Generic Quviviq Availability
Last updated on Apr 10, 2025.
Quviviq is a brand name of daridorexant, approved by the FDA in the following formulation(s):
QUVIVIQ (daridorexant hydrochloride - tablet;oral)
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Manufacturer: IDORSIA
Approval date: April 7, 2022
Strength(s): EQ 25MG BASE [RLD], EQ 50MG BASE [RLD]
Is there a generic version of Quviviq available?
No. There is currently no therapeutically equivalent version of Quviviq available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Quviviq. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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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 10,023,560
Issued: July 17, 2018
Inventor(s): Boss Christoph & Brotschi Christine & Gude Markus & Heidmann Bibia & Sifferlen Thierry & Von Raumer Markus & Williams Jodi T.
Assignee(s): IDORSIA PHARMACEUTICALS LTDThe invention relates to a 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 hydrochloride, processes for the preparation thereof, pharmaceutical compositions containing said crystalline form, and its use as medicament, especially as orexin receptor antagonist.
Patent expiration dates:
- December 2, 2034✓
- December 2, 2034
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Benzimidazole-proline derivatives
Patent 9,732,075
Issued: August 15, 2017
Inventor(s): Boss Christoph & Brotschi Christine & Gude Markus & Heidmann Bibia & Sifferlen Thierry & Williams Jodi
Assignee(s): IDORSIA PHARMACEUTICALS LTDThe present invention relates to compounds of the formula (I)
Patent expiration dates:
- June 12, 2033✓✓✓
- June 12, 2033
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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 9,790,208
Issued: October 17, 2017
Inventor(s): Boss Christoph & Brotschi Christine & Gude Markus & Heidmann Bibia & Sifferlen Thierry & Von Raumer Markus & Williams Jodi T.
Assignee(s): IDORSIA PHARMACEUTICALS LTDThe invention relates to a 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 hydrochloride, processes for the preparation thereof, pharmaceutical compositions containing said crystalline form, and its use as medicament, especially as orexin receptor antagonist.
Patent expiration dates:
- December 2, 2034✓✓
- December 2, 2034
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- April 7, 2027 - NEW CHEMICAL ENTITY
- September 30, 2027 - CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING.
- September 30, 2027 - REVISIONS TO THE CLINICAL STUDIES SECTION TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST-MARKETING REQUIREMENT 4150-1
More about Quviviq (daridorexant)
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- Drug class: miscellaneous anxiolytics, sedatives and hypnotics
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
