FDA Orange Book
Generic for Gadavist
Gadavist contains gadobutrol. 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 Gadavist is gadobutrol. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Gadavist products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1.20944GM/2ML (604.72MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 18.1416GM/30ML (604.72MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 39.3068GM/65ML (604.72MG/ML) | Marketed (Rx) | AP | 3 | AP |
| solution, intravenous | 4.5354GM/7.5ML (604.72MG/ML) | Marketed (Rx) | AP | 4 | AP |
| solution, intravenous | 6.0472GM/10ML (604.72MG/ML) | Marketed (Rx) | AP | 4 | AP |
| solution, intravenous | 9.0708GM/15ML (604.72MG/ML) | Marketed (Rx) | AP | 4 | AP |
NDA 201277, 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.
Approved generic gadobutrol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 216081 | AP (A-rated, therapeutically equivalent) | September 8, 2023 | 18.1416GM/30ML (604.72MG/ML), 39.3068GM/65ML (604.72MG/ML) |
| HAINAN POLY PHARMACEUTICAL CO LTD | 217480 | AP (A-rated, therapeutically equivalent) | April 16, 2025 | 1.20944GM/2ML (604.72MG/ML), 18.1416GM/30ML (604.72MG/ML), 39.3068GM/65ML (604.72MG/ML), 4.5354GM/7.5ML (604.72MG/ML), 6.0472GM/10ML (604.72MG/ML), 9.0708GM/15ML (604.72MG/ML) |
| ZENARA PHARMA PRIVATE LTD | 219146 | AP (A-rated, therapeutically equivalent) | June 8, 2026 | 1.20944GM/2ML (604.72MG/ML), 18.1416GM/30ML (604.72MG/ML), 39.3068GM/65ML (604.72MG/ML), 4.5354GM/7.5ML (604.72MG/ML), 6.0472GM/10ML (604.72MG/ML), 9.0708GM/15ML (604.72MG/ML) |
| VIWIT PHARMACEUTICAL CO LTD | 219287 | AP (A-rated, therapeutically equivalent) | June 11, 2026 | 4.5354GM/7.5ML (604.72MG/ML), 6.0472GM/10ML (604.72MG/ML), 9.0708GM/15ML (604.72MG/ML) |
| GE HEALTHCARE INC | 215957 | AP (A-rated, therapeutically equivalent) | June 29, 2026 | 1.20944GM/2ML (604.72MG/ML), 4.5354GM/7.5ML (604.72MG/ML), 6.0472GM/10ML (604.72MG/ML), 9.0708GM/15ML (604.72MG/ML) |
Gadavist NDC codes
Questions
Is there a generic for Gadavist?
Yes. The generic name for Gadavist is gadobutrol. 5 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 Gadavist?
The active ingredient in Gadavist is gadobutrol, 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.