Mayne Pharma Group Limited (ASX: MYX) announced its Abbreviated New Drug Application (ANDA) for generic NuvaRing® has been accepted for filing by the US Food and Drug Administration (FDA).
NuvaRing is an intra vaginal hormonal contraceptive delivery device combining etonogestrel and ethinyl estradiol over a 3-week period. Merck’s NuvaRing had total US sales of approximately US$830 million for the 12 months ending 31 January 2018, according to IQVIA.
Mayne Pharma’s CEO Scott Richards said, “We are very pleased to have received filing acceptance for our generic NuvaRing, which is an important regulatory milestone. Generic NuvaRing is a complex and difficult-to-develop and manufacture product and complements our existing women’s health franchise of 21 marketed products. Following the Teva portfolio acquisition, Mayne Pharma became the second largest supplier of oral contraceptives in the US. NuvaRing is the largest contraceptive sold in the US$5.6 billion US contraceptive market with no generic equivalents today. We currently expect to commercialise our generic NuvaRing in FY19.”
In February 2017, the Company entered into a long-term exclusive license and supply agreement with Mithra Pharmaceuticals, SA (Mithra), a leading women’s health drug delivery company. Under the terms of the agreement, Mayne Pharma will have responsibility to market, sell and distribute the product following FDA approval and Mithra will be responsible for supply.
Mayne Pharma directly markets more than 55 products and has a growing pipeline of approximately 30 products targeting US markets with IQVIA sales greater than US$5 billion.
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