Drug

Pralidoxime

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

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

The drug

Status
Marketed; latest approval 1997
Kind
Small molecule
Brand name
Protopam Chloride
First approved
1 January 1982 (US)
Approvals on record
7 in 2 regions
Holder of the most recent approval
Pfizer; 6 holders in all
Registered trials
4, 0 stopped early
Disease areas
Chemically induced

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.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Pralidoxime.

Target

GeneProteinUniProt
ACHEAcetylcholinesteraseP22303

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3210
Phase 21100
All trials4

Who has held its approvals

CompanyRoleYears
PfizerAcquired holder and Earlier holder2003 to now
Baxter HealthcareAcquired holder2003 to now