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Last Updated: July 7, 2020

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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-four 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.

US ANDA Litigation and 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

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Summary for WAKIX
International Patents:84
US Patents:5
Applicants:1
NDAs:1
Bulk Api Vendors: 42
Patent Applications: 20
Drug Prices: Drug price information for WAKIX
DailyMed Link:WAKIX at DailyMed
Drug patent expirations by year for WAKIX
Drug Prices for WAKIX

See drug prices for WAKIX

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 211150-001 Aug 14, 2019 RX Yes No   Start Trial   Start Trial   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 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

Supplementary Protection Certificates for WAKIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 300832 Netherlands   Start Trial PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820 499 Finland   Start Trial
1428820 93229 Luxembourg   Start Trial PRODUCT NAME: ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H-3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES, FIRST REGISTRATION DATE: 20160404
1428820 2016C/048 Belgium   Start Trial PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Harvard Business School
McKesson
Boehringer Ingelheim
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.