Details for New Drug Application (NDA): 206947
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NDA 206947 describes LENVIMA, which is a drug marketed by Eisai Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LENVIMA profile page.
The generic ingredient in LENVIMA is lenvatinib mesylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenvatinib mesylate profile page.
The generic ingredient in LENVIMA is lenvatinib mesylate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lenvatinib mesylate profile page.
Summary for 206947
| Tradename: | LENVIMA |
| Applicant: | Eisai Inc |
| Ingredient: | lenvatinib mesylate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206947
Generic Entry Date for 206947*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 206947
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Suppliers and Packaging for NDA: 206947
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-704 | 62856-704-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-704-30) / 5 CAPSULE in 1 BLISTER PACK (62856-704-05) |
| LENVIMA | lenvatinib mesylate | CAPSULE;ORAL | 206947 | NDA | Eisai Inc. | 62856-708 | 62856-708-30 | 6 BLISTER PACK in 1 BOX, UNIT-DOSE (62856-708-30) / 10 CAPSULE in 1 BLISTER PACK (62856-708-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Feb 13, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 3, 2027 | ||||||||
| Regulatory Exclusivity Use: | ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION | ||||||||
| Regulatory Exclusivity Expiration: | Aug 15, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) | ||||||||
| Regulatory Exclusivity Expiration: | Aug 10, 2024 | ||||||||
| Regulatory Exclusivity Use: | LENVATINIB IN COMBINATION WITH PEMBROLIZUMAB, IS INDICATED FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA (RCC) | ||||||||
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