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Details for New Drug Application (NDA): 212028
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The generic ingredient in DAYVIGO is lemborexant. One supplier is listed for this compound. Additional details are available on the lemborexant profile page.
Summary for 212028
Tradename: | DAYVIGO |
Applicant: | Eisai Inc |
Ingredient: | lemborexant |
Patents: | 2 |
Generic Entry Opportunity Date for 212028
Generic Entry Date for 212028*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 212028
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-405 | 62856-405-10 | 1 BLISTER PACK in 1 CARTON (62856-405-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK |
DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-405 | 62856-405-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Apr 7, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Apr 7, 2025 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Oct 21, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Sep 20, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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