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Last Updated: January 21, 2022

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212028


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NDA 212028 describes DAYVIGO, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the DAYVIGO profile page.

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
DrugPatentWatch® Estimated 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:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 7, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 7, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Try it FreePatent Expiration:Oct 21, 2035Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
Patent:⤷  Try it FreePatent Expiration:Sep 20, 2031Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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