Last Updated: November 8, 2026

Harmony Company Profile

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What is the competitive landscape for HARMONY

HARMONY has one approved drug.

There are three US patents protecting HARMONY drugs.

Summary for Harmony
US Patents:3
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Harmony

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 211150-002 Aug 14, 2019 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 AB RX Yes No ⤷  Start Trial ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 AB RX Yes No ⤷  Start Trial ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 AB RX Yes No 8,207,197 ⤷  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

Expired US Patents for Harmony

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 7,169,928 ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 8,354,430 ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 7,910,605 ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 7,169,928 ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 8,354,430 ⤷  Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 7,910,605 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for Harmony Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 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 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 1690039-1 Sweden ⤷  Start Trial PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 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 40/2016 Austria ⤷  Start Trial PRODUCT NAME: PITOLISANT UND SEINE PHARMAZEUTISCH VERTRAEGLICHEN SALZE EINSCHLIESSLICH DEM HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 (MITTEILUNG) 20160404
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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