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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.

This drug has fifty-three patent family members in thirty-two countries.

The generic ingredient in DAYVIGO is lemborexant. 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.

Indicators of Generic Entry

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Summary for DAYVIGO

International Patents:	53
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	7
Patent Applications:	35
Drug Prices:	Drug price information for DAYVIGO
What excipients (inactive ingredients) are in DAYVIGO?	DAYVIGO excipients list
DailyMed Link:	DAYVIGO at DailyMed

Drug patent expirations by year for DAYVIGO

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

Generic Entry Date for DAYVIGO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Brendan Lucey	Phase 2
Eisai Inc.	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

US Patents and Regulatory Information for DAYVIGO

DAYVIGO is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAYVIGO is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DAYVIGO

Compositions and methods for treating insomnia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE

Compositions and methods for treating insomnia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Cyclopropane compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE

FDA Regulatory Exclusivity protecting DAYVIGO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113
Exclusivity Expiration: ⤷ Sign Up

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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
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	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 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

Patent: 15336463
Patent: Compositions and methods for treating insomnia
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2017007063
Patent: ?composições e métodos para o tratamento de insônia?
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 64504
Patent: 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)
Estimated Expiration: ⤷ Sign Up

China

Patent: 7810006
Patent: 用于治疗失眠的组合物和方法 (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 09298
Patent: COMPOSITIONS ET MÉTHODES POUR TRAITER L'INSOMNIE (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 1759
Patent: תכשירים ושיטות לטיפול בנדודי שינה (Compositions and methods for treating insomnia)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 59681
Estimated Expiration: ⤷ Sign Up

Patent: 17531683
Patent: 不眠症を治療するための組成物および方法
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 17004950
Patent: COMPOSICIONES Y METODOS PARA TRATAR EL INSOMNIO. (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA.)
Estimated Expiration: ⤷ Sign Up

Russian Federation

Patent: 03297
Patent: КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ЛЕЧЕНИЯ БЕССОННИЦЫ (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Estimated Expiration: ⤷ Sign Up

Patent: 17112308
Patent: КОМПОЗИЦИИ И СПОСОБЫ ДЛЯ ЛЕЧЕНИЯ БЕССОННИЦЫ
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 202007759R
Patent: COMPOSITIONS AND METHODS FOR TREATING INSOMNIA
Estimated Expiration: ⤷ Sign Up

Patent: 201703064W
Patent: COMPOSITIONS AND METHODS FOR TREATING INSOMNIA
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 2444608
Estimated Expiration: ⤷ Sign Up

Patent: 170068478
Patent: 불면증을 치료하기 위한 조성물 및 방법 (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 43952
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Spain	2843952		⤷ Sign Up
European Patent Office	3209298	COMPOSITIONS ET MÉTHODES POUR TRAITER L'INSOMNIE (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA)	⤷ Sign Up
Singapore	10202007759R	COMPOSITIONS AND METHODS FOR TREATING INSOMNIA	⤷ Sign Up
Mexico	2017004950	COMPOSICIONES Y METODOS PARA TRATAR EL INSOMNIO. (COMPOSITIONS AND METHODS FOR TREATING INSOMNIA.)	⤷ Sign Up
Singapore	188585	CYCLOPROPANE COMPOUND	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration