It's bad news for Purdue Pharma but good news for generics makers such as Teva Pharmaceutical Industries ($TEVA). A federal appeals court affirmed a lower court's decision to toss out some Purdue patents for its top-selling pain drug OxyContin, further opening the door to cheap knockoff versions of the blockbuster med.
The U.S. Court of Appeals for the Federal Circuit upheld earlier orders from a lower court judge that also favored generic drugmakers by invalidating four of Purdue's patents for OxyContin. Purdue is not taking the court's decision lying down, though, making it unclear when generics might make it to the market.
"We are reviewing the decision and considering our options concerning further appellate review," Purdue's General Counsel Philip Strassburger told FiercePharma in an email. Plus, the company "has several other patents protecting OxyContin" so Purdue "does not anticipate generic manufacturers selling generic versions of their products in the near future," Strassburger said.
As it stands, the only generic versions of OxyContin are "authorized generics," or exact copies of the brand-name version authorized by Purdue, Reuters points out.
In 2014, U.S. District Judge Sidney Stein in Manhattan said that some of Purdue's patents for OxyContin were invalid because they did not add significant changes to the drug. Three of Purdue's patents cover an improved formula for oxycodone, OxyContin's active ingredient, and another describes abuse-deterrent technology for the drug licensed from German phama Grunenthal GmbH, which is also named as a plaintiff in the suit, Reuters reports.
Purdue appealed, but the appeals court decision deals some cards in favor of generic makers such as Teva, Amneal Pharmaceuticals, Epic Pharma and a U.S. arm of Mylan ($MYL), who want to bring their cheap versions of the drug to market.
Meanwhile, Purdue is doing everything that it can to extend OxyContin's long and controversial go. In August, the company won FDA approval for its painkiller for children ages 11 to 16, sparking immediate public backlash.
Critics said that the agency's green light for OxyContin in kids would feed into the opioid overuse epidemic, an issue that Purdue has come under fire for in the past. The company last year said that it would not promote new pediatric safety and dosing information to doctors to reduce OxyContin's abuse potential and address concerns over the med.
- read the Reuters story
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