Sodium oxybate – USA
On Feb. 24, 2023, Federal Circuit affirmed district court’s decision for delisting of REMS patent of Xyrem®.
Jazz holds NDA for the narcolepsy drug Xyrem (Sodium oxybate). U.S. 8,731,963 is listed in orange book which claims single-pharmacy distribution system, which controls access to abuse-prone prescription drugs. In 2017, three of the ’963 patent’s 28 claims were found unpatentable in IPR proceeding. The remaining claims expired in December 2022. Because Jazz received a grant of …