A lawsuit against IntelliPharmaCeutics International Inc. is alleging that the company's Rexista infringes on the plaintiff's patents. Rexista is IntelliPharmaCeutics' abuse-deterrent oxycodone hydrochloride tablets for pain relief and is pending U.S. FDA approval.
Plaintiffs Rhodes Technologies, Grünenthal GmbH, and Purdue Pharma LP and its affiliates Purdue Pharmaceuticals LP and The P.F. Laboratories Inc. are alleging that Rexista infringes on six of their 16 patents in the suit filed with the U.S District Court for the District of Delaware.
As a result of the legal action, the U.S. FDA is stayed for 30 months from granting final approval to the drug. The stay period commenced Feb. 24, when the plaintiffs were notified of Intellipharmaceutics' certification with the FDA that Rexista did not infringe on any of the plaintiff's 16 patents.
The stay will expire Aug. 24, 2019, unless terminated by the courts or the parties reach a settlement.