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Lenvima

Lenvatinib · Kit

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Lenvima
Generic name
Lenvatinib
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
Eisai Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
3
Packages
3
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
206947
Application type
NDA · New Drug Application
Approval date
February 13, 2015
Sponsor
EISAI INC
Products on application
2
Submissions recorded
24
Products approved under application 206947.
Product Trade name Form Strength Ingredient Status TE Flags
206947-001 LENVIMA CAPSULE LENVATINIB MESYLATE Prescription — RLD
206947-002 LENVIMA CAPSULE LENVATINIB MESYLATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
7253286 October 24, 2025 001 Yes March 10, 2015
7253286 October 24, 2025 002 Yes March 10, 2015
7253286*PED April 24, 2026 001 No —
7253286*PED April 24, 2026 002 No —
7612208 September 19, 2026 001 Yes March 10, 2015
7612208 September 19, 2026 002 Yes March 10, 2015
7612208*PED March 19, 2027 001 No —
7612208*PED March 19, 2027 002 No —
9006256 July 27, 2027 001 No U-1695 May 12, 2015
9006256 July 27, 2027 002 No U-1695 May 12, 2015
9006256*PED January 27, 2028 001 No —
9006256*PED January 27, 2028 002 No —
12508313 October 4, 2030 001 No December 30, 2025
12508313 October 4, 2030 002 No December 30, 2025
12508313*PED April 4, 2031 001 No —
12508313*PED April 4, 2031 002 No —
11186547 August 26, 2035 001 Yes December 17, 2021
10407393 August 26, 2035 001 Yes October 4, 2019
10259791 August 26, 2035 001 Yes May 13, 2019
11186547 August 26, 2035 002 Yes December 17, 2021
10407393 August 26, 2035 002 Yes October 4, 2019
10259791 August 26, 2035 002 Yes May 13, 2019
11090386 February 23, 2036 001 No U-3519 February 10, 2023
11090386 February 23, 2036 002 No U-3519 February 10, 2023
11186547*PED February 26, 2036 001 No —
10407393*PED February 26, 2036 001 No —
10259791*PED February 26, 2036 001 No —
11186547*PED February 26, 2036 002 No —
10407393*PED February 26, 2036 002 No —
10259791*PED February 26, 2036 002 No —
12083112 March 3, 2036 001 No U-3996 October 3, 2024
12083112 March 3, 2036 001 No U-3997 October 3, 2024
12083112 March 3, 2036 002 No U-3996 October 3, 2024
12083112 March 3, 2036 002 No U-3997 October 3, 2024
11090386*PED August 23, 2036 001 No —
11090386*PED August 23, 2036 002 No —
12083112*PED September 3, 2036 001 No —
12083112*PED September 3, 2036 002 No —
12226409 May 15, 2038 001 No U-4146 March 7, 2025
12226409 May 15, 2038 002 No U-4146 March 7, 2025
12226409*PED November 15, 2038 001 No —
12226409*PED November 15, 2038 002 No —
Regulatory exclusivity periods.
Code Expires Product
ODE-196 August 15, 2025 001
ODE-196 August 15, 2025 002
PED February 15, 2026 001
PED February 15, 2026 002
M-14 April 3, 2027 001
M-14 April 3, 2027 002
PED October 3, 2027 001
PED October 3, 2027 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 206947.
Type No. Action Status Date Review
Supplement 33 Efficacy Approved January 29, 2025 Priority
Supplement 32 Labeling Approved November 20, 2024 Standard
Supplement 31 Efficacy Approved June 7, 2024 Standard
Supplement 30 Efficacy Approved April 3, 2024 Priority
Supplement 28 Efficacy Approved October 23, 2023 Standard
Supplement 24 Labeling Approved November 10, 2022 Standard
Supplement 25 Labeling Approved August 5, 2022 Standard
Supplement 21 Efficacy Approved December 19, 2021 Standard
Supplement 19 Efficacy Approved August 10, 2021 Priority
Supplement 20 Efficacy Approved July 21, 2021 Priority
Supplement 18 Labeling Approved December 18, 2020 Standard
Supplement 16 Labeling Approved November 10, 2020 Standard
Supplement 17 Labeling Approved September 14, 2020 Standard
Supplement 13 Labeling Approved April 23, 2020 Standard
Supplement 12 Labeling Approved February 20, 2020 Standard
Supplement 11 Efficacy Approved September 17, 2019 Priority
Supplement 9 Labeling Approved December 7, 2018 Standard
Supplement 7 Efficacy Approved August 15, 2018 Standard
Supplement 8 Labeling Approved June 6, 2018 Standard
Supplement 5 Labeling Approved July 31, 2017 Standard
Supplement 3 Efficacy Approved May 13, 2016 Priority
Supplement 4 Labeling Approved April 22, 2016 Standard
Supplement 1 Manufacturing (CMC) Approved October 16, 2015 Priority
Original application 1 Type 1 - New Molecular Entity Approved February 13, 2015 Priority

Review documents

  • 0 · Supplement · February 7, 2025
  • 0 · Supplement · February 5, 2025
  • 0 · Supplement · November 21, 2024
  • 0 · Supplement · November 21, 2024
  • 0 · Supplement · July 2, 2024
  • 0 · Supplement · June 10, 2024
  • 0 · Supplement · April 4, 2024
  • 0 · Supplement · April 3, 2024
  • 0 · Supplement · October 24, 2023
  • 0 · Supplement · October 24, 2023
  • 0 · Supplement · May 10, 2023
  • 0 · Supplement · November 14, 2022
  • 0 · Supplement · November 13, 2022
  • 0 · Supplement · August 8, 2022
  • 0 · Supplement · August 8, 2022
  • 0 · Supplement · May 16, 2022
  • 0 · Supplement · December 21, 2021
  • 0 · Supplement · August 11, 2021
  • 0 · Supplement · August 11, 2021
  • 0 · Supplement · July 22, 2021
  • 0 · Supplement · July 22, 2021
  • 0 · Supplement · December 22, 2020
  • 0 · Supplement · December 22, 2020
  • 0 · Supplement · November 12, 2020
  • 0 · Supplement · November 12, 2020
  • 0 · Supplement · September 21, 2020
  • 0 · Supplement · September 16, 2020
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · May 1, 2020
  • 0 · Supplement · February 28, 2020

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
62856-714-30 62856-714 Eisai Inc. 6 BLISTER PACK in 1 BOX (62856-714-30) / 1 KIT in 1 BLISTER PACK (62856-714-05) February 13, 2015
62856-718-30 62856-718 Eisai Inc. 6 BLISTER PACK in 1 BOX (62856-718-30) / 1 KIT in 1 BLISTER PACK (62856-718-05) May 13, 2016
62856-724-30 62856-724 Eisai Inc. 6 BLISTER PACK in 1 BOX (62856-724-30) / 1 KIT in 1 BLISTER PACK (62856-724-05) February 13, 2015
62856-714 62856-714 Eisai Inc. — February 13, 2015
62856-718 62856-718 Eisai Inc. — May 13, 2016
62856-724 62856-724 Eisai Inc. — February 13, 2015

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.