Mylan N.V. (Nasdaq: MYL) and Mylan Inc. today announced the U.S. launch of its Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr, adding to its existing offering of Fentanyl Transdermal System 12, 25, 50, 75 and 100 mcg/hr. Mylan currently is the only manufacturer that offers eight Fentanyl Transdermal System dosage strengths, including three new strengths – the first and only available "intermediate" dosages.
Mylan CEO Heather Bresch commented: "Mylan's launch of Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr, is an example of our commitment to innovate to satisfy unmet needs. Mylan's Fentanyl Transdermal System is the number one dispensed fentanyl transdermal system in the U.S., and now, for the first time, patients have access to additional dosing options through Mylan's launch of three new strengths."
Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Supplemental Abbreviated New Drug Application (ANDA) for its Fentanyl Transdermal System 37.5, 62.5 and 87.5 mcg/hr.
Fentanyl Transdermal System's existing strengths, including the 12, 25, 50, 75 and 100 mcg/hr presentations, had U.S. sales of approximately $767 million for the 12 months ending September 30, 2014, according to IMS Health.
Currently, Mylan has 282 ANDAs pending FDA approval representing $104.6 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $27.2 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.