Mylan NV on June 1 announced the US launch of Armodafinil tablets, 50 mg, 150 mg, 250 mg, a generic version of Cephalon’s Nuvigil. Mylan received final approval from the 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 says in a release, “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 in North 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 US 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.