DAYVIGO Drug Patent Profile

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 two patents protecting this drug.

This drug has fifty-two 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 will be eligible for patent challenges on April 7, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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

Summary for DAYVIGO

International Patents:	52
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	4
Patent Applications:	11
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 Generic Entry Opportunity Date for DAYVIGO

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
University of California, San Francisco	Phase 4
Eisai Inc.	Phase 1
Virginia Commonwealth University	Phase 1/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

Anatomical Therapeutic Chemical (ATC) Classes for DAYVIGO

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

US Patents and Regulatory Information for DAYVIGO

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

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

FDA Regulatory Exclusivity protecting DAYVIGO

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			Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes			Y	Y
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No			Y	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
Poland	2626350
Morocco	34609	COMPOSÉ DE CYCLOPROPANE
Singapore	10202007759R	COMPOSITIONS AND METHODS FOR TREATING INSOMNIA