Is there a generic for Iomeprol?

The FDA Orange Book does not currently list an approved generic (ANDA) for Iomeprol. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Iomeprol?

IOMERVU (NDA 216016, BRACCO) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Does Iomeprol have FDA marketing exclusivity?

Yes. The Orange Book records 26 marketing-exclusivity periods for Iomeprol. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Iomeprol are approved?

Iomeprol is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Iomeprol

Iomeprol: 2 brands, 0 generics; first approved Nov 27, 2024.

Brand only26 exclusivity periodsHas discontinued products

Generic status & protection

Marketing exclusivity runs through Nov 27, 2029.

Latest exclusivity ends Nov 27, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

IOMERVURLD

BRACCONDA 216016202413 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Rx	—
52.5GM IODINE/150ML (350MG IODINE/ML	SOLUTION	INTRA-ARTERIAL	Discontinued	—
70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Rx	—
20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Rx	—
60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Discontinued	—
80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION	INTRA-ARTERIAL	Rx	—

IOMERVURLD

BRACCONDA 216017202413 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25GM IODINE/100ML (250MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
15GM IODINE/50ML (300MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
30GM IODINE/100ML (300MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
45GM IODINE/150ML (300MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
60GM IODINE/200ML (300MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
17.5GM IODINE/50ML (350MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
35GM IODINE/100ML (350MG IODINE/ML)	SOLUTION	INTRAVENOUS	Rx	—
52.5GM IODINE/150ML (350MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
70GM IODINE/200ML (350MG IODINE/ML)	SOLUTION	INTRAVENOUS	Rx	—
20GM IODINE/50ML (400MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
40GM IODINE/100ML (400MG IODINE/ML)	SOLUTION	INTRAVENOUS	Rx	—
60GM IODINE/150ML (400MG IODINE/ML)	SOLUTION	INTRAVENOUS	Discontinued	—
80GM IODINE/200ML (400MG IODINE/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (26)

NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 5 mo

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Nov 27, 2024

1 yr 8 mo ago

Most recent approval

Nov 27, 2024

1 yr 8 mo ago

All 2 applications were approved in 2024.

Brand (NDA) 2100%

Generic (ANDA) 00%

Iomeprol — 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.

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