FDA Orange Book
Generic for Sutent
Sutent contains sunitinib malate. 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
Yes. The generic name for Sutent is sunitinib malate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sutent products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 12.5MG BASE | Marketed (Rx) | AB | 8 | AB |
| capsule, oral | EQ 25MG BASE | Marketed (Rx) | AB | 8 | AB |
| capsule, oral | EQ 37.5MG BASE | Marketed (Rx) | AB | 8 | AB |
| capsule, oral | EQ 50MG BASE | Marketed (Rx) | AB | 8 | AB |
NDA 021938, held by CP PHARMACEUTICALS INTERNATIONAL CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sunitinib malate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 213914 | AB (A-rated, therapeutically equivalent) | August 16, 2021 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| TEVA PHARMACEUTICALS USA | 213803 | AB (A-rated, therapeutically equivalent) | November 30, 2021 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| MYLAN PHARMACEUTICALS INC | 201275 | AB (A-rated, therapeutically equivalent) | December 6, 2021 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| DR REDDYS LABORATORIES LTD | 215843 | AB (A-rated, therapeutically equivalent) | April 11, 2022 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO LTD | 218012 | AB (A-rated, therapeutically equivalent) | August 21, 2023 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| NATCO PHARMA LTD | 218024 | AB (A-rated, therapeutically equivalent) | October 24, 2023 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 218615 | AB (A-rated, therapeutically equivalent) | March 14, 2024 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
| MSN LABORATORIES PRIVATE LTD | 214824 | AB (A-rated, therapeutically equivalent) | February 14, 2025 | EQ 12.5MG BASE, EQ 25MG BASE, EQ 37.5MG BASE, EQ 50MG BASE |
Sutent NDC codes
Questions
Is there a generic for Sutent?
Yes. The generic name for Sutent is sunitinib malate. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sutent?
The active ingredient in Sutent is sunitinib malate, per the FDA Orange Book.
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.