FDA Approves First Generic Version of NuvaRing

The FDA has given approval to an Abbreviated New Drug Application for the etonogestrel/ethinyl estradiol vaginal ring (EluRyng, Amneal Pharmaceuticals), the first generic version of NuvaRing. Amneal has initiated commercialization activities for the etonogestrel/ethinyl estradiol vaginal ring, which is being manufactured internally.

“We are pleased to announce FDA approval of EluRyng, one of 15 new, complex products we expect to launch over the next 18 to 24 months,” said Chirag and Chintu Patel, co-chief executive officers. “[…] EluRyng adds a differentiated, complex dosage form to our portfolio, and bringing this product to market reflects our commitment to improving affordable access to complex drug products. Looking ahead, we remain enthusiastic about the additional high-value opportunities in our pipeline that are designed to improve the lives of patients and drive meaningful growth and value-creation for our shareholders and other stakeholders in 2020 and beyond.”

The etonogestrel/ethinyl estradiol vaginal ring is a flexible birth control used to prevent pregnancy. In a given 4-week cycle, the etonogestrel/ethinyl estradiol vaginal ring must be inserted into the vagina to be removed after 3 weeks (21 days) and a new ring inserted 1 week (7 days) later.²

According to the company press release, US sales for the etonogestrel/ethinyl estradiol vaginal ring for the 12 months that ended October 31, 2019, were approximately $967 million.¹

Reference

1. Amneal Receives Abbreviated New Drug Application Approval for EluRyng, the First Generic NuvaRing [press release]. Business Wire website. Published December 12, 2019. https://www.businesswire.com/news/home/20191212005334/en/Amneal-Receives-Abbreviated-New-Drug-Application-Approval. Accessed December 13, 2019.

2. NuvaRing, Merck website. 2018. https://www.nuvaring.com/how-to-use-nuvaring/. Accessed December 13, 2019.