FDA Orange Book
Generic for Alimta
Alimta contains pemetrexed. 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 Alimta is pemetrexed. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Alimta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 100MG BASE/VIAL | Marketed (Rx) | AP | 13 | AP |
| powder, intravenous | EQ 500MG BASE/VIAL | Marketed (Rx) | AP | 12 | AP |
NDA 021462, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic pemetrexed
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 203485 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| APOTEX INC | 203774 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| DR REDDYS LABORATORIES LTD | 202596 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 214632 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| FRESENIUS KABI USA LLC | 090384 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 208696 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| NANG KUANG PHARMACEUTICAL CO LTD | 207352 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 204890 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| SOMERSET THERAPEUTICS LLC | 211899 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 214073 | AP (A-rated, therapeutically equivalent) | May 25, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 215479 | AP (A-rated, therapeutically equivalent) | December 13, 2022 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
| PRINSTON PHARMACEUTICAL INC | 216582 | AP (A-rated, therapeutically equivalent) | December 11, 2023 | EQ 100MG BASE/VIAL |
| HETERO LABS LTD UNIT VI | 215460 | AP (A-rated, therapeutically equivalent) | June 14, 2024 | EQ 100MG BASE/VIAL, EQ 500MG BASE/VIAL |
Alimta NDC codes
Questions
Is there a generic for Alimta?
Yes. The generic name for Alimta is pemetrexed. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Alimta?
The active ingredient in Alimta is pemetrexed, 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.