Mylan’s generic Buprenorphine and Naloxone Sublingual Film are indicated for the treatment of opioid dependence.
There are limited options for people seeking treatment of opioid dependency. One of those options is the branded product Suboxone® Sublingual Film (Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg) from Indivior. According to IQVIA, sales of Buprenorphine and Naloxone Sublingual Film (8 mg/2 mg and 12 mg/3 mg) in the United States in 2018 totaled approximately $1.87 billion.
Now there is a generic version of Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg on the market. Following the approval of its Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA), Mylan Pharmaceuticals announced that it has launched its generic product for the treatment of opioid dependence as part of a complete treatment plan that includes counseling and psychosocial support.
Only healthcare providers that meet specific requirements, including notification to Department of Health and Human Services of their intent to prescribe this product, are permitted to prescribe Buprenorphine and Naloxone Sublingual Film, 8 mg/2 mg and 12 mg/3 mg.
Following this latest ANDA approval, Mylan still has an additional 173 ANDAs waiting for FDA approval that represent approximately $85.8 billion in annual brand sales, according to IQVIA.