The Food and Drug Administration has informed a British pharmaceutical company that it will not stop other drug makers from producing generic versions of Suboxone tablets, one of its top selling products. The move is a serious blow to Reckitt Benckiser’s efforts to maintain its monopoly of Suboxone, which generates sales of about $1.5 billion annually.
Two New Jersey based generic drug makers said they had obtained FDA approval and would immediately begin selling generic versions of buprenorphine, which is more widely known as Suboxone. The drug is increasingly being used to treat addiction to heroin and opioid painkillers such as Vicodin and OxyContin.
“The FDA’s decision to approve the first generic equivalents to Suboxone sublingual tablets will ensure that millions of patients in the U.S. who need this product now have access to a high quality, low cost generic version,” said Chirag Patel, President and Co-Chairman of Amneal, the largest generic drug maker in the U.S.
Actavis Inc. (NYSE: ACT) also said it had received FDA approval to make generic Suboxone and said it “intends to begin shipping the product immediately.”
Reckitt had filed a petition with the FDA last year to block generic tablets from coming on the market – claiming they were a safety risk to children. Reckitt also said it would stop selling the tablets in the United States, replacing them with a film version of Soboxone. Reckitt’s patent on Suboxone tablets expired three years ago, while its patent on Suboxone film doesn’t expire until 2022.
Generic drug makers complained to the agency that Reckitt was only trying to keep cheaper, generic versions of Suboxone from coming on the market – a complaint that apparently resonated with the FDA.
“The timing of Reckitt’s September 2012 announcement that it would discontinue marketing of the tablet product because of pediatric exposure issues, given its close alignment with the period in which generic competition for the product was expected to begin, cannot be ignored,” wrote Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a letter to Reckitt.
“Reckitt’s own actions undermine, to some extent, its claims with respect to the severity of the safety issue,” Woodcock wrote, adding that Reckitt failed to prove that film Suboxone was any safer than the tablets.
“RBP (Reckittt Benckiser Pharmaceuticals) is disappointed with the decision but will continue to work with the FDA on safety enhancements,” the company said in a statement.
In her letter, Woodcock also informed Reckitt that the matter was being referred to the U.S. Federal Trade Commission in response to complaints that Reckitt engaged in anti-competitive business practices.
Buprenophine (Suboxone) is an opioid that was first approved as a treatment for opioid addiction in the U.S. in 2002. Over three million Americans with opioid dependence have been treated with Suboxone. Although praised by addiction experts as a tool to wean addicts off opioids, some are fearful the drug is being overprescribed and misused.
A recent report by the Substance Abuse and Mental Health Services Administration (SAMHSA) found a ten-fold increase in the number of emergency room visits involving buprenorphine. Over half of the hospitalizations were for non-medical use of buprenorphine – with some users taking the drug to get high.
In a report published in the Journal of Addictive Diseases, the Center for Substance Abuse Research (CESAR) at the University of Maryland warned “there may be an epidemic of buprenorphine misuse emerging across the U.S.” Researchers said addicts were smuggling buprenorphine into jails and the drug’s street value was growing because it doesn’t show up in drug tests.
“The true magnitude and scope of buprenorphine diversion, misuse, and adverse consequences is unknown because current epidemiologic measures do not systematically monitor buprenorphine,” CESAR warned in a December, 2012 newsletter. “Similarly, buprenorphine-related deaths are not accurately tracked because medical examiners and coroners do not routinely test for the drug.”