A federal judge ruled that Purdue Pharma LP patents
protecting its painkiller OxyContin are invalid, clearing the way for drug maker Endo Pharmaceuticals Holdings Inc. to sell a generic version of the drug.
Purdue, based in Stamford, Conn., sued Endo for patent infringement in 2000 after Endo filed an abbreviated new drug application with the Food and Drug Administration to sell generic OxyContin, which is designed to treat moderate to severe pain.
In a 50-page opinion, U.S. District Judge Sidney H. Stein in Manhattan found that while Endo violated three of closely held Purdue’s patents on the drug, Endo “has proven by clear and convincing evidence that the patents are invalid due to Purdue’s inequitable conduct before the Patent and Trademark Office during the prosecution of the patents in suit.
http://phx.corporate-ir.net/phoenix…
Endo also has a Generic for Duragesic ready to launch, a new Sufentanyl patch in Clinical trials and OxyMorph SR in clinical trials.
here is something related
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By HARRY YANOSHAK
Bucks County Courier Times
Hospitals can expect more overdose deaths as cheaper, generic forms of
OxyContin and a more potent prescription painkiller enter the market, state Attorney General Jerry Pappert said yesterday.
At a news conference in Philadelphia, Pappert predicted there could be a surge in prescription drug abuse because the U.S. Food and Drug
Administration has approved two generic versions of OxyContin, a drug that has contributed to numerous overdose deaths across the state.
Additionally, the attorney general said he’s concerned about the potential introduction of a synthetic form of morphine called Palladone, which is made by the same manufacturer as OxyContin, Purdue Pharma of Stamford, Conn. The drug, which is four times as potent as OxyContin and just as addictive, is under review by the FDA.
“While the development of pain relievers is getting better, the potential for abuse is getting higher,” he said.
One generic form of OxyContin has entered the market. Drugmaker Teva
Pharmaceuticals of North Wales, Montgomery County, last month introduced a time-released version of oxycodone hydrochloride, the active ingredient in the brand-named drug. A second drug maker, Endo Pharmaceuticals, also has received FDA approval for its generic form, which hasn’t yet hit the shelves.
Pappert announced the hiring of additional investigators to tackle
prescription fraud and advocated a proposed bill in the state House
toughening penalties for illegally obtaining prescription drugs.
OxyContin is a time-released drug that has benefited millions with severe pain, but it’s also an abused drug. Abusers crush the tablet to receive a full 12-hour dose in one quick hit, achieving a heroin-like high.
Joining Pappert were two state representatives whose Philadelphia districts have lost many young lives to prescription drug abuse. John Taylor, R-Philadelphia, and Marie Lederer, D-Philadelphia, spoke in support of Taylor’s measure, House Bill 2019, which would tackle prescription fraud and related crimes.
“One problem we face is that prescription drug abuse doesn’t have the same social stigma attached to it as heroin or cocaine. This is a closet addiction,” Pappert said.
“What’s alarming about the attitude of prescription drug abusers is that many are young children,” Taylor said. “They don’t feel like they are druggies or addicts. They don’t have to go on a dark street corner to buy drugs. To them, this is an almost antiseptic way to abuse drugs.”
Legislators are concerned that Palladone can be crushed like OxyContin, and that the manufacturer hasn’t reformulated either drug to make it tamper resistant.
James Heins, a spokesman for Purdue Pharma, said the science to develop such tamper-resistant drugs isn’t available, but the company is working on it.
“It’s very complicated science, very difficult, to make one drug that would work one way in one population and work one way in another. We’re talking about humans here,” Heins said.
OxyContin made headlines locally with the arrest of Dr. Richard Paolino, a Bensalem physician whose office issued numerous illegal prescriptions for the painkiller.
Before he was arrested, Paolino was the primary source of OxyContin in the region, Pappert said. The drugs he prescribed contributed to dozens of overdose deaths in Philadelphia, he said.
The FDA approvals for the generic forms of OxyContin come with the condition that the drug makers include abuse warnings and operate a risk-management program designed to limit the possibility of illicit use.
The Associated Press contributed to this story. Harry Yanoshak can be
reached at 215-949-4203 or hyanoshak@phillyBurbs.com.