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news.Iroko Pharmaceuticals, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced the issuance of the first patent for the composition of matter and formulation of TIVORBEX (indomethacin) capsules by the US Patent and Trademark Office (USPTO).
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The company also received a second patent for ZORVOLEX (diclofenac) capsules covering its manufacturing method. ZORVOLEX and TIVORBEX were approved in October 2013 and February 2014, respectively, by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate acute pain in adults.
"The issuance of our first patent for TIVORBEX is significant as it marks the second received this year to cover our portfolio of low dose nonsteroidal anti-inflammatory drugs (NSAIDs) made using the SoluMatrix Fine Particle Technology licensed to Iroko by iCeutica Inc.," said John Vavricka, President and CEO of Iroko.
The term of the issued TIVORBEX patent expires no earlier than 2030. In addition, TIVORBEX 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.
In addition to the first patent for TIVORBEX, a "method of making" patent was also received for ZORVOLEX. ZORVOLEX received an Orange Book listed composition of matter and formulation patent in March of this year. This ZORVOLEX patent expires no earlier than 2030.
"These two new patents are evidence of the great strides we have made over the last year with our SoluMatrix NSAID franchise. In addition, it reflects our fruitful collaboration with our partner, iCeutica, and the high quality work of our combined team," said Osagie Imasogie, Executive Chairman of the Board, Iroko Pharmaceuticals.