Orange Book product · Brand (NDA)
LENVIMA
LENVATINIB MESYLATE
At a glance
Feb 13, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
21
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 13, 2015
11 yr 6 mo ago
Exclusivity ends · ODE-196
Orphan-drug exclusivity (7 years)
Aug 15, 2025
10 mo ago
Patent 7253286 expires
Listed drug substance patent expiration.
Oct 24, 2025
8 mo ago
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Feb 15, 2026
4 mo ago
Patent 7253286*PED expires
Listed listed patent expiration.
Apr 24, 2026
2 mo ago
Today
Patent 7612208 expires
Listed drug substance patent expiration.
Sep 19, 2026
in 3 mo
Patent 7612208*PED expires
Listed listed patent expiration.
Mar 19, 2027
in 9 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
Apr 03, 2027
in 10 mo
Patent 9006256 expires
Listed method-of-use patent (U-1695) expiration.
Jul 27, 2027
in 1 yr 1 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Oct 03, 2027
in 1 yr 4 mo
Patent 9006256*PED expires
Listed listed patent expiration.
Jan 27, 2028
in 1 yr 8 mo
Patent 12508313 expires
Listed drug product patent expiration.
Oct 04, 2030
in 4 yr 4 mo
Patent 12508313*PED expires
Listed listed patent expiration.
Apr 04, 2031
in 4 yr 10 mo
Patent 10259791 expires
Listed drug substance patent expiration.
Aug 26, 2035
in 9 yr 4 mo
Patent 10407393 expires
Listed drug substance patent expiration.
Aug 26, 2035
in 9 yr 4 mo
Patent 11186547 expires
Listed drug substance patent expiration.
Aug 26, 2035
in 9 yr 4 mo
Patent 11090386 expires
Listed method-of-use patent (U-3519) expiration.
Feb 23, 2036
in 9 yr 10 mo
Patent 10259791*PED expires
Listed listed patent expiration.
Feb 26, 2036
in 9 yr 10 mo
Patent 10407393*PED expires
Listed listed patent expiration.
Feb 26, 2036
in 9 yr 10 mo
Patent 11186547*PED expires
Listed listed patent expiration.
Feb 26, 2036
in 9 yr 10 mo
Patent 12083112 expires
Listed method-of-use patent (U-3996) expiration.
Mar 03, 2036
in 9 yr 10 mo
Patent 12083112 expires
Listed method-of-use patent (U-3997) expiration.
Mar 03, 2036
in 9 yr 10 mo
Patent 11090386*PED expires
Listed listed patent expiration.
Aug 23, 2036
in 10 yr 4 mo
Patent 12083112*PED expires
Listed listed patent expiration.
Sep 03, 2036
in 10 yr 4 mo
Patent 12226409 expires
Listed method-of-use patent (U-4146) expiration.
May 15, 2038
in 12 yr 1 mo
Patent 12226409*PED expires
Listed listed patent expiration.
Nov 15, 2038
in 12 yr 7 mo
Pharmaceutical detail
Active ingredient
LENVATINIB MESYLATE
Strength
EQ 4MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 206947
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- ODE-196Orphan-drug exclusivity (7 years)
Aug 15, 2025
10 mo ago
- PEDPediatric exclusivity (adds 6 months)
Feb 15, 2026
4 mo ago
- M-14New use / labeling-change exclusivity (3 years)
Apr 03, 2027
in 10 mo
- PEDPediatric exclusivity (adds 6 months)
Oct 03, 2027
in 1 yr 4 mo
Listed patents (21)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7253286 | Oct 24, 2025 | 8 mo ago | SubstanceProduct |
| 7253286*PED | Apr 24, 2026 | 2 mo ago | |
| 7612208 | Sep 19, 2026 | in 3 mo | SubstanceProduct |
| 7612208*PED | Mar 19, 2027 | in 9 mo | |
| 9006256 | Jul 27, 2027 | in 1 yr 1 mo | U-1695 |
| 9006256*PED | Jan 27, 2028 | in 1 yr 8 mo | |
| 12508313 | Oct 04, 2030 | in 4 yr 4 mo | Product |
| 12508313*PED | Apr 04, 2031 | in 4 yr 10 mo | |
| 10259791 | Aug 26, 2035 | in 9 yr 4 mo | Substance |
| 10407393 | Aug 26, 2035 | in 9 yr 4 mo | Substance |
| 11186547 | Aug 26, 2035 | in 9 yr 4 mo | Substance |
| 11090386 | Feb 23, 2036 | in 9 yr 10 mo | U-3519 |
| 10259791*PED | Feb 26, 2036 | in 9 yr 10 mo | |
| 10407393*PED | Feb 26, 2036 | in 9 yr 10 mo | |
| 11186547*PED | Feb 26, 2036 | in 9 yr 10 mo | |
| 12083112 | Mar 03, 2036 | in 9 yr 10 mo | U-3996 |
| 12083112 | Mar 03, 2036 | in 9 yr 10 mo | U-3997 |
| 11090386*PED | Aug 23, 2036 | in 10 yr 4 mo | |
| 12083112*PED | Sep 03, 2036 | in 10 yr 4 mo | |
| 12226409 | May 15, 2038 | in 12 yr 1 mo | U-4146 |
| 12226409*PED | Nov 15, 2038 | in 12 yr 7 mo |

