FDA Orange Book
Generic for Doxil (liposomal)
Doxil (liposomal) contains doxorubicin. 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 Doxil (liposomal) is doxorubicin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Doxil (liposomal) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, liposomal, injection | 20MG/10ML (2MG/ML) | Marketed (Rx) | AB | 8 | AB |
| injectable, liposomal, injection | 50MG/25ML (2MG/ML) | Marketed (Rx) | AB | 8 | AB |
NDA 050718, held by BAXTER HEALTHCARE CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxorubicin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 203263 | AB (A-rated, therapeutically equivalent) | February 4, 2013 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| DR REDDYS LABORATORIES LTD | 208657 | AB (A-rated, therapeutically equivalent) | May 15, 2017 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| ZYDUS LIFESCIENCES GLOBAL FZE | 212299 | AB (A-rated, therapeutically equivalent) | September 10, 2020 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| AYANA PHARMA LTD | 207228 | AB (A-rated, therapeutically equivalent) | October 12, 2021 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| BAXTER HEALTHCARE CORP | 212219 | AB (A-rated, therapeutically equivalent) | October 19, 2022 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| LUPIN INC | 215178 | AB (A-rated, therapeutically equivalent) | July 16, 2024 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| ALEMBIC PHARMACEUTICALS LTD | 219199 | AB (A-rated, therapeutically equivalent) | June 27, 2025 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
| QILU PHARMACEUTICAL HAINAN CO LTD | 219881 | AB (A-rated, therapeutically equivalent) | February 3, 2026 | 20MG/10ML (2MG/ML), 50MG/25ML (2MG/ML) |
Doxil (liposomal) NDC codes
Questions
Is there a generic for Doxil (liposomal)?
Yes. The generic name for Doxil (liposomal) is doxorubicin. 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 Doxil (liposomal)?
The active ingredient in Doxil (liposomal) is doxorubicin, 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.