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news.Endo Pharmaceuticals has received a welcome decision from a US appeals court, which upheld the verdict of a lower court, dismissing claims that Endo's oxycodone extended-release tablets infringed upon a patent belonging to Purdue Frederick.
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Endo’s drug, a bioequivalent version of Purdue’s OxyContin, does not infringe patent protection according to the court ruling. This affirmation allows Endo to launch the tablets in four strengths; 10mg, 20mg, 40mg, and 80mg.
OxyContin is indicated for pain management when a continuous, around-the-clock analgesic is needed for an extended period of time. It is most commonly used among cancer patients and other patients with severe pain.
Purdue has said it will appeal the decision to a higher court.
The FDA has confirmed that Endo has 180 days of marketing exclusivity with respect to the 10mg, 20mg and 40mg strengths of the product because the company was the first applicant to file for these oxycodone extended-release strengths. This marketing exclusivity began to run upon the appellate court decision affirming the district court’s decision.
Following the court’s decision, shares in Endo have risen by nearly 23%.
Caroline Manogue, Endo’s executive vice president and chief legal officer said: “The affirmance of the patent fraud finding by the Federal Circuit now provides a legal basis to preclude Purdue or any other company from unfairly marketing the current NDA-based OxyContin product as a low price, so-called ‘authorized generic’ during Endo’s 180-day ANDA exclusivity period. Endo will immediately pursue all legal remedies against Purdue to preserve Endo’s rightful marketing exclusivity for its dosages.”