FDA Orange Book
Is there a generic for Lenvima?
Lenvima contains lenvatinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lenvima (lenvatinib). The Orange Book shows its last listed patent expires November 15, 2038 and its last listed exclusivity ends October 3, 2027.
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Lenvima products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
NDA 206947, held by EISAI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lenvima patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7253286 | October 24, 2025 | Drug substance, Drug product | None | 206947 |
| 7253286*PED | April 24, 2026 | Method of use | None | 206947 |
| 7612208 | September 19, 2026 | Drug substance, Drug product | None | 206947 |
| 7612208*PED | March 19, 2027 | Method of use | None | 206947 |
| 9006256 | July 27, 2027 | Method of use | U-1695 | 206947 |
| 9006256*PED | January 27, 2028 | Method of use | None | 206947 |
| 12508313 | October 4, 2030 | Drug product | None | 206947 |
| 12508313*PED | April 4, 2031 | Method of use | None | 206947 |
| 11186547 | August 26, 2035 | Drug substance | None | 206947 |
| 10407393 | August 26, 2035 | Drug substance | None | 206947 |
| 10259791 | August 26, 2035 | Drug substance | None | 206947 |
| 11090386 | February 23, 2036 | Method of use | U-3519 | 206947 |
| 11186547*PED | February 26, 2036 | Method of use | None | 206947 |
| 10407393*PED | February 26, 2036 | Method of use | None | 206947 |
| 10259791*PED | February 26, 2036 | Method of use | None | 206947 |
| 12083112 | March 3, 2036 | Method of use | U-3996 | 206947 |
| 12083112 | March 3, 2036 | Method of use | U-3997 | 206947 |
| 11090386*PED | August 23, 2036 | Method of use | None | 206947 |
| 12083112*PED | September 3, 2036 | Method of use | None | 206947 |
| 12226409 | May 15, 2038 | Method of use | U-4146 | 206947 |
| 12226409*PED | November 15, 2038 | Method of use | None | 206947 |
Lenvima exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-196 | Orphan drug exclusivity | August 15, 2025 | 206947 |
| PED | Pediatric exclusivity | February 15, 2026 | 206947 |
| M-14 | Miscellaneous | April 3, 2027 | 206947 |
| PED | Pediatric exclusivity | October 3, 2027 | 206947 |
Lenvima NDC codes
Questions
Is there a generic for Lenvima?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lenvima (lenvatinib). The Orange Book shows its last listed patent expires November 15, 2038 and its last listed exclusivity ends October 3, 2027.
What is the generic name for Lenvima?
The active ingredient in Lenvima is lenvatinib, per the FDA Orange Book.
When does the Lenvima patent expire?
The last patent listed for Lenvima in the Orange Book expires November 15, 2038. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.