FDA Orange Book
Generic for Lovenox
Lovenox contains enoxaparin. 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 Lovenox is enoxaparin. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Lovenox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous, subcutaneous | 300MG/3ML (100MG/ML) | Marketed (Rx) | AB | 3 | AB |
NDA 020164, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic enoxaparin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 078660 | AB (A-rated, therapeutically equivalent) | November 28, 2011 | 300MG/3ML (100MG/ML) |
| AMPHASTAR PHARMACEUTICALS INC | 208600 | AB (A-rated, therapeutically equivalent) | March 14, 2019 | 300MG/3ML (100MG/ML) |
| EMERGE BIOSCIENCE PTE LTD | 214856 | AB (A-rated, therapeutically equivalent) | June 14, 2022 | 300MG/3ML (100MG/ML) |
Lovenox NDC codes
Questions
Is there a generic for Lovenox?
Yes. The generic name for Lovenox is enoxaparin. 3 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 Lovenox?
The active ingredient in Lovenox is enoxaparin, 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.