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A generic manufacturer is fighting a restraining order against its sale of one of the first generic versions of buprenorphine and naloxone (Suboxone) sublingual film to treat opioid dependence, after FDA approved them late last week.
Mylan and Dr. Reddy’s Laboratories snagged approval for the generic sublingual versions fo Suboxone, part of medication-assisted treatment (MAT).
However, Indivior obtained a temporary restraining order from the U.S. District Court in New Jersey, blocking Dr. Reddy’s Laboratories from launching a generic version of Indivior’s Suboxone. “This order will stop Dr. Reddy’s launch activities before the court has had a chance to rule on the preliminary injunction motion. We will continue to pursue all legal avenues against Dr. Reddy’s to protect our Suboxone film patent estate,” said Shaun Thaxter, CEO of Indivior, in a statement from the company.
Dr. Reddy’s said in a statement that Indivior “will be required to post a bond or other security totaling $18 million to satisfy any losses or damages incurred by Dr. Reddy’s during the period of the temporary restraining order.” Dr. Reddy’s also noted that the temporary restraining order does not prohibit it from manufacturing the generic version.
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The Court has scheduled an expedited hearing of the preliminary injunction for June 28, and a ruling is expected soon thereafter.
FDA okayed the launch of the new generics to provide more access to medication-assisted treatment (MAT) therapies.
“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” said FDA Commissioner Scott Gottlieb, MD, in a FDA statement.
Buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support, FDA added.
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