FDA Orange Book · active-ingredient family
Iopamidol
Iopamidol: 2 brands, 12 generics; first approved Dec 31, 1985; generic available.
Generic available4 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 12 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
12
Listed patents
0
Presentations
45
Brand (NDA) products
Originator applications
- ISOVUE-250RLDBRACCONDA 02032719944 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Discontinued — 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Rx — 76% INJECTABLE INJECTION Rx — - BRACCONDA 01873519877 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Rx AP1 61% INJECTABLE INJECTION Rx AP 76% INJECTABLE INJECTION Rx AP 61% INJECTABLE INJECTION Rx AP 26% INJECTABLE INJECTION Discontinued — 41% INJECTABLE INJECTION Rx AP2 51% INJECTABLE INJECTION Rx AP
Generic (ANDA) products (12)
Abbreviated applications
- IOPAMIDOLHAINAN POLYANDA 21713420234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Rx AP2 51% INJECTABLE INJECTION Rx AP 61% INJECTABLE INJECTION Rx AP 76% INJECTABLE INJECTION Rx AP - IOPAMIDOLHAINAN POLYANDA 21538220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Rx AP1 61% INJECTABLE INJECTION Rx AP - SANOCHEMIA CORP USAANDA 09039420102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - COOK IMAGINGANDA 07488120004 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Discontinued — 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07500519983 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07489819974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Discontinued — 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 07463619974 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Discontinued — 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - ABBVIEANDA 0746381997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 61% INJECTABLE INJECTION Discontinued — - HOSPIRAANDA 0746371997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 61% INJECTABLE INJECTION Discontinued — - FRESENIUS KABI USAANDA 07467919973 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 51% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - IOPAMIDOLHOSPIRAANDA 07473419962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — - IOPAMIDOLBAXTER HLTHCAREANDA 07462919964 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 41% INJECTABLE INJECTION Discontinued — 61% INJECTABLE INJECTION Discontinued — 76% INJECTABLE INJECTION Discontinued — 51% INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-975New indication exclusivity (3 years)
in 2 yr
- I-975New indication exclusivity (3 years)
in 2 yr
- I-975New indication exclusivity (3 years)
in 2 yr
- I-975New indication exclusivity (3 years)
in 2 yr
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 5 mo ago
Most recent approval
2 yr 7 mo ago
Approvals span 1985–2024 across 14 FDA applications.
Brand (NDA) 214%
Generic (ANDA) 1286%
Iopamidol: 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.
Go beyond the database.
Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.