Egalet Corporation, a fully integrated specialty pharmaceutical company, announced the United States Patent and Trademark Office (USPTO) has issued patent number 9,498,446 covering Egalet's proprietary Guardian Technology abuse-deterrent products which contain a matrix and an exterior shell including phase 3 product candidate, Egalet-002. The patent offers protection through February 2030 for Egalet-002 and other products developed with a shell using Guardian Technology.

Egalet-002, an extended-release, oxycodone formulation designed to deter common routes of abuse and in late-stage development for the management of pain severe enough to require daily around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate, uses Egalet's proprietary Guardian Technology. The physical hardness of the tablet and the gelling effect of the matrix combine to give Egalet-002 its physical and chemical abuse-deterrent characteristics. Egalet-002 is currently in a Phase 3 clinical programme and human abuse potential studies.

"The newly issued patent strengthens our overall protection for Egalet-002 which was specifically designed to address common routes of abuse including nasal—the most common method of abuse for oxycodone," said Bob Radie, president and chief executive officer of Egalet. "The Orange Book listable patent further strengthens the position of future products developed using the Guardian Technology matrix plus a shell design providing opportunities beyond Egalet-002."

Egalet currently has been granted 17 US patents and 83 patents outside of the United States that cover Guardian Technology and its product candidates.

Egalet's Guardian Technology has many applications and has been used to develop commonly abused prescription medications in an abuse-deterrent form. Egalet's proprietary Guardian Technology is a polymer matrix tablet technology that utilizes a novel application of the well characterized manufacturing process of injection molding. The process results in tablets with controlled-release properties as well as physical and chemical features that have been demonstrated to resist both common and rigorous methods of manipulation.

Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain and other conditions.