Purdue fights to extend OxyContin monopoly

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OxyContin is set to go off patent next year, but the maker of the powerful and heavily abused prescription painkiller is trying to extend its exclusive rights to the drug, arguing that a new version it spent $100 million to develop might substantially curtail abuse.

Whether Purdue Pharma LP will be able to protect its reformulated OxyContin will be decided by the courts. The company has 16 patent-infringement lawsuits pending against 10 generic-drug manufacturers, including Watson Pharmaceuticals Inc. and Teva Pharmaceutical Industries Ltd.

The Stamford, Conn.-based company says the new version of OxyContin it introduced in 2010, and which has patent protection until 2025, makes it tougher to abuse than the original formulation, whose patent expires next year. Generic-drug makers should be prevented from producing the original version of OxyContin, it says.

"We believe that no generics to OxyContin should be approved that are not formulated to be abuse-deterrent," says a spokesman for the company, whose OxyContin sales reached more than $2.8 billion last year.

Manufacturers of generic drugs say Purdue Pharma is just trying to protect a lucrative market for itself, and that they can make their own abuse-deterrent formulations of the drug.

Even if the company loses its legal battles, the Food and Drug Administration may still stave off generic versions of the drug. The FDA is reviewing what reformulations or safeguards it should require generic OxyContin to contain, and is expected to rule by the end of this year.

"We need to make it possible to make these abuse-deterrent formulations," Douglas D. Throckmorton, a deputy director in the FDA's Center for Drug Evaluation and Research, said in an interview.

The agency's decision could have wide-ranging implications for the nation's war on drugs. Painkillers caused more deaths in the U.S. in 2011 than heroin and cocaine combined, and drug and law-enforcement officials are struggling to figure out how to contain illegal trafficking in the legal medications.

Complicating the matter for the FDA, however, is the fact that little research has been done to show whether the safeguards like those Purdue Pharma has patented are effective in thwarting abuse.

OxyContin abusers typically heated or crushed the original pills, then injected, snorted or smoked their contents, for a heroinlike high. The semisynthetic opiate stimulates nerve receptors to block pain and produces a feeling of euphoria.

The new version of the pill is infused with polyethylene oxide, a polymer that makes the pill tough to crush for snorting or to heat for intravenous injection. The company also altered the formula so that the pill's powdery contents turn into a jellylike substance if water is added to make a solution for an injection. Users can still get high from the pills if they are willing to swallow enough of them or engage in more elaborate processing.

In past years the company has faced lawsuits from federal and state officials alleging it deceptively marketed OxyContin as being less addictive and less prone to abuse than other painkillers, because of the drug's extended-release formula. The lawsuits alleged that this marketing made doctors more comfortable prescribing OxyContin and contributed to an upsurge in painkiller abuse in the past decade.

In 2007, Purdue Pharma pleaded guilty in federal court in Virginia to criminal charges of misbranding the drug with the intent to defraud and mislead the public about its addictive qualities. The company and three top executives paid a $634 million fine. The same year, Purdue agreed to a $20 million settlement of similar allegations with 27 state attorneys general.

In connection with the settlement with the Justice Department, Purdue acknowledged that some sales representatives and managers made misstatements in the promotion of OxyContin in violation of Purdue policies that overstated benefits and understated risks.

OxyContin was unlike nearly every other painkiller when it hit the market in 1995. Its extended-release mechanism meant patients in searing pain could take just one pill every 12 hours. Few other widely-prescribed oral painkillers approach the strength of OxyContin's 80-milligram tablet—more than double the dosage of most opioid painkillers.

As evidence the new formulation is cutting down on abuse, the company cited a report the FDA required it to compile and submit. The report, citing preliminary data, says that the street price of OxyContin—an indication of demand—fell to 65 cents per milligram in the second quarter of 2011, a 22% decline from its 81-cent price in the first quarter of 2010, based on a survey of 300 law-enforcement officials in all 50 states.

The number of visits to poison-control centers and admissions to addiction-treatment programs attributed to OxyContin also showed declines after the reformulation, according to the report, part of a number of continuing studies.

The Generic Pharmaceutical Association, a trade group for generic-drug makers, questions the effectiveness of Purdue's new formulation, pointing to the lack of independent evidence. Regulators and doctors should decide, it argues.
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full article @ http://online.wsj.com/article/SB10001424052702304458604577488720888157992.html
 
"smoked their contents" - no offense, but anyone who does this is wasting the majority of the drug
"The semisynthetic opiate..." - semisynthetic means opioid as there are only 2 true opiates: codeine and morphine...
Yes this is nit picky but I'm just in a very dickish mood today:p

Also, from my last stay in treatment, due to the new formulation of OC lots of people I know switched to opana or heroin. Go-go morphine (morphones included) type drugs!

P.S.- I think Purdue just wants more money and to corner the market as Shire did with Adderall for adult ADHD/ADD
 
Absolutely ridiculous, Purdue think they get to make their millions off the original formulation and now turn around saying that it is too dangerous for anyone else to sell, despite the fact they still sell the original formulation elsewhere in the world. What greedy fucking bastards, I really hope they don't get away with this crap.

+1 Crankinit, much as I think they are hypocrites to continue selling the original OxyContin here in Australia and say others should be unable to do so in the US I would be devastated to hear the OP's were coming to Australia.
 
Absolutely ridiculous, make a killing in sales on a product Purdue themselves admitted they broke the law by recommending 8 hour dosage intervals instead of 12 to maximize profits and now they don't think anyone else should be manufacturing/selling it because it's dangerous! If the judge(s) don't see the obvious racket they're either part of it or there's something seriously wrong with the justice system when it comes to corporate crime. Sometimes I wish China would invade already. But then I remember that they shoot drug dealers and perhaps heavy users.
 
Serotonin101 said:
"smoked their contents" - no offense, but anyone who does this is wasting the majority of the drug
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Smoking the original OCs was actually quite effective. More intense than snorting, but only seemed to last an hour. I'd guess that 50% is absorbed.

Really the OGs were so abusable orally, snorted, smoked, and injected, with the way they marketed it, and as concentrated a source of oxycodone as it was, it makes me wonder if Purdue set out to make a major drug of abuse.They dealt drugs the smart way, through a corporation, with the support powerful people, and jumped through the regulatory hoops.
ro4eva said:
Absolutely ridiculous, make a killing in sales on a product Purdue themselves admitted they broke the law by recommending 8 hour dosage intervals instead of 12 to maximize profits and now they don't think anyone else should be manufacturing/selling it because it's dangerous!
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I swear they did that so some would get diverted to the black market. If anyone else sold drugs for the black market on they scale of Purdue they'd be eligible for the death penalty under the Kingpin act. But since they're a corporation they got a fine and probation. Can you piss test a corporation?

I think now that the patent is up for Oxycontin Purdue's arguing that the OPs are actually a new medication, not a reformulation of an old one, so they can still at least have a monopoly in ER oxycodone in the legit pain market. They're claiming that the original OC were a different drug pulled off the market due to safety reasons, which would block generics from being produced. I think the OPs were required in a settlement for illegally marketing Oxycontin. Talk about turning lemons into lemonade.

I see parallels to Quaalude, with the way it was marketed, supported and they even had "Stress Clinics" not unlike pain clinics. Still, OC80 will probably be as legendary as Rohr 714, a drug we'll say we had back in the day.
 
This is almost like a street dealer going to court and trying to say they have the best gear and only they should be able to sell their drugs on the streets.
A bit simplified I know but that's what it makes me think of.
 
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