DAYVIGO Drug Patent Profile

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Which patents cover Dayvigo, and what generic alternatives are available?

Dayvigo is a drug marketed by Eisai Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in DAYVIGO is lemborexant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lemborexant profile page.

DrugPatentWatch^® Generic Entry Outlook for Dayvigo

Dayvigo was eligible for patent challenges on April 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 21, 2035. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for DAYVIGO

US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	100
Drug Prices:	Drug price information for DAYVIGO
What excipients (inactive ingredients) are in DAYVIGO?	DAYVIGO excipients list
DailyMed Link:	DAYVIGO at DailyMed

See drug prices for DAYVIGO

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

Constraining patent/regulatory exclusivity:

10,702,529

NDA:

212028

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 DAYVIGO

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

Sponsor	Phase
Eisai Inc.	Phase 2
Brendan Lucey	Phase 2
Eisai Co., Ltd.	Phase 2

See all DAYVIGO clinical trials

Pharmacology for DAYVIGO

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2B6 Inducers Orexin Receptor Antagonists

Paragraph IV (Patent) Challenges for DAYVIGO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DAYVIGO	Tablets	lemborexant	5 mg	212028	1	2026-07-14

US Patents and Regulatory Information for DAYVIGO

DAYVIGO is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 10,702,529.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	8,268,848		Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	8,268,848		Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	10,702,529		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	10,702,529		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	10,188,652		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	11,026,944		Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	10,188,652		Y

International Patents for DAYVIGO

When does loss-of-exclusivity occur for DAYVIGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

Singapore

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DAYVIGO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2015336463
Brazil	112017007063
Canada	2964504	FORME DE DOSE ORALE COMPRENANT UN DERIVE DE CYCLOPROPANECARBOXAMIDE POURUTILISATION DANS LE TRAITEMENT DE L'INSOMNIE (ORAL DOSAGE FORM COMPRISING A CYCLOPROPANECARBOXAMIDE DERIVATIVE FOR USE IN TREATING INSOMNIA)
China	107810006	用于治疗失眠的组合物 (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
European Patent Office	3209298	COMPOSITIONS ET MÉTHODES POUR TRAITER L'INSOMNIE (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Spain	2843952
Israel	251759	תכשירים ושיטות לטיפול בנדודי שינה (Compositions and methods for treating insomnia)

DrugChatter Q&A for DAYVIGO

Dayvigo mechanism of action?
Dayvigo 5 mg?
What is dayvigo similar to?
Dayvigo for sleep?
Dayvigo mexico?