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Last Updated: January 26, 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-three patent family members in thirty-three countries.

The generic ingredient in WAKIX is pitolisant hydrochloride. One supplier is listed for this compound. 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:83
US Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 40
Patent Applications: 19
DailyMed Link:WAKIX at DailyMed
Drug patent expirations by year 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.

Synonyms for WAKIX
1-(3-(3-(4-Chlorophenyl)propoxy)propyl)piperidine
1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine
1-[3-[3-(4-Chlorophenyl)propoxy]propyl]-piperidinehydrochloride
1-[3-[3-(4-chlorophenyl)propoxy]propyl]piperidine
1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine
3-(4-Chlorophenyl)propyl 3-piperidinopropyl ether
362665-56-3
3973AH
4BC83L4PIY
AKOS028108820
API0014072
BCP13114
BDBM50247053
BF2.649
CHEBI:134709
CHEMBL462605
CS-0666
CTK1B6404
D10749
DTXSID30957654
GTPL8924
HBS-101
HMS3743C05
HY-12199
KS-000002GS
MFCD18782650
NNACHAUCXXVJSP-UHFFFAOYSA-N
Piperidine, 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-
Pitolisant
Pitolisant (BF2.649)
Pitolisant (USAN/INN)
Pitolisant [USAN:INN]
SB17037
SCHEMBL117648
TIPROLISANT
tiprolisant [USAN]
Tirolisant
UNII-4BC83L4PIY
W-5790
Wakix (TN)
ZINC34045468

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
>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 16C0038 France   Start Trial PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
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
1428820 1690039-1 Sweden   Start Trial PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
Medtronic
Express Scripts
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Dow

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