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Last Updated: March 28, 2024

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QUVIVIQ Drug Patent Profile


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When do Quviviq patents expire, and when can generic versions of Quviviq launch?

Quviviq is a drug marketed by Idorsia and is included in one NDA. There are three patents protecting this drug.

This drug has eighty-eight patent family members in thirty-five countries.

The generic ingredient in QUVIVIQ is daridorexant hydrochloride. One supplier is listed for this compound. Additional details are available on the daridorexant hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Quviviq

Quviviq will be eligible for patent challenges on April 7, 2026. 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 December 2, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for QUVIVIQ
International Patents:88
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 3
Clinical Trials: 1
Patent Applications: 5
Drug Prices: Drug price information for QUVIVIQ
What excipients (inactive ingredients) are in QUVIVIQ?QUVIVIQ excipients list
DailyMed Link:QUVIVIQ at DailyMed
Drug patent expirations by year for QUVIVIQ
Drug Prices for QUVIVIQ

See drug prices for QUVIVIQ

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QUVIVIQ
Generic Entry Date for QUVIVIQ*:
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.

Recent Clinical Trials for QUVIVIQ

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Idorsia Pharmaceuticals Ltd.Phase 1

See all QUVIVIQ clinical trials

Pharmacology for QUVIVIQ
Anatomical Therapeutic Chemical (ATC) Classes for QUVIVIQ

US Patents and Regulatory Information for QUVIVIQ

QUVIVIQ is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of QUVIVIQ is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting QUVIVIQ

Crystalline salt form of (S)-(2-(6 chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-yl)(5-meth- oxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

Benzimidazole-proline derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF INSOMNIA

Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1H-benzo[d]imidazol-2-yl)-2-methylpyrrolidin-1-- yl)(5-methoxy-2-(2H-1,2,3-triazol-2-yl)phenyl)methanone as orexin receptor antagonist
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting QUVIVIQ

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Idorsia QUVIVIQ daridorexant hydrochloride TABLET;ORAL 214985-001 Apr 7, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Idorsia QUVIVIQ daridorexant hydrochloride TABLET;ORAL 214985-002 Apr 7, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Idorsia QUVIVIQ daridorexant hydrochloride TABLET;ORAL 214985-001 Apr 7, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Idorsia QUVIVIQ daridorexant hydrochloride TABLET;ORAL 214985-002 Apr 7, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Idorsia QUVIVIQ daridorexant hydrochloride TABLET;ORAL 214985-001 Apr 7, 2022 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for QUVIVIQ

When does loss-of-exclusivity occur for QUVIVIQ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 14358743
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2016012625
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 29720
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 16001348
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5793258
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0171772
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19687
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 0109
Estimated Expiration: ⤷  Try a Trial

Patent: 1600436
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 25736
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 34656
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 5922
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 91716
Estimated Expiration: ⤷  Try a Trial

Patent: 16539135
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 6244
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2701
Estimated Expiration: ⤷  Try a Trial

Patent: 16007216
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 164
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1493
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 016500989
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

Saudi Arabia

Patent: 6371248
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201604541W
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 77390
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1604501
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1839716
Estimated Expiration: ⤷  Try a Trial

Patent: 160093683
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 51508
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 36982
Estimated Expiration: ⤷  Try a Trial

Patent: 1605839
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 9151
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering QUVIVIQ around the world.

Country Patent Number Title Estimated Expiration
Singapore 10201702540U BENZIMIDAZOLE-PROLINE DERIVATIVES ⤷  Try a Trial
Malaysia 176244 CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1H-BENZO[D]IMIDAZOL-2-YL)-2-METHYLPYRROLIDIN-1-YL)(5-METHOXY-2-(2H-1,2,3-TRIAZOL-2-YL)PHENYL)METHANONE AS OREXIN RECEPTOR ANTAGONIST ⤷  Try a Trial
Morocco 20150282 Dérivés de benzimidazole-proline ⤷  Try a Trial
Morocco 39164 Forme de sel cristalline de (s)-(2-(6-chloro-7-méthyl-1 h-benzo[d]imidazol- 2-yl)-2-méthylpyrrolidin-1-yl)(5-méthoxy-2-(2h-1,2,3-triazol-2-yl)phényl)méthanone comme antagoniste des récepteurs à l'oréxine ⤷  Try a Trial
Portugal 2855453 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for QUVIVIQ

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2855453 CA 2022 00041 Denmark ⤷  Try a Trial PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502
2855453 2022C/543 Belgium ⤷  Try a Trial PRODUCT NAME: DARIDOREXANT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; AUTHORISATION NUMBER AND DATE: EU/1/22/1638 20220502
2855453 301197 Netherlands ⤷  Try a Trial PRODUCT NAME: DARIDOREXANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER DARIDOREXANTHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1638 20220502
2855453 LUC00279 Luxembourg ⤷  Try a Trial PRODUCT NAME: DARIDOREXANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE CHLORHYDRATE DE DARIDOREXANT; AUTHORISATION NUMBER AND DATE: EU 1/22/1638 20220502
2855453 C02855453/01 Switzerland ⤷  Try a Trial PRODUCT NAME: DARIDOREXANTUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68481 01.12.2022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.