FDA Orange Book
Is there a generic for Ambelvist?
Ambelvist contains gadoquatrane. 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 Ambelvist (gadoquatrane). The Orange Book shows its last listed patent expires May 19, 2040 and its last listed exclusivity ends June 12, 2031.
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Ambelvist products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 0.5158GM/2ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 1.93425GM/7.5ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 16.7635GM/65ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 2.579GM/10ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 3.8685GM/15ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 7.737GM/30ML (257.9MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 219627, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ambelvist patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10722601 | May 30, 2036 | Drug substance | U-4424 | 219627 |
| 10137209 | May 30, 2036 | Drug substance | U-4424 | 219627 |
| 12478696 | May 30, 2036 | Drug substance | None | 219627 |
| 11491245 | May 30, 2036 | Drug substance | None | 219627 |
| 12303573 | November 21, 2039 | Drug product | None | 219627 |
| 11944690 | May 19, 2040 | Drug product | None | 219627 |
Ambelvist exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 12, 2031 | 219627 |
Ambelvist NDC codes
Questions
Is there a generic for Ambelvist?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ambelvist (gadoquatrane). The Orange Book shows its last listed patent expires May 19, 2040 and its last listed exclusivity ends June 12, 2031.
What is the generic name for Ambelvist?
The active ingredient in Ambelvist is gadoquatrane, per the FDA Orange Book.
When does the Ambelvist patent expire?
The last patent listed for Ambelvist in the Orange Book expires May 19, 2040. 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.