Mylan N.V. announced the U.S. launch of Armodafinil Tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon's Nuvigil®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) and was awarded 180 days of marketing exclusivity for these strengths.
Armodafinil Tablets are used to improve wakefulness in adults with excessive sleepiness associated with obstructive sleep apnea, narcolepsy or shift-work disorder.Mylan CEO Heather Bresch commented, "Mylan's launch of the first generic version of Nuvigil Tablets, 50 mg, 150 mg, 250 mg, reinforces our continued commitment to expanding access to high-quality, affordable medicine. This product adds to our growing portfolio of more than 600 products inNorth America across a vast range of therapeutic categories and demonstrates our continued leadership in bringing new generic medications to the market."
Armodafinil Tablets, 50 mg, 150 mg, 250 mg, had U.S. sales of approximately $489.7 million for the 12 months ending March 31, 2016, according to IMS Health.
Currently, Mylan has 254 ANDAs pending FDA approval representing $108.3 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $37.2 billion in annual brand sales, for the 12 months ending December 31, 2015, according to IMS Health.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,400 generic and branded pharmaceuticals, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in approximately 165 countries and territories. Our global R&D and manufacturing platform includes more than 50 facilities, and we are one of the world's largest producers of active pharmaceutical ingredients. Every member of our nearly 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at www.mylan.com.
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