A generic drugmaker has accused a British pharmaceutical company of putting profits ahead of patients in its efforts to block cheaper generic versions of Suboxone from coming on the U.S. market. Suboxone is a drug used to treat opioid addiction.
In a letter to the Food and Drug Administration, Amneal Pharmaceuticals said Reckitt Benckiser was engaged in a “sophisticated, strategic campaign to preserve (its) multi-billion dollar Suboxone monopoly.”
Citing safety concerns, Reckitt announced in September that it would pull tablet versions of Suboxone off the U.S. market over the next six months. Reckittt said it made the decision after a study found that “accidental unsupervised pediatric exposure” to Suboxone pills was over eight times more likely than the film version of the drug. Suboxone film is designed to dissolve under the tongue and each dose is individually wrapped – which Reckitt says makes the film more child resistant. The film version contains the same active ingredients as the tablet.
Reckitt also filed a petition with the FDA asking the agency to deny approval for new versions of Suboxone unless it came in similar child resistant packaging. Amneal said the Reckitt (RBP) petition was “transparently disingenuous.”
“RBP’s petition raising purported safety issues with Suboxone Tablets, which RBP has sold without competition for 10 years, is… just the latest maneuver in its effort to protect its Suboxone monopoly,” Amneal said in its letter to the FDA.
“Reckitt’s petition does not present a valid scientific or regulatory issue. In this instance, it is clear that the presence of the generic products on the market will have no negative effect on the public health. Indeed, RBP continues to market Suboxone Tablets as it has done over the last 10 years, and the generic products will be as safe as RBP’s Suboxone Tablets.”
Amneal and other generic drug makers are anxious to enter the lucrative market for Suboxone. Sales of Suboxone tablets and film reached $1.3 billion in the U.S. in 2011 and are growing by about 10% annually.
Reckitt’s tablet formula for Suboxone went off patent in 2009 and the company faces increasing competition from competitors. The film version is still patent protected and accounts for a growing share of Suboxone sales. Reckitt warned shareholders in its annual report that “up to 80% of the revenue and profit from the suboxone tablet business in the U.S. might be lost” to generic competition.
Suboxone contains naloxone and the opioid buprenorphine. The two drugs are combined to help wean addicts off more powerful narcotics such as Vicodin, OxyContin, oxycodone, and hydrocodone. Naloxone is added to Suboxone to block opioid receptors in the brain and central nervous system.
Since Suboxone was introduced in the U.S. in 2003, it has been used to treat over three million Americans with opioid dependence.
“We at Reckitt Benckiser Pharmaceuticals continue to believe it is in the best interest of public health and safety for FDA to require all manufacturers of buprenorphine-containing products for the treatment of opioid dependence – not just manufacturers of generic tablets – to implement class-wide public health safeguards involving pediatric exposure educational campaigns and child resistant, unit-dosed packaging to reduce the risk of pediatric exposure,” said Tim Baxter, Global Media Director for Reckitt, in an emailed statement to National Pain Report.
In a recent report published in the Journal of Addictive Diseases, the Center for Substance Abuse Research at the University of Maryland warned “there may be an epidemic of buprenorphine misuse emerging across the U.S.” because Suboxone was being so widely prescribed to treat addicts. 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.