Drug

Sodium iodide

As of the edition of 20 October 2026, Sodium iodide is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 1999
Kind
Small molecule
Brand name
Iodotope
First approved
1 January 1982 (US)
Approvals on record
23 in 2 regions
Holder of the most recent approval
Jubilant DraxImage; 8 holders in all
Registered trials
5, 1 stopped early
Disease areas
Heart and blood vessels; Cancer; Hormones; Nervous system

US protection

No US protection is listed.

The FDA registers list no drug-substance patent or exclusivity that counts for this drug.

This is the US only.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 23101
Phase 31100
Phase 41100
All trials5

Who has held its approvals

CompanyRoleYears
DraximageLater holder2003 to now
Bracco DiagnosticsAcquired holder2003 to now
Cis Bioindustries CompagnieAcquired holder2003 to now
Cardinal Health 418Acquired holder2015 to now
CuriumAcquired holder2019 to now
Jubilant DraxImageAcquired holder2020 to now
SUN Pharmaceutical IndustriesAcquired holder2025 to now
Bristol Myers SquibbEarlier holder
Byk-Mallinckrodt CILLater holder
GE HealthcareLater holder