drug · small molecule
pitolisant hydrochloride
Marketedupdated 3mo agoby $HRMY Harmony Biosciences Holdings, Inc.🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 3Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for 3 indications.
targets
Histamine H3 receptor
all catalysts(6)
approval · 6
Aug 14, 2019
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
Oct 13, 2020
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
Dec 22, 2022
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
Jun 21, 2024
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
May 23, 2025
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
Feb 13, 2026
approval
$HRMY38.07-4.66%
WAKIX (PITOLISANT HYDROCHLORIDE) — FDA approval
pitolisant hydrochloride
→
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 21, 2027
304 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (6)
- Mar 7, 2030compositionUS 82071973.5y
- Mar 7, 2030compositionUS 82071973.5y
- Sep 26, 2029method-of-use (U-1102)US 84869473.1y
- Sep 26, 2029method-of-use (U-1102)US 84869473.1y
- Feb 6, 2026method-of-use (U-1102)US 8354430
- Feb 6, 2026method-of-use (U-1102)US 8354430
FDA exclusivities (8)
- Jun 21, 2031ODE-489Orphan Drug (7y)4.8y
- Jun 21, 2031ODE-489Orphan Drug (7y)4.8y
- Oct 13, 2027ODE-331Orphan Drug (7y)1.1y
- Oct 13, 2027ODE-331Orphan Drug (7y)1.1y
- Jun 21, 2027NPPNew Product (3y)304d
- Jun 21, 2027NPPNew Product (3y)304d
- Aug 14, 2026ODE-255Orphan Drug (7y)
- Aug 14, 2026ODE-255Orphan Drug (7y)
News(2)
- Takeda leads wave of orexin drugs with potential to upend narcolepsy marketThe FDA’s August approval of Takeda’s Orzeyful for treating the full set of narcolepsy symptoms initiated a new era in the sleep market.biospace · 1d ago
- Takeda’s narcolepsy nod opens orexin doorsOrzeyful is the first orexin agonist cleared by the FDA, and is the first narcolepsy therapy that addresses the full host of disease symptoms. It is "likely to reshape the treatment paradigm” for t…biospace · 14d ago
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