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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for QUVIVIQ
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF INSOMNIA
Benzimidazole-proline derivatives
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting QUVIVIQ
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Idorsia | QUVIVIQ | daridorexant hydrochloride | TABLET;ORAL | 214985-002 | Apr 7, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Idorsia | QUVIVIQ | daridorexant hydrochloride | TABLET;ORAL | 214985-001 | Apr 7, 2022 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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
Patent: Crystalline salt form of (S)-(2-(6-chloro-7-methyl-1 H-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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2016012625
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 29720
Patent: FORME DE SEL CRISTALLINE DE (S)-(2-(6-CHLORO-7-METHYL-1 H-BENZO[D]IMIDAZOL- 2-YL)-2-METHYLPYRROLIDIN-1-YL)(5-METHOXY-2-(2H-1,2,3-TRIAZOL-2-YL)PHENYL)METHANONE COMME ANTAGONISTE DES RECEPTEURS A L'OREXINE (CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 16001348
Patent: Forma cristalina de clorhidrato de (s)-(2-(6-cloro-7-metil-1h-benzo[d]imidazol-2-il)-2-metilpirrolidin-1-il)(5-metoxi-2-(2h-1,2,3-triazol-2-il)fenil)metanona; composición farmacéutica que la comprende; y su uso para el tratamiento o prevención de trastornos del sueño, tales como disomnias, parasomnias, entre otras.
Estimated Expiration: ⤷ Sign Up
China
Patent: 5793258
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0171772
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 19687
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 77390
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0109
Patent: КРИСТАЛЛИЧЕСКАЯ СОЛЕВАЯ ФОРМА (S)-(2-(6-ХЛОР-7-МЕТИЛ-1H-БЕНЗО[d]ИМИДАЗОЛ-2-ИЛ)-2-МЕТИЛПИРРОЛИДИН-1-ИЛ)(5-МЕТОКСИ-2-(2H-1,2,3-ТРИАЗОЛ-2-ИЛ)ФЕНИЛ)МЕТАНОНА И ЕЕ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВОГО РЕЦЕПТОРА (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 AND USE THEREOF AS OREXIN RECEPTOR ANTAGONISTS)
Estimated Expiration: ⤷ Sign Up
Patent: 1600436
Patent: КРИСТАЛЛИЧЕСКАЯ СОЛЕВАЯ ФОРМА (S)-(2-(6-ХЛОР-7-МЕТИЛ-1H-БЕНЗО[D]ИМИДАЗОЛ-2-ИЛ)-2-МЕТИЛПИРРОЛИДИН-1-ИЛ)(5-МЕТОКСИ-2-(2H-1,2,3-ТРИАЗОЛ-2-ИЛ)ФЕНИЛ)МЕТАНОНА И ЕЕ ПРИМЕНЕНИЕ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВОГО РЕЦЕПТОРА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 77390
Patent: 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 (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)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 25736
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 34656
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5922
Patent: צורת מלח גבישית של (s)-(2-(6-כלורו-7-מתיל-1h-בנזו[d]אימידאזול-2-איל)-2-מתילפירולידין-1-איל)(5-מתוקסי-2-(2h-3,2,1-טריאזול-2-איל)פניל)מתאנון כאנטגוניסטים לקולטן אורקסין (Crystalline salt form of (s)-(2-(6-chloro-7-methyl-1 h-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)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 91716
Estimated Expiration: ⤷ Sign Up
Patent: 16539135
Patent: オレキシン受容体アンタゴニストとしての（Ｓ）−（２−（６−クロロ−７−メチル−１Ｈ−ベンゾ［Ｄ］イミダゾール−２−イル）−２−メチルピロリジン−１−イル）（５−メトキシ−２−（２Ｈ−１，２，３−トリアゾール−２−イル）フェニル）メタノンの塩結晶形
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 77390
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 6244
Patent: 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
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2701
Patent: FORMA DE SAL CRISTALINA DE (S)-(2-(6-CLORO-7-METIL-1H-BENZO[D]IMID AZOL-2-IL)-2-METIL-PIRROLIDIN-1-IL)(5-METOXI-2-(2H-1,2,3-TRIAZOL- 2-IL)FENIL)METANONA COMO ANTAGONISTA DE RECEPTOR DE OREXINA. (CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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.)
Estimated Expiration: ⤷ Sign Up
Patent: 16007216
Patent: FORMA DE SAL CRISTALINA DE (S)-(2-(6-CLORO-7-METIL-1H-BENZO[D]IMID AZOL-2-IL)-2-METIL-PIRROLIDIN-1-IL) (5-METOXI-2-(2H-1,2,3-TRIAZOL- 2-IL)FENIL) METANONA COMO ANTAGONISTAS DE RECEPTOR DE OREXINA. (CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 164
Patent: 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
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 1493
Patent: 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
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 77390
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 016500989
Patent: CRYSTALLINE 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 ANTAGONISTS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 77390
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 77390
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 6371248
Patent: صورة ملح متبلورة من (s)-(2-(6-كلورو-7-ميثيل-1h-بنزو[d]إميدازول-2-يل)-2-ميثيل بيروليدين-1-يل)(5-ميثوكسي-2-(2h-1، 2، 3-تريازول-2-يل)فينيل)ميثانون كمضادات مستقبل أوريكسين (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-L)phenyl)methanone as orexin receptor antagonist)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201604541W
Patent: CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 77390
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1604501
Patent: CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1839716
Estimated Expiration: ⤷ Sign Up
Patent: 160093683
Patent: 오렉신 수용체 길항제로서의 (Ｓ)-(２-(６-클로로-７-메틸-１Ｈ-벤조[Ｄ]이미다졸-２-일)-２-메틸피롤리딘-１-일)(５-메톡시-２-(２Ｈ-１,２,３-트리아졸-２-일)페닐)메타논의 결정성 염 형태 (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)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 51508
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 36982
Estimated Expiration: ⤷ Sign Up
Patent: 1605839
Patent: Crystalline salt form
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9151
Patent: КРИСТАЛІЧНА СОЛЬОВА ФОРМА (S)-(2-(6-ХЛОР-7-МЕТИЛ-1H-БЕНЗО[d]ІМІДАЗОЛ-2-ІЛ)-2-МЕТИЛПІРОЛІДИН-1-ІЛ)(5-МЕТОКСИ-2-(2H-1,2,3-ТРИАЗОЛ-2-ІЛ)ФЕНІЛ)МЕТАНОНУ ЯК АНТАГОНІСТ ОРЕКСИНОВОГО РЕЦЕПТОРА (CRYSTALLINE SALT FORM OF (S)-(2-(6-CHLORO-7-METHYL-1 H-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)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| South Korea | 101839716 | ⤷ Sign Up | |
| Lithuania | 3077390 | ⤷ Sign Up | |
| Spain | 2617863 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for QUVIVIQ
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2855453 | LUC00279 | Luxembourg | ⤷ Sign Up | 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 | 2022C/543 | Belgium | ⤷ Sign Up | 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 | C02855453/01 | Switzerland | ⤷ Sign Up | 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.
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