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 is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:IOMERVU · NDA 216016

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · solution

Product	Applicant	Application	TE	Approved
IOMERVURLD×13	BRACCO	NDA 216016	—	Nov 27, 2024
IOMERVURLD×13	BRACCO	NDA 216017	—	Nov 27, 2024

Marketing exclusivity (26)

NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo
NCENew chemical entity exclusivity (5 years)
Nov 27, 2029
in 3 yr 6 mo

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.

Iomeprol — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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