Iopamidol
As of the edition of 20 October 2026, Iopamidol is a small molecule: marketed, first approved in 1985 (US); US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- ISOVUE-300
- First approved
- 31 December 1985 (US)
- Approvals on record
- 13 in 3 regions
- Holder of the most recent approval
- BRACCO IMAGING DO BRASIL IMPORTAÇÃO E DISTRIBUIÇÃO DE MEDICAMEN; 3 holders in all
- Registered trials
- 15, 3 stopped early
- Disease areas
- Cancer; Heart and blood vessels; Hormones; Lungs and airways; Digestive system; Pregnancy and women's health
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Bracco Diagnostics.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product4 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 4 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 2 | 0 | 1 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 2 | 1 | 1 | 0 |
| Phase 4 | 6 | 5 | 0 | 1 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bristol Myers Squibb | Earlier holder | 1985 to now |
| Bracco Diagnostics | Acquired holder and Lead sponsor of trials | 2003 to now |