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. 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. 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
*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 | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF INSOMNIA | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jun 12, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF INSOMNIA | ||||||||
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