➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Dow
Express Scripts
Moodys
Harvard Business School
Baxter

Last Updated: January 22, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 212028

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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
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:
Patent:  Start TrialPatent Expiration:Oct 21, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Sep 20, 2031Product Flag?YSubstance Flag?YDelist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
Mallinckrodt
Express Scripts
Colorcon
Johnson and Johnson

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.