OxyContin patent expires Tuesday but FDA under pressure to stall generics

Purdue's original patent on the superpotent and often abused painkiller OyxContin expires tomorrow, and drugmakers like Teva Pharmaceutical Industries ($TEVA) are jockeying for position to get a piece of its $2.8 billion market share. But just how quickly that might happen is anybody's guess. That's because the FDA is under increasing pressure to require generic drugmakers to incorporate some kind of tamper resistance into their formulations. 

"If the FDA doesn't act this time, there will be consequences," Rep. Hal Rogers (R-KY), co-chairman of the Congressional Prescription Drug Abuse Caucus, told The Wall Street Journal. Rogers and colleagues from both political parties have asked the FDA to require protections. They cite the drug's dangers, like Centers for Disease Control and Prevention statistics showing that overdoses of painkillers caused more deaths in 2010 than heroin and cocaine combined.  

Impax Laboratories ($IPXL) and Mallinckrodt, the generic division of Covidien ($COV), along with Teva, have asked the FDA for approval to make their own versions of the original OxyContin. In 2010, Purdue brought out a version, which it spent about $100 million developing, that is harder to crush and so harder to abuse. It has patent protection on that version until 2025, but doctors may not prescribe that over much cheaper generics if the FDA allows those onto the market. Some doctors who treat patients for chronic pain are of the opinion that restricting generic painkillers is not the answer to the addiction issue. They have added their voices to the debate as well.

Still, there is evidence that tamper-resistant versions can keep some addicts from using them. Citing IMS Health stats, WSJ said that when OxyContin was reformulated, its sales dropped 7% in the first year while sales of an unreformulated painkiller from Endo Pharmaceuticals ($ENDP) rose 72%. Then when Endo remade its Opana, the new drug's sales dropped 25%. The patent on Opana ER expired recently. 

Both Purdue and Endo have suggested that the FDA require the same kinds of protections their new drugs now contain, and even the White House has waded into the issue. Last month the National Association of Attorneys General asked the FDA to require the new technology. Drug abuse is often tied to many other crimes, like theft. 

But despite gathering lots of input, the FDA has yet to rule. According to the WSJ, the stalling has led generic drugmakers to consider whether to just go ahead and buy or develop and incorporate the technology in their own versions to get onto the market, which would solve the FDA's dilemma. 

- read the Wall Street Journal story (sub. req.)

 

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