Mylan scores FDA approval of generic Suboxone for opioid addiction, but a strong launch is no sure bet

Mylan scores FDA

Just one day after the FDA warned Mylan it would issue a second thumbs-down on its generic asthma drug Advair—causing investors to push the stock down 5%—the agency granted the company a small but important win. Mylan scored one of two approvals of the first generic versions of sublingual Suboxone, which is widely used to treat opioid addiction.

But the launch of the product, a film strip that combines buprenorphine and naloxone, will present a host of challenges for Mylan. The FDA also approved a generic version of the product made by India’s Dr. Reddy’s, which promptly announced (PDF) plans to launch four doses of it in the U.S.

Suboxone once brought in $2 billion in sales a year for its patent holder, U.K.-based Indivior. Both generics makers would be entering the U.S. market “at risk,” because Indivior is wrapped up in patent litigation with them in an ongoing attempt to hold off generic competitors. Mylan had previously reached a settlement with Indivior, agreeing to hold off launching its generic until 2023.

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