FDA Orange Book · active-ingredient family
Gadoxetate disodium
Gadoxetate disodium: 1 brand, 0 generics; first approved Jul 03, 2008.
Brand only
Generic status & protection
No listed patents or exclusivity: brand product(s) only.
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
0
Presentations
2
Brand (NDA) products
Originator applications
- BAYER HLTHCARENDA 02209020082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.8143GM/10ML (181.43MG/ML) SOLUTION INTRAVENOUS Rx — 2.72145GM/15ML (181.43MG/ML) SOLUTION INTRAVENOUS Rx —
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
18 yr 4 mo ago
Most recent approval
13 yr 8 mo ago
Approvals span 2008–2013 across 1 FDA application.
Brand (NDA) 1100%
Generic (ANDA) 00%
Gadoxetate disodium: 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.
