FDA Orange Book
Is there a generic for Angiomax Rtu?
Angiomax Rtu 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Angiomax Rtu (bivalirudin). The Orange Book shows its last listed patent expires May 20, 2039.
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Angiomax Rtu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 250MG/50ML (5MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 211215, held by MAIA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Angiomax Rtu patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11903993 | May 20, 2039 | Method of use | U-3817 | 211215 |
| 12472224 | May 20, 2039 | Drug product | U-3817 | 211215 |
| 11918622 | May 20, 2039 | Method of use | U-3817 | 211215 |
| 11992514 | May 20, 2039 | Drug product | None | 211215 |
Angiomax Rtu NDC codes
Questions
Is there a generic for Angiomax Rtu?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Angiomax Rtu (bivalirudin). The Orange Book shows its last listed patent expires May 20, 2039.
What is the generic name for Angiomax Rtu?
The active ingredient in Angiomax Rtu is bivalirudin, per the FDA Orange Book.
When does the Angiomax Rtu patent expire?
The last patent listed for Angiomax Rtu in the Orange Book expires May 20, 2039. 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.