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-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 |


DrugPatentWatch® Estimated Generic Entry Opportunity 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
Sponsor | Phase |
---|---|
University of California, San Francisco | Phase 4 |
Eisai Inc. | Phase 1 |
Virginia Commonwealth University | Phase 1/Phase 2 |
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
US Patents and Regulatory Information for DAYVIGO
DAYVIGO is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of DAYVIGO is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
Cyclopropane compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-002 | Apr 7, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-001 | Apr 7, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>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: See Plans and Pricing
Brazil
Patent: 2017007063
Estimated Expiration: See Plans and Pricing
Canada
Patent: 64504
Estimated Expiration: See Plans and Pricing
China
Patent: 7810006
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 09298
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1759
Estimated Expiration: See Plans and Pricing
Japan
Patent: 59681
Estimated Expiration: See Plans and Pricing
Patent: 17531683
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 17004950
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 03297
Estimated Expiration: See Plans and Pricing
Patent: 17112308
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 202007759R
Estimated Expiration: See Plans and Pricing
Patent: 201703064W
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 170068478
Estimated Expiration: See Plans and Pricing
Spain
Patent: 43952
Estimated Expiration: See Plans and Pricing
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 | See Plans and Pricing | |
Morocco | 34609 | COMPOSÉ DE CYCLOPROPANE | See Plans and Pricing |
Singapore | 10202007759R | COMPOSITIONS AND METHODS FOR TREATING INSOMNIA | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |