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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 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.
US ANDA Litigation and 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: | 50 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 18 |
| Patent Applications: | 7 |
| DailyMed Link: | DAYVIGO at DailyMed |
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.
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-002 | Apr 7, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028-001 | Apr 7, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Serbia | 54101 | Start Trial |
| European Patent Office | 3209298 | Start Trial |
| Peru | 20131162 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
