Suvorexant - Generic Drug Details

What are the generic sources for suvorexant and what is the scope of patent protection?

Suvorexant is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Suvorexant has seventy-five patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for suvorexant

International Patents:	75
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	60
Patent Applications:	464
What excipients (inactive ingredients) are in suvorexant?	suvorexant excipients list
DailyMed Link:	suvorexant at DailyMed

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

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 suvorexant

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

Sponsor	Phase
University of Maryland, Baltimore	Phase 2
Johns Hopkins University	Early Phase 1
Columbia University	Phase 4

See all suvorexant clinical trials

Pharmacology for suvorexant

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 3A Inhibitors Orexin Receptor Antagonists P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for suvorexant

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

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for SUVOREXANT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELSOMRA	Tablets	suvorexant	5 mg, 10 mg, 15 mg and 20 mg	204569	1	2024-03-04

US Patents and Regulatory Information for suvorexant

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y	Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No			Y
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes			Y

International Patents for suvorexant

Country	Patent Number	Title	Estimated Expiration
Argentina	088881	UNA COMPOSICION FARMACEUTICA QUE COMPRENDE 5-CLORO-2-{(5R)-5-METIL-4-[5-METIL-2-(2H-1,2,3-TRIAZOL-2-IL)BENZOIL]-1,4-DIAZEPAN-1-IL}-1,3-BENZOXAZOL; O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO Y SU USO EN LA PREPARACION DE MEDICAMENTOS
Russian Federation	2009125024	СОЕДИНЕНИЯ ЗАМЕЩЕННЫХ ДИАЗЕПАНОВ В КАЧЕСТВЕ АНТАГОНИСТОВ ОРЕКСИНОВЫХ РЕЦЕПТОРОВ
Hong Kong	1128691	SUBSTITUTED DIAZEPAN COMPOUNDS AS OREXIN RECEPTOR ANTAGONISTS
China	101880276	Substituted diazepan compounds as orexin receptor antagonists
Portugal	2089382
South Korea	101299426