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DAYVIGO Drug 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-one 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: | 51 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 3 |
| Patent Applications: | 32 |
| 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 |
|---|---|
| Eisai Inc. | Phase 1 |
| National Institute on Drug Abuse (NIDA) | Phase 1/Phase 2 |
| Virginia Commonwealth University | Phase 1/Phase 2 |
US Patents and Regulatory Information for 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 | Get Started Free | Get Started Free | Y | Y | Get Started Free | ||
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-002 | Apr 7, 2020 | RX | Yes | Yes | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-001 | Apr 7, 2020 | RX | Yes | No | Get Started Free | Get Started Free | Y | Get Started Free | |||
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-001 | Apr 7, 2020 | RX | Yes | No | Get Started Free | Get Started Free | Get Started Free | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Jordan | 2990 | Get Started Free |
| European Patent Office | 3209298 | Get Started Free |
| Singapore | 10202007759R | Get Started Free |
| Portugal | 2626350 | Get Started Free |
| >Country | >Patent Number | >Estimated Expiration |
