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news.Collegium Pharmaceutical, a specialty pharmaceutical company, has announced that U.S. Patent No. 8,758,813 has been issued by the U.S. Patent and Trademark Office (USPTO).
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The patent relates to Collegium’s Oxycodone DETERx formulation and contains claims that cover the Company’s lead product, an abuse-deterrent, extended-release oxycodone product utilizing its proprietary DETERx technology.
Collegium currently has six U.S. patents that are Orange Book listable. All issued patents provide protection until 2025. Outside of the U.S., Collegium has three patents in Japan, Australia and Canada.
Oxycodone DETERx is currently in Phase 3 clinical development and topline data is anticipated in Q3 2014. The product has been designated Fast Track Status by the FDA.
In addition to the Phase 3 study to establish the safety and efficacy of the product, Collegium has executed a comprehensive development program for evaluation of the product’s abuse-deterrent properties consistent with FDA’s 2013 Draft Guidance, "Abuse-Deterrent Opioids – Evaluation and Labeling."
"The newly issued patent strengthens and expands our patent coverage for Oxycodone DETERx, our lead development product. We are continuing to focus on the prosecution of additional patents that support our lead product and the DETERx technology in both the U.S. and internationally," states Michael Heffernan, CEO of Collegium.