Lupin Concedes To Harmony On Generic Wakix With 2030 Launch Agreement

Lupin became the latest ANDA sponsor to settle patent-infringement litigation over Harmony Biosciences’ Wakix (pitolisant hydrochloride), which has been touted as a potential blockbuster.

Lupin will be allowed to launch its generic Wakix in January 2030 or July 2023 if pediatric exclusivity is included. (Shutterstock)
Key Takeaways
  • Lupin settled US patent-infringement litigation with Harmony Biosciences over its proposed generic Wakix (pitolisant hydrochloride).

Lupin must wait until at least January 2030 to launch its proposed generic of

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