Suvorexant - Generic Drug Details

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What are the generic drug 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 three 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:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	61
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

Generic Entry Date for suvorexant^: ⤷ 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 suvorexant

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

Sponsor	Phase
Medical University of South Carolina	Phase 4
University of Maryland, Baltimore	Phase 2
Johns Hopkins University	Early Phase 1

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

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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
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-004	Aug 13, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-003	Aug 13, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-001	Aug 13, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Merck Sharp Dohme	BELSOMRA	suvorexant	TABLET;ORAL	204569-002	Aug 13, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ 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 suvorexant

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Country	Patent Number	Title	Estimated Expiration
Chile	2007003441	COMPUESTOS DERIVADOS DE 1,4-DIAZEPAM SUSTITUIDO, ANTAGONISTAS DEL RECEPTOR DE OREXINA; COMPOSICION FARMACEUTICA; Y USO PARA EL TRATAMIENTO O PREVENCION DE UN TRASTORNO DEL SUENO, PARA POTENCIAR LA CALIDAD DEL SUENO, Y PARA TRATAR O CONTROLAR LA OBESI	⤷ Sign Up
Ukraine	106873	СПОЛУКИ ЗАМІЩЕНИХ ДІАЗЕПАНІВ ЯК АНТАГОНІСТИ ОРЕКСИНОВИХ РЕЦЕПТОРІВ	⤷ Sign Up
Taiwan	I515188		⤷ Sign Up
Japan	2015518867		⤷ Sign Up
South Korea	102123130		⤷ Sign Up
Cyprus	1113798		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013181174		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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