FDA Orange Book · active-ingredient family
Gadobutrol
Gadobutrol: 1 brand, 5 generics; first approved Mar 14, 2011; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
31
Brand (NDA) products
Originator applications
- BAYER HLTHCARENDA 20127720136 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 18.1416GM/30ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 39.3068GM/65ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 1.20944GM/2ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (5)
Abbreviated applications
- GE HLTHCAREANDA 21595720264 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.20944GM/2ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOBUTROLVIWIT PHARMANDA 21928720263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOBUTROLZENARAANDA 21914620266 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.20944GM/2ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 18.1416GM/30ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 39.3068GM/65ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOBUTROLHAINAN POLY PHARMANDA 21748020256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 1.20944GM/2ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 18.1416GM/30ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 39.3068GM/65ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP - GADOBUTROLHENGRUI PHARMAANDA 21608120226 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 18.1416GM/30ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 39.3068GM/65ML (604.72MG/ML) SOLUTION INTRAVENOUS Rx AP 1.20944GM/2ML (604.72MG/ML) SOLUTION INTRAVENOUS Discontinued — 4.5354GM/7.5ML (604.72MG/ML) SOLUTION INTRAVENOUS Discontinued — 6.0472GM/10ML (604.72MG/ML) SOLUTION INTRAVENOUS Discontinued — 9.0708GM/15ML (604.72MG/ML) SOLUTION INTRAVENOUS Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
15 yr 7 mo ago
Most recent approval
1 mo ago
Approvals span 2011–2026 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Gadobutrol: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
