Generic Suboxone Strips Get The Green Light

By Keri Blakinger 06/18/18

The FDA's move could mean wider availability and more competitive pricing for the popular addiction-fighting drug. 

pharmacist and customer talking at pharmacy counter

The FDA last week sparked a flurry of legal wrangling when it gave the go-ahead for two drugmakers to sell generic versions of Suboxone strips.

Part of an agency push to expand access to medication-assisted treatment, the move could open up the door to more competitive pricing for the popular addiction-fighting drug—but it also turns up the heat in an ongoing battle between drug companies intent on protecting profits. 

“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,” Commissioner Scott Gottlieb said in a statement. “That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”

Currently, the brand-name under-the-tongue strips are sold by Indivior and cost around $200 per month without insurance. The British company is already embroiled in litigation over claims that it strategically worked to block competition from generic Suboxone in order to maintain soaring profits. At one point, the drug brought in $2 billion in sales a year, according to FiercePharma.

But now, the Pennsylvania-based drug maker Mylan and the India-based company Dr. Reddy’s both have the green light to bring out generic versions of the drug. Mylan did not immediately comment on the approval or its plans moving ahead, but the Hyderabad competitor issued a statement Friday praising the move and detailing its 2 mg, 4 mg, 8 mg and 12 mg formulations.

“With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone could not have come at a more critical time to help patients,” said Dr. Reddy’s CEO Alok Sonig. 

But Indivior took the matter straight to the courthouse and on Friday—just a day after the FDA announcement—the company won a temporary restraining order blocking Dr. Reddy’s from moving forward with its product release in light of ongoing patent litigation. A judge will decide on the path ahead at a June 28 federal court hearing in New Jersey. 

Indivior CEO Shaun Thaxter put out a statement expressing surprise at his competitor’s decision to launch the generic drug—and promised to keep up the courtroom fight.

“We will continue to pursue all legal avenues, including an immediate injunction until the legal status of our intellectual property is confirmed by the courts,” he said.

And Mylan won’t necessarily have an easier time pushing out its generic formulation of the medication-assisted treatment, as the company had previously agreed to delay its generic launch until 2023.

Suboxone, which combines naloxone and buprenorphine to ease withdrawal and fight cravings, initially hit the U.S. market in 2002 as a pill. Five years later, Indivior announced plans to launch a sublingual film, a formulation that wouldn’t immediately have a generic alternative. 

But in 2016, 35 states joined together to sue the company for anticompetitive practices. The states claimed that Indivior raised unfounded safety concerns to delay the FDA’s approval of the generic Suboxone tablet. Then, the company allegedly used those concerns to push strips over pills, a move that the states alleged was intended to prevent patients from taking generic versions of the pill. 

The Federal Trade Commission (FTC) has since been investigating the company over antitrust claims, according to reports. 

Whatever the legal drama surrounding the drug approvals, the FDA framed its announcement as an important step toward increasing access to lifesaving treatments and reducing stigma around medication-assisted treatments.

“The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction,” Gottlieb said. “When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”

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Keri Blakinger is a former drug user and current reporter living in Texas. She covers breaking news for the Houston Chronicle and previously worked for the New York Daily News and the Ithaca Times. She has written about drugs and criminal justice for the Washington Post, Salon, Quartz and more. She loves dogs and is not impressed by rodeo food. Find Keri on LinkedIn and Twitter.