FDA Orange Book
Generic for Gleevec
Gleevec contains imatinib. 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 Gleevec is imatinib. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Gleevec products the Orange Book lists.
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Gleevec products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 50MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 100MG BASE | Marketed (Rx) | AB | 12 | AB |
| tablet, oral | EQ 400MG BASE | Marketed (Rx) | AB | 12 | AB |
NDA 021335, 021588, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic imatinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 204285 | AB (A-rated, therapeutically equivalent) | August 4, 2016 | EQ 100MG BASE, EQ 400MG BASE |
| APOTEX INC | 079179 | AB (A-rated, therapeutically equivalent) | August 5, 2016 | EQ 100MG BASE, EQ 400MG BASE |
| MYLAN PHARMACEUTICALS INC | 204644 | AB (A-rated, therapeutically equivalent) | June 21, 2017 | EQ 100MG BASE, EQ 400MG BASE |
| DR REDDYS LABORATORIES LTD | 206547 | AB (A-rated, therapeutically equivalent) | August 13, 2018 | EQ 100MG BASE, EQ 400MG BASE |
| CHARTWELL RX SCIENCES LLC | 208429 | AB (A-rated, therapeutically equivalent) | January 17, 2019 | EQ 100MG BASE, EQ 400MG BASE |
| SHILPA MEDICARE LTD | 208302 | AB (A-rated, therapeutically equivalent) | January 17, 2019 | EQ 100MG BASE, EQ 400MG BASE |
| NATCO PHARMA LTD | 207818 | AB (A-rated, therapeutically equivalent) | March 1, 2019 | EQ 100MG BASE, EQ 400MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 210658 | AB (A-rated, therapeutically equivalent) | April 8, 2020 | EQ 100MG BASE, EQ 400MG BASE |
| EUGIA PHARMA SPECIALITIES LTD | 212773 | AB (A-rated, therapeutically equivalent) | July 23, 2020 | EQ 100MG BASE, EQ 400MG BASE |
| QILU PHARMACEUTICAL HAINAN CO LTD | 212135 | AB (A-rated, therapeutically equivalent) | June 21, 2022 | EQ 100MG BASE, EQ 400MG BASE |
| HETERO LABS LTD UNIT V | 212975 | AB (A-rated, therapeutically equivalent) | April 14, 2025 | EQ 100MG BASE, EQ 400MG BASE |
| CSPC OUYI PHARMACEUTICAL CO LTD | 212193 | AB (A-rated, therapeutically equivalent) | April 21, 2025 | EQ 100MG BASE, EQ 400MG BASE |
Gleevec NDC codes
Questions
Is there a generic for Gleevec?
Yes. The generic name for Gleevec is imatinib. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 4 Gleevec products the Orange Book lists.
What is the generic name for Gleevec?
The active ingredient in Gleevec is imatinib, 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.