List of Wakix drug patents
Wakix is owned by Harmony.
Wakix contains Pitolisant Hydrochloride.
Wakix has a total of 3 drug patents out of which 0 drug patents have expired.
Wakix was authorised for market use on 14 August, 2019.
Wakix is available in tablet;oral dosage forms.
Wakix can be used as method of treating excessive daytime sleepiness in patients with narcolepsy; method of treating cataplexy in patients with narcolepsy.
Drug patent challenges can be filed against Wakix from August, 2023.
The generics of Wakix are possible to be released after 07 March, 2030.
| Patent Number | Company | Patent Title | Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These patents protects the active chemical substance. Only patent owner can launch products that use this active substance. | ||||
| US8207197 | HARMONY | Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine |
Mar, 2030
(7 years from now) | |
| These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US8354430 | HARMONY | Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine |
Feb, 2026
(3 years from now) | |
| US8486947 | HARMONY | Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands |
Sep, 2029
(6 years from now) | |
| Exclusivity | Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity (NCE) | Aug 14, 2024 |
| Orphan Drug Exclusivity (ODE) | Oct 13, 2027 |
| New Indication (I) | Oct 13, 2023 |
Drugs and Companies using PITOLISANT HYDROCHLORIDE ingredient
NCE-1 date: August, 2023
Market Authorisation Date: 14 August, 2019
Treatment: Method of treating excessive daytime sleepiness in patients with narcolepsy; Method of treating cataplexy in patients with narcolepsy
Dosage: TABLET;ORAL
availability in other generic markets.
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