DARIDOREXANT HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for daridorexant hydrochloride and what is the scope of freedom to operate?

Daridorexant hydrochloride is the generic ingredient in one branded drug marketed by Idorsia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Daridorexant hydrochloride has eighty-eight patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for DARIDOREXANT HYDROCHLORIDE

International Patents:	88
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	12
Patent Applications:	9
DailyMed Link:	DARIDOREXANT HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DARIDOREXANT HYDROCHLORIDE

Generic Entry Date for DARIDOREXANT HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Recent Clinical Trials for DARIDOREXANT HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Berry Consultants	Phase 2
Citeline	Phase 2
U.S. Army Medical Research and Development Command	Phase 2

See all DARIDOREXANT HYDROCHLORIDE clinical trials

Pharmacology for DARIDOREXANT HYDROCHLORIDE

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DARIDOREXANT HYDROCHLORIDE

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for DARIDOREXANT HYDROCHLORIDE

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Glossary

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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	214985-002	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	Y	Y		⤷ Sign Up
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes	⤷ 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 DARIDOREXANT HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
South Korea	101839716		⤷ Sign Up
Lithuania	3077390		⤷ Sign Up
Spain	2617863		⤷ Sign Up
Taiwan	201600517	Benzimidazole-proline derivatives	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for DARIDOREXANT HYDROCHLORIDE

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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
2855453	CA 2022 00041	Denmark	⤷ Sign Up	PRODUCT NAME: DARIDOREXANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SAERLIGT DARIDOREXANT HYDROCHLORID; REG. NO/DATE: EU/1/22/1638 20220502
>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.