Iroko Pharmaceuticals gets new patent for Zorvolex from USPTO

The patent was issued by the United States Patent and Trademark Office (USPTO) and will be listed in the US Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication, or Orange Book.

Zorvolex is approved by the U.S. Food and Drug Administration (FDA) for the management of mild to moderate acute pain and osteoarthritis pain, and is available at pharmacies across the United States.

"We are excited to receive yet another patent on our flagship product, Zorvolex, which is another testament to our ongoing, successful collaboration with iCeutica," said Osagie Imasogie, Executive Chairman of the Board and Chief Executive Officer of Iroko Pharmaceuticals.

The term of the issued patent expires no earlier than 2030. In addition, Zorvolex has three years of regulatory exclusivity from date of product approval through FDA’s regulatory pathway. Iroko and iCeutica continue to prosecute additional patent applications for these and other products in the Iroko portfolio.

Zorvolex was developed to align with recommendations from FDA and several professional medical organizations that NSAIDs be used at the lowest effective dose for the shortest possible duration consistent with individual patient treatment goals.

Zorvolex is the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology and is now available by prescription.

Zorvolex contains diclofenac as submicron particles that are approximately 10 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. In 2014, Zorvolex was shortlisted in the Best New Drug category for the 10th Annual SCRIP Awards, an award which recognizes excellence in pharmaceutical development.