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 2023-08-15.
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
(6 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
(2 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: 2023-08-15
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
WAKIX family patents
6
United States
5
European Union
4
Japan
2
ME
2
Poland
2
Canada
2
Slovenia
2
Korea, Republic of
2
China
2
RS
2
Germany
2
Denmark
2
Croatia
2
Spain
2
Mexico
2
Austria
2
Portugal
2
Cyprus
1
Ukraine
1
Brazil
1
Taiwan
1
Morocco
1
IB
1
Argentina
1
Uruguay
1
New Zealand
1
EA
1
Australia
1
Norway
1
South Africa
1
Tunisia
1
Singapore
900+ leading pharmaceutical companies are staying up-to-date with drug patents through Pharsight
Join them to stay ahead in capturing the next drug going generic