FDA Orange Book · active-ingredient family
Iohexol
Iohexol: 3 brands, 1 generic; first approved Dec 26, 1985; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
1
Listed patents
0
Presentations
15
Brand (NDA) products
Originator applications
- GE HEALTHCARENDA 01895619889 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 38.8% SOLUTION INJECTION, ORAL, RECTAL Rx — 51.8% SOLUTION INJECTION, ORAL, RECTAL Rx — 64.7% SOLUTION INJECTION, ORAL, RECTAL Rx AP 75.5% SOLUTION INJECTION, ORAL Rx AP 30.2% INJECTABLE INJECTION Rx — 45.3% INJECTABLE INJECTION Discontinued — 15.1% SOLUTION URETHRAL Discontinued — 1.9% SOLUTION ORAL Rx — 2.6% SOLUTION ORAL Rx — - INTERPHARMA PRAHA ASNDA 2053832015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 9.7GM/BOT FOR SOLUTION ORAL Discontinued — - GE HEALTHCARENDA 02060819953 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 51.8% SOLUTION INJECTION, ORAL, RECTAL Discontinued — 64.7% SOLUTION INJECTION, ORAL, RECTAL Rx — 75.5% SOLUTION INJECTION, ORAL Rx —
Generic (ANDA) products (1)
Abbreviated applications
- IOHEXOLAMNEALANDA 21773720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 64.7% SOLUTION INJECTION, ORAL, RECTAL Rx AP 75.5% SOLUTION INJECTION, ORAL Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
9 d ago
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
41 yr 2 mo ago
Most recent approval
1 mo ago
Approvals span 1985–2026 across 4 FDA applications.
Brand (NDA) 375%
Generic (ANDA) 125%
Iohexol: 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.
