FDA Orange Book
Generic for Abraxane
Abraxane contains paclitaxel. 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 Abraxane is paclitaxel. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Abraxane and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Abraxane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 100MG/VIAL | Marketed (Rx) | AB | 4 | AB |
NDA 021660, held by BRISTOL-MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic paclitaxel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 212700 | AB (A-rated, therapeutically equivalent) | October 8, 2024 | 100MG/VIAL |
| CIPLA LTD | 209657 | AB (A-rated, therapeutically equivalent) | April 10, 2025 | 100MG/VIAL |
| HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | 216355 | AB (A-rated, therapeutically equivalent) | May 15, 2025 | 100MG/VIAL |
| MYLAN PHARMACEUTICALS INC | 217877 | AB (A-rated, therapeutically equivalent) | August 19, 2025 | 100MG/VIAL |
Abraxane patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8268348 | February 21, 2026 | Method of use | U-1290 | 021660 |
| 9101543 | February 21, 2026 | Method of use | U-1434 | 021660 |
| 7758891 | February 21, 2026 | Method of use | U-1434 | 021660 |
| 8034375 | August 13, 2026 | Method of use | U-1290 | 021660 |
| 8268348*PED | August 21, 2026 | Method of use | None | 021660 |
| 7758891*PED | August 21, 2026 | Method of use | None | 021660 |
| 9101543*PED | August 21, 2026 | Method of use | None | 021660 |
| 8034375*PED | February 13, 2027 | Method of use | None | 021660 |
| 9393318 | March 4, 2032 | Method of use | U-1290 | 021660 |
| 9597409 | March 4, 2032 | Method of use | U-1290 | 021660 |
| 9393318*PED | September 4, 2032 | Method of use | None | 021660 |
| 9597409*PED | September 4, 2032 | Method of use | None | 021660 |
| 9511046 | January 12, 2034 | Method of use | U-1434 | 021660 |
| 9511046*PED | July 12, 2034 | Method of use | None | 021660 |
Abraxane NDC codes
Questions
Is there a generic for Abraxane?
Yes. The generic name for Abraxane is paclitaxel. 4 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 Abraxane?
The active ingredient in Abraxane is paclitaxel, per the FDA Orange Book.
When does the Abraxane patent expire?
The last patent listed for Abraxane in the Orange Book expires July 12, 2034. A listed patent expiry date is not a generic launch date.
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.