This year, the FDA has approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence. Mylan Technologies Inc. and Dr. Reddy’s Laboratories SA received approval to market buprenorphine and naloxone sublingual film in multiple strengths. The approval comes with potential to increase access to these treatments for those with opioid use disorder.
“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are available to the patients who need them,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “That includes promoting the development of better drugs, and also facilitating the market for entry of generic versions of approved drugs to help ensure broader access.”
The film is applied under the tongue and serves as a medication-assisted treatment (MAT) – a comprehensive approach combining FDA-approved medications (methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder.
Regular adherence to MAT with buprenorphine has been shown to reduce opioid withdrawal symptoms, as well as the desire to use opioids. According to the Substance Abuse and Mental Health Services Administration, those receiving MAT treatment for opioid use disorder cut their risk of mortality from all causes in half.
In response to the generic challenge, Indivior Plc said it will launch a cheaper version of its blockbuster opioid addiction treatment, Suboxone, as it seeks to claw back market share lost to copycat versions of the drug.
The British drugmaker is also looking to reduce its dependence on Suboxone, which accounts for about 80 percent of its revenue, by focusing on another opioid addiction drug Sublocade and schizophrenia treatment Perseris.
It expects four generic versions of Suboxone in the market, including its own, Chief Executive Shaun Thaxter said in a call with analysts.
Last week Indivior won a fresh hold against a knock-off version from Dr. Reddy’s Laboratories, while Teva Pharmaceuticals said in September it would hold off launching its version until Indivior’s other cases were resolved.
Indivior said it expects its cheaper Suboxone copy to generate revenue in the range of tens of millions of dollars, but did not specify when it would be launched.
The company said it was confident of the drug generating peak net revenue of more than $1 billion.