OxyContin and drug abuse go hand in hand in the public imagination these days. It's not a flattering combination for drugmaker Purdue Pharma. But drug abuse could end up helping the company prolong its monopoly.
As The Wall Street Journal reports, Purdue is aiming to extend its lock on OxyContin sales after the drug's patent expires next year. After all, the company spent $100 million to develop an "abuse-resistant" version launched in 2010. Because that version makes OxyContin harder to abuse, generics makers should be barred from copying the original version, Purdue maintains in a variety of lawsuits against those companies.
"We believe that no generics to OxyContin should be approved that are not formulated to be abuse-deterrent," a spokesman told the WSJ.
Generics companies say they can make their own formulations that deter abuse. Teva ($TEVA), for instance, tells the Journal that it has the capability to turn out a version equivalent to Purdue's new formulation. And FDA may well require generics makers to do so. The agency is considering requirements for OxyContin copycats, including reformulations designed to make abuse more difficult, the WSJ says.
The problem? Not much research has been done to show that Purdue's new formulation--which makes the pills more difficult to crush or to heat for injection--actually does deter abuse. The company says its own data shows the number of addiction-treatment admissions and the number of poison-control center interventions dropped after the reformulated version appeared. The generics makers say independent evidence is needed. We'll see what the FDA decides; the agency says it will give word by year's end.
- read the WSJ analysis