FDA Orange Book
Generic for Angiomax
Angiomax contains bivalirudin. 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 Angiomax is bivalirudin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Angiomax products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous | 250MG/VIAL | Marketed (Rx) | AP | 7 | AP |
NDA 020873, held by SANDOZ INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bivalirudin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 090189 | AP (A-rated, therapeutically equivalent) | October 28, 2016 | 250MG/VIAL |
| DR REDDYS LABORATORIES LTD | 201577 | AP (A-rated, therapeutically equivalent) | May 26, 2017 | 250MG/VIAL |
| ACCORD HEALTHCARE INC | 206551 | AP (A-rated, therapeutically equivalent) | November 22, 2017 | 250MG/VIAL |
| MYLAN INSTITUTIONAL LLC | 202471 | AP (A-rated, therapeutically equivalent) | June 1, 2018 | 250MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 091602 | AP (A-rated, therapeutically equivalent) | July 16, 2018 | 250MG/VIAL |
| HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | 210031 | AP (A-rated, therapeutically equivalent) | October 23, 2019 | 250MG/VIAL |
| HAINAN POLY PHARM CO LTD | 213078 | AP (A-rated, therapeutically equivalent) | May 28, 2021 | 250MG/VIAL |
Angiomax patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7582727 | July 27, 2028 | Drug product | None | 020873 |
| 7598343 | July 27, 2028 | Drug product | None | 020873 |
| 7582727*PED | January 27, 2029 | Method of use | None | 020873 |
| 7598343*PED | January 27, 2029 | Method of use | None | 020873 |
Angiomax NDC codes
Questions
Is there a generic for Angiomax?
Yes. The generic name for Angiomax is bivalirudin. 7 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 Angiomax?
The active ingredient in Angiomax is bivalirudin, per the FDA Orange Book.
When does the Angiomax patent expire?
The last patent listed for Angiomax in the Orange Book expires January 27, 2029. 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.