Harmony settles Lupin ANDA litigation; generic WAKIX entry delayed to 2030

Harmony Biosciences Holdings, Inc.

Lupin receives license to launch generic WAKIX no earlier than January 2030 (July 2030 with pediatric exclusivity).
Litigation in U.S. District Court for Delaware dismissed as part of the agreement.
Harmony will continue patent infringement litigation against other ANDA filers seeking generic WAKIX.
U.S. Patent Office PTAB previously declined to institute reexamination of Harmony's polymorph patent, affirming its validity.
Harmony is developing next-generation pitolisant formulations with patents extending potential exclusivity to 2044.

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