Jazz Pharmaceuticals filed a patent infringement suit against Lupin in the U.S. District Court for the District of New Jersey.
- The complaint alleges that by Lupin filing its ANDA, the company has infringed ten of the company’s Orange Book listed patents, seeking a permanent injunction to prevent Lupin from introducing a generic version of Xywav
- Company expects that a stay of approval of up to 30 months will be imposed by FDA on Lupin’s ANDA
- As recently recognized by FDA, Xywav also has Orphan Drug Exclusivity through July 21, 2027
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