DrugPatentWatch Database Preview
WAKIX Drug Profile
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When do Wakix patents expire, and what generic alternatives are available?
Wakix is a drug marketed by Harmony and is included in one NDA. There are five patents protecting this drug.
This drug has eighty-five patent family members in thirty-three countries.
The generic ingredient in WAKIX is pitolisant hydrochloride. Additional details are available on the pitolisant hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Wakix
Wakix will be eligible for patent challenges on August 14, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 25, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for WAKIX
| International Patents: | 85 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Bulk Api Vendors: | 47 |
| Patent Applications: | 100 |
| Drug Prices: | Drug price information for WAKIX |
| What excipients (inactive ingredients) are in WAKIX? | WAKIX excipients list |
| DailyMed Link: | WAKIX at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for WAKIX
Generic Entry Date for WAKIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
US Patents and Regulatory Information for WAKIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for WAKIX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | Start Trial | Start Trial |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for WAKIX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2007009574 | Start Trial |
| Japan | 2008530050 | Start Trial |
| Cyprus | 1114636 | Start Trial |
| Norway | 20075086 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for WAKIX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1428820 | 2016/038 | Ireland | Start Trial | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | CR 2016 00042 | Denmark | Start Trial | PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404 |
| 1428820 | 499 | Finland | Start Trial | |
| 1428820 | SPC/GB16/052 | United Kingdom | Start Trial | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
