Jazz Pharmaceuticals sues 10 generic filers over Epidiolex patents; seeks 30-month stay

Jazz Pharmaceuticals plc

10 ANDA filers, including Teva, Padagis, Apotex, Lupin, Taro, and others, filed paragraph IV certifications for generic Epidiolex.
Jazz filed patent infringement suit on January 3, 2023 in District of New Jersey.
Lawsuit seeks FDA approval no earlier than expiration of last asserted patent; triggers automatic 30-month stay.
Epidiolex has Orphan Drug Exclusivity for LGS/Dravet through Sept 2025 (ages 2+) and July 2027 (ages 1-2 and TSC).
No other ANDA filers identified as of filing date.

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