Wall Street Journal (06/27/12) Martin, Timothy W.
OxyContin manufacturer Purdue Pharma is trying to extend the patent protection for the drug beyond 2013 by arguing that the new formulation which it spent $100 million to develop might substantially reduce abuse. Purdue says that the version of OxyContin introduced in 2010, which has patent protection until 2025, is more difficult to abuse than the original formulation. The company contends that generic-drug makers should be prevented from producing the original version of OxyContin, but the decision on whether the reformulation will be protected lies with the courts which are handling the 16 patent-infringement lawsuits against 10 generic-drug manufacturers. If Purdue Pharma loses its legal battles, the FDA might decide to hold off on giving the okay to generic versions of the drug, as it is currently reviewing what reformulations or safeguards it should require a generic OxyContin to contain, with a ruling expected by the end of the year. The effort is made more difficult by the fact that little research has been on whether such safeguards are effective in thwarting abuse. One of the safeguards is the infusion of polyethylene oxide, a polymer that makes the pill difficult to crush, and the other is an alteration of the formula which causes the pill's powdery contents to turn into a jellylike substance if water is added. A report required by the FDA was cited by Purdue Pharma as evidence that the new formulation is cutting down on abuse. The report shows that law-enforcement officials have found that the street price of OxyContin, which is indicative of demand, fell during the second quarter of 2011. The report also shows that number of visits to poison-control centers and admissions to addiction-treatment programs attributed to OxyContin declined after the reformulation.