UPDATE: FDA approves first generic version of Suboxone sublingual film

15 June 2018

Shares of London-listed Indivior (LSE: INDV) plunged 24.21% to 375.80 pence today, after it was revealed that the US Food and Drug Administration on Thursday approved the first generic versions of Indivior’s top-selling opioid addiction treatment Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence.

Netherlands-incorporated Mylan (Nasdaq: MYL) and India’s Dr Reddy's Laboratories (BSE: 500124) received approval to market buprenorphine and naloxone sublingual film in multiple strengths, and the latter has said it will be launching the drug, which will be on an ‘at risk’ basis due to ongoing litigation. Indivior had previously settled with Mylan until 2023; hence if Mylan also decides to launch behind Dr Reddy’s then it would also be at-risk.

Indivior will ‘pursue all legal remedies’

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