Global pharmaceutical company Mylan N.V. announced the U.S. launch of Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg, a generic version of Indivior’s Suboxone® Sublingual Film. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for the treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support.
Prescription of this product is limited to healthcare providers who meet certain qualifying requirements including notification to Department of Health and Human services of their intent to prescribe this product.
U.S. sales for Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg, were approximately $1.87 billion for the 12 months ending December 31, 2018, according to IQVIA.
Currently, Mylan has 173 ANDAs pending FDA approval representing approximately $85.8 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $53.6 billion in annual brand sales, for the 12 months ending June 30, 2018, according to IQVIA.