Iroko Pharmaceuticals announces key patent grant for Zorvolex

Zorvolex was approved in October 2013 by the US Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults.

Iroko president and CEO John Vavricka noted this first ZORVOLEX patent is significant as it provides additional exclusivity protection to the commercial prospects of the company’s first FDA-approved product, which represents a new approach to pain management.

"Specifically, this patent covers our ZORVOLEX product made using the SoluMatrix Fine Particle Technology™ licensed to Iroko by iCeutica Inc. for exclusive use in nonsteroidal anti-inflammatory drugs (NSAIDs), the same technology that forms the foundation of our deep NSAID pipeline," Vavricka added.

The term of the issued patent expires no earlier than 2030. In addition, ZORVOLEX has three years of regulatory exclusivity through FDA’s regulatory pathway.

The patent will be listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book, which includes all FDA-approved drugs, as well as patents and exclusivity information associated with those drugs.

ZORVOLEX does not have any therapeutic equivalents and thus is not interchangeable with other formulations of oral diclofenac, even if the milligram strength is the same.