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Make Way for Generic Suboxone

Good news for opioid addicts: Reckitt-Benckiser has finally lost its lucrative monopoly on Suboxone.


640,000 suboxone patients may rest easy
after this new ruling. Photo via

By Tony O'Neill


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It seems generic Suboxone is finally on the way. Manufacturer Reckitt Benckiser has lost its bid to block rivals from producing a generic version of the pill, which has proved a lifesaving intervention for countless opioid addicts. Despite evidence that suboxone is more effective as a low-dose substitute than methadone, its high cost has meant that up until now many addicts simply couldn't afford it. The ball started rolling for generic Suboxone in 2009, when Reckitt’s exclusivity status expired. Since then, the British pharma company has been working to protect its profit margin: In 2012 it started hiking the prices of traditional Suboxone pills, in an effort to shepherd people toward the costlier sublingual-film version. (Reckitt’s patent on the film version will remain firmly in place until 2022.)

A little later in the year, the folks at Reckitt announced that they were pulling the pill version off the market altogether, citing data—specially commissioned by Reckitt—ostensibly in view of “consistently and significantly higher rates of accidental unsupervised pediatric exposure” for the pill form compared to the film. That same day they filed a Citizen’s Petition with the FDA, asking the agency not to approve any generic versions of Suboxone tablets unless the manufacturers implemented “national public health safeguards involving pediatric exposure educational campaigns and child-resistant, unit-dosed packaging to reduce the risk of pediatric exposure." In other words, Reckitt fought to keep its monopoly using that old argument: “Think of the children!” And many patients were still denied cheaper meds. The Fix has previously reported on the disparity in treatment quality for opioid addicts who can't afford Suboxone. While methadone has long been a genetic drug and therefore available on the cheap—or even for free—the cost of Suboxone treatment can hit $500 per month for the prescription alone.   

Today the company—better known for marketing cleaning products in the UK—received a one-two blow from the FDA with the news that two generic versions of Suboxone tablets have been approved for sale in the US. The regulator also said that it had received comments accusing Reckitt of “anti-competitive practice,” and called out the company for scaremongering about the increased risk of pediatric exposure to the pill form of the drug. "While FDA welcomes and encourages sponsors to utilize unit-dose packing for their oral buprenorphine products,” they conclude, “we do not believe the data at this time support refusing to approve applications that lack such packaging."

Few who have spent time at methadone clinics will be surprised to see drug manufacturers treating patients with such little regard. But it's still rare to get such a clear peek at the kind of chicanery that often goes on behind closed doors. Today’s ruling benefits an estimated 640,000 patients in the US who currently rely on Suboxone.

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