s development, including royalties on net sales.

Glenmark has secured exclusive marketing and distribution rights for the product, including an option to commercialize two additional Evestra vaginal ring products, for the US market.

A Timeline on NuvaRing Development and Commercialization

• NuvaRing was first approved in The Netherlands on February 14, 2001, then by all 14 other countries then in the European Union on June 12, 2001,
• NuvaRing approved in the United States by the U.S. Food and Drug Administration (FDA) on October 3, 2001.
• NuvaRing was first marketed in the United States in July 2002, followed by a number European countries since then.
• In March 2007, Organon announced the market launch of NuvaRing in Australia, bringing the total number of countries where NuvaRing is available to 32.
• Merck’s IMS Health NuvaRing registered sales of $768 million in 2016 in the US Market. NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is an estrogen/progestin combination hormonal contraceptive (CHC) indicated for use by women to prevent pregnancy.