Sandoz will be marketing and distributing the authorized generic to Indivior’s brand product; authorized generics are made under a brand’s existing New Drug Application. Alvogen will be launching its generic equivalent of the product.
Buprenorphine and Naloxone Sublingual Film is indicated for the treatment of opioid dependence, as part of a complete treatment plan that includes counseling and support. The CIII scheduled drug combines buprenorphine, a partial-opioid agonist, and naloxone, an opioid antagonist. Under the Drug Addiction Treatment Act (DATA), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.
Both Companies plan to make the following strengths of Buprenorphine and Naloxone Sublingual Film available: 2mg/0.5mg, 4mg/1mg, 8mg/2mg, and 12mg/3mg.