Amneal Pharmaceuticals has launched EluRyng, a generic version of Merck’s birth control medication NuvaRing, following the US Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA).
EluRyng is a hormonal contraceptive that comprises a combination of etonogestrel and ethinyl estradiol. The company said that commercialisation activities for the in-house produced generic have commenced.
The medication, which expands Amneal’s portfolio of more than 300 generic drugs, is one of 15 new products that the company plans to launch over the coming 18 to 24 months.
Amneal Pharmaceuticals co-CEOs Chirag Patel and Chintu Patel said: “In addition, 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.”
Indicated to prevent pregnancy, NuvaRing is a small vaginal ring made of 11.7mg etonogestrel and 2.7mg ethinyl estradiol. On average, the ring releases 0.12mg etonogestrel and 0.015mg ethinyl estradiol per day.
In the third quarter of the year, the medication fetched $241m in sales for Merck, an increase from $234m in the corresponding quarter last year.
Amneal is the first company to secure the US regulatory approval for a generic version of NuvaRing, which has a market size of $800m, reported Livemint.
India-based Dr Reddy’s Laboratories and Israeli company Teva are also developing a generic for the birth control ring.
In August, Dr Reddy’s received a complete response letter from the FDA requesting additional data on the drug, delaying the planned launch of its generic this year, noted BloombergQuint.
The approval of Amneal’s medication led to a drop in Dr Reddy’s shares.