FDA Orange Book
Generic for Tarceva
Tarceva contains erlotinib. 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 Tarceva is erlotinib. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Tarceva products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 100MG BASE | Discontinued | None | 7 | AB |
| tablet, oral | EQ 150MG BASE | Discontinued | None | 8 | AB |
| tablet, oral | EQ 25MG BASE | Discontinued | None | 8 | AB |
NDA 021743, held by OSI PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic erlotinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 091002 | AB (A-rated, therapeutically equivalent) | June 11, 2014 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| TEVA PHARMACEUTICALS USA INC | 091059 | AB (A-rated, therapeutically equivalent) | August 28, 2015 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| ADAPTIS PHARMA PRIVATE LTD | 211960 | AB (A-rated, therapeutically equivalent) | November 5, 2019 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 213065 | AB (A-rated, therapeutically equivalent) | April 16, 2020 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| MSN LABORATORIES PRIVATE LTD | 214366 | AB (A-rated, therapeutically equivalent) | May 10, 2021 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| ALEMBIC PHARMACEUTICALS LTD | 214719 | AB (A-rated, therapeutically equivalent) | July 8, 2021 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| HETERO LABS LTD UNIT V | 209267 | AB (A-rated, therapeutically equivalent) | May 24, 2024 | EQ 100MG BASE, EQ 150MG BASE, EQ 25MG BASE |
| CHARTWELL RX SCIENCES LLC | 203843 | AB (A-rated, therapeutically equivalent) | September 13, 2024 | EQ 150MG BASE, EQ 25MG BASE |
Questions
Is there a generic for Tarceva?
Yes. The generic name for Tarceva is erlotinib. 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 Tarceva?
The active ingredient in Tarceva is erlotinib, 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.