DARIDOREXANT HYDROCHLORIDE - Generic Drug Details

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:	10
Patent Applications:	9
DailyMed Link:	DARIDOREXANT HYDROCHLORIDE at DailyMed

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

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
Idorsia Pharmaceuticals Ltd.	Phase 4
Idorsia Pharmaceuticals Ltd.	Phase 2
Idorsia Pharmaceuticals Ltd.	Phase 1

See all DARIDOREXANT HYDROCHLORIDE clinical trials

Pharmacology for DARIDOREXANT HYDROCHLORIDE

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Orexin Receptor Antagonists

US Patents and Regulatory Information for DARIDOREXANT HYDROCHLORIDE

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	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-002	Apr 7, 2022		RX	Yes	Yes			Y	Y
Idorsia	QUVIVIQ	daridorexant hydrochloride	TABLET;ORAL	214985-001	Apr 7, 2022		RX	Yes	No			Y	Y

International Patents for DARIDOREXANT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Slovenia	3077390
Taiwan	201400476	Benzimidazole-proline derivatives
Japan	2016539135	オレキシン受容体アンタゴニストとしての（Ｓ）−（２−（６−クロロ−７−メチル−１Ｈ−ベンゾ［Ｄ］イミダゾール−２−イル）−２−メチルピロリジン−１−イル）（５−メトキシ−２−（２Ｈ−１，２，３−トリアゾール−２−イル）フェニル）メタノンの塩結晶形
Argentina	091257	DERIVADOS DE BENCIMIDAZOL-PROLINA
Australia	2013273222	Benzimidazole-proline derivatives

Supplementary Protection Certificates for DARIDOREXANT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2855453	2022C/543	Belgium		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	36/2022	Austria		PRODUCT NAME: DARIDOREXANT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DARIDOREXANTHYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1638 (MITTEILUNG) 20220502
2855453	301197	Netherlands		PRODUCT NAME: DARIDOREXANT OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER DARIDOREXANTHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1638 20220502
2855453	C202230046	Spain		PRODUCT NAME: DARIDOREXANT O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, EN PARTICULAR DARIDOREXANT HIDROCLORURO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1638; DATE OF AUTHORISATION: 20220429; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1638; DATE OF FIRST AUTHORISATION IN EEA: 20220429
2855453	LUC00279	Luxembourg		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