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 four patents protecting this drug. Additional details are available on the DAYVIGO profile page.
The generic ingredient in DAYVIGO is lemborexant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lemborexant profile page.
The generic ingredient in DAYVIGO is lemborexant. There is one drug master file entry for this compound. 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: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
Pharmacology for NDA: 212028
| Mechanism of Action | Cytochrome P450 2B6 Inducers Orexin Receptor Antagonists |
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 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE LABELING TO INCLUDE RESULTS FROM CLINICAL STUDY E2006-A001-113 | ||||||||
| Patent: | 10,188,652 | Patent Expiration: | Oct 21, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH INSOMNIA, CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE | ||||||||
| Patent: | 10,702,529 | Patent Expiration: | Oct 21, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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