FDA approves first generic Suboxone

Jun 18, 2018

Mylan and Dr. Reddy's Laboratories have both received FDA approval to make the first generic versions of a Suboxone under-the-tongue film for the treatment of opioid addiction.

However, approval does not mean the generic product — a film strip that combines buprenorphine and naloxone — will quickly enter the market. Indivior, the patent-holder, announced that U.S. district court of New Jersey had granted it a restraining order compelling rival drugmaker Dr. Reddy's to temporarily cease activities related to the development and marketing of the drug. Mylan had previously reached a settlement with Indivior, agreeing to delay launching its generic until 2023.

The Suboxone brand brought in as much as $2 billion in sales a year for U.K.-based Indivior.

Read the FDA announcement