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Last Updated: March 1, 2024

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 two 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 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

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Summary for DAYVIGO
International Patents:53
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 42
Clinical Trials: 7
Patent Applications: 15
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
Drug Prices for DAYVIGO

See drug prices for DAYVIGO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAYVIGO
Generic Entry Date for DAYVIGO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Brendan LuceyPhase 2
Eisai Inc.Phase 2
Eisai Co., Ltd.Phase 2

See all DAYVIGO clinical trials

Pharmacology for DAYVIGO

US Patents and Regulatory Information for DAYVIGO

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

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE

Cyclopropane compound
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Eisai Inc DAYVIGO lemborexant TABLET;ORAL 212028-002 Apr 7, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc DAYVIGO lemborexant TABLET;ORAL 212028-001 Apr 7, 2020 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2017007063
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 64504
Estimated Expiration: ⤷  Try a Trial

China

Patent: 7810006
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 09298
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1759
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 59681
Estimated Expiration: ⤷  Try a Trial

Patent: 17531683
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 17004950
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 03297
Estimated Expiration: ⤷  Try a Trial

Patent: 17112308
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 202007759R
Estimated Expiration: ⤷  Try a Trial

Patent: 201703064W
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2444608
Estimated Expiration: ⤷  Try a Trial

Patent: 170068478
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 43952
Estimated Expiration: ⤷  Try a Trial

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
Chile 2013000784 Compuestos derivados de (n,2-difenil)- o (2-fenil-n-piridin)- 2-[(pirimidin-5iloxi)metil]ciclopopanocarboxamida, antagonista del receptor de orexina; composicion farmaceutica; que los comprende; y su uso en transtorno del sueño tal como insomnio. (pct fase nacional) ⤷  Try a Trial
Taiwan 201305129 Cyclopropane compound ⤷  Try a Trial
Spain 2540851 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.