DAYVIGO Drug Patent Profile
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Which patents cover Dayvigo, and when can generic versions of Dayvigo launch?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAYVIGO
*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 |
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
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
| 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
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2017007063
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 64504
Estimated Expiration: ⤷ Sign Up
China
Patent: 7810006
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 09298
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1759
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 59681
Estimated Expiration: ⤷ Sign Up
Patent: 17531683
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 17004950
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 03297
Estimated Expiration: ⤷ Sign Up
Patent: 17112308
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202007759R
Estimated Expiration: ⤷ Sign Up
Patent: 201703064W
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2444608
Estimated Expiration: ⤷ Sign Up
Patent: 170068478
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.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2016063995 | ⤷ Sign Up | |
| Peru | 20131162 | COMPUESTOS DE CICLOPROPANO COMO ANTAGONISTAS DEL RECEPTOR DE OREXINA | ⤷ Sign Up |
| Singapore | 11201703064W | COMPOSITIONS AND METHODS FOR TREATING INSOMNIA | ⤷ Sign Up |
| South Korea | 102444608 | ⤷ Sign Up | |
| Croatia | P20150657 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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