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
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 |
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
Sponsor | Phase |
---|---|
Idorsia Pharmaceuticals Ltd. | Phase 1 |
Pharmacology for QUVIVIQ
Drug Class | Orexin Receptor Antagonist |
Mechanism of Action | Orexin Receptor Antagonists |
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 |