Mylan strives to design, develop and manufacture high quality, innovative transdermal drug-delivery systems—adhesive patches that deliver medication through the skin. These medicines treat a variety of conditions across several therapeutic categories.
We were the first to receive approval for generic nitroglycerin, estradiol and fentanyl transdermal systems. We also produce transdermal clonidine and aided in the development of EMSAM® (selegiline transdermal system), which is manufactured by Mylan today.
In 2014 we launched XULANE® (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day). With this launch we become the first company to release a generic version of Janssen Pharmaceuticals Inc.'s ORTHO EVRA® (Norelgestromin / Ethinyl Estradiol Transdermal System 150/35 mcg per day).
Also in 2014 we launched Estradiol Transdermal System, USP, (twice-weekly) in 0.1 mg/day, 0.075 mg/day, 0.05 mg/day, 0.0375 mg/day, 0.025 mg/day strengths. This product is the first bioequvalent (AB-rated) alternative to Novartis Pharmaceutical's Vivelle-Dot® to be approved.
As we bring new transdermal products to market in these and other categories, our expertise continues to focus on coating, die cutting, packaging, material selection and formulation.
Matrix Transdermal Delivery Systems comprise a family of patch assemblies covered by U.S. and international patents. These products typically comprise three main components.
- Backing Film: Occlusive films of varied composition and/or thickness.
- Adhesive: An adhesive layer that incorporates the active ingredient; featuring silicone, acrylic and/or polyisobutylene adhesive formulations.
- Release Liner: Removable coated film or polymer based protective layer.