Mylan Inc’s US based subsidiary Mylan Pharmaceuticals has launched Xulane (norelgestromin/ethinyl estradiol transdermal system 150/35 mcg per day), the generic version of Janssen Pharmaceuticals‘s Ortho Evra (norelgestromin/ethinyl estradiol transdermal system 150/35 mcg per day).
This product is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception. Mylan received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for this product.
Mylan chief executive officer, Heather Bresch commented: “Mylan is proud to continue expanding its portfolio of transdermal products through the launch of the first generic Ortho Evra Patch. Mylan’s Xulane (norelgestromin /ethinyl estradiol transdermal system 150/35 mcg per day), which provides women with a high quality, affordable treatment option, once again demonstrates Mylan’s commitment to bring to market difficult-to-develop and -manufacture medicines in support of our mission to expand access to high quality medicine.”
Ortho evra had US sales of approximately $152.9 million for the 12 months ending December. 30, 2013, according to IMS Health.
Currently, Mylan has 300 ANDAs pending FDA approval representing $104.5 billion in annual brand sales, according to IMS Health. Forty-two of these pending ANDAs are potential first-to-file opportunities, representing $25.4 billion in annual brand sales, for the 12 months ending December 31, 2013, according to IMS Health.