Mylan, Inc,has announced the launch of its Nevirapine Extended-release tablets, 400 mg, which is the generic version of Boehringer Ingelheim's Viramune XR. Mylan received final approval from the US Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for combination antiretroviral (ARV) treatment of HIV-1 infection in adults and in children six to less than 18 years of age(1). The launch of this product continues to strengthen Mylan's growing ARV portfolio in the US Mylan has begun shipping product.
Nevirapine Extended-release tablets, 400 mg had US sales of approximately $61.9 million for the 12 months ending September 30, 2014, according to IMS Health.
Currently, Mylan has 287 ANDAs pending FDA approval representing $112.2 billion in annual brand sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $29.3 billion in annual brand sales, for the 12 months ending June 30, 2014, according to IMS Health.