Details for New Drug Application (NDA): 214985
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NDA 214985 describes QUVIVIQ, which is a drug marketed by Idorsia and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the QUVIVIQ profile page.
The generic ingredient in QUVIVIQ is daridorexant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the daridorexant hydrochloride profile page.
The generic ingredient in QUVIVIQ is daridorexant hydrochloride. There is one drug master file entry for this compound. 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: | Sep 30, 2027 | ||||||||
| Regulatory Exclusivity Use: | CLINICAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE LABELING. | ||||||||
| 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 | ||||||||
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