Details for New Drug Application (NDA): 214985
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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.
Summary for 214985
Tradename: | QUVIVIQ |
Applicant: | Idorsia |
Ingredient: | daridorexant hydrochloride |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214985
Generic Entry Date for 214985*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 214985
Mechanism of Action | Orexin Receptor Antagonists |
Suppliers and Packaging for NDA: 214985
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
QUVIVIQ | daridorexant hydrochloride | TABLET;ORAL | 214985 | NDA | Idorsia Pharmaceuticals Ltd | 80491-7825 | 80491-7825-2 | 1 BLISTER PACK in 1 CARTON (80491-7825-2) / 7 TABLET, FILM COATED in 1 BLISTER PACK |
QUVIVIQ | daridorexant hydrochloride | TABLET;ORAL | 214985 | NDA | Idorsia Pharmaceuticals Ltd | 80491-7825 | 80491-7825-3 | 1 BOTTLE in 1 CARTON (80491-7825-3) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Apr 7, 2022 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 7, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Sep 30, 2027 | ||||||||
Regulatory Exclusivity Use: | REVISIONS TO THE CLINICAL STUDIES SECTION TO REFLECT THE RESULTS OF A CLINICAL STUDY TO FULFILL POST-MARKETING REQUIREMENT 4150-1 | ||||||||
Patent: | 10,023,560 | Patent Expiration: | Dec 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA |
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