Mylan Pharmaceutical's ($MYL) Xulane is the first generic contraceptive transdermal patch to hit the market, marking another milestone for the delivery technology.
Xulane is a generic version of Johnson & Johnson ($JNJ) and Janssen Pharmaceuticals' Ortho Evra (norelgestromin/ethinyl estradiol transdermal system). The FDA approved the product's Abbreviated New Drug Application (ANDA) on April 16, and the company announced the launch subsequently.
"Mylan is proud to continue expanding its portfolio of transdermal products through the launch of the first generic Ortho Evra Patch. Mylan's Xulane, 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," Mylan CEO Heather Bresch said in a statement.
According to Mylan's website, its patch consists of three layers: a protective backing, a middle layer containing an adhesive and the active ingredients, and a protective release liner that is removed immediately prior to application.
Xulane's active ingredients are the hormones norelgestromin and ethinyl estradiol. The FDA's website indicates that the generic's dosing and strength will be the same as those of its branded counterpart as well.
The market for contraceptive patches has proven to be a tough nut to crack. The FDA rejected Actavis' ($ACT) application for a progestin-only contraceptive patch, citing a lack of data among other concerns in December 2013.
Mylan's website says it was the first to receive approval for three other transdermal systems for the treatment of angina pectoris, symptoms associated with menopause and chronic pain.
According to Mylan's release, the company has 300 ANDAs pending FDA approval that represent $104.5 billion in annual brand sales. Forty-two of the ANDAs are potential first-to-file opportunities.
- read the release
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