Primaquine Phosphate

Sold as Primaquine. Every FDA application for this active ingredient: 1 branded and 3 generic.

As of Nov 15, 2026, FDA lists 4 applications for Primaquine Phosphate (sold as Primaquine), first approved Jan 23, 1952, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 23, 1952
Applications: 4
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $27K
First approved in Japan: Mar 28, 2016

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Primaquine	Part D	$27K	+2%	364

Orphan Designations (FDA)

One designation, 0 approved for the designated use; see all orphan designations

For use in combination with clindamycin hydrochloride in the treatment of Pneumocystis carinii pneumonia associated…Sanofi Winthrop, Inc. · designated Jul 23, 1993

Approvals in Japan (PMDA)

First approved in Japan 770 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Primaquine, new ingredientA drug with a new active ingredient indicated for the treatment of malaria caused by Plasmodium vivax and Plasmodium oval . · Sanofi K.K. · Mar 28, 2016

Clinical Trials

14 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Ethiopian Antimalarial Therapeutic Efficacy Study 2026Plasmodium Vivax Malaria Without Complication, Plasmodium Falciparum Malaria (Uncomplicated) · Ethiopian Public Health Institute	—	Not yet recruiting	Sep 25, 2026
An Ultra-short Course of Primaquine for the Radical Cure of Vivax MalariaMalaria · Menzies School of Health Research	Phase 3	Not yet recruiting	Mar 12, 2026
Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.Vivax Malaria, G6PD Deficiency · Menzies School of Health Research	Phase 4	Recruiting	Mar 12, 2026
Assessing the Feasibility of Combining Dihydroartemisinin Piperaquine and Primaquine for Malaria Mass Drug Administration in High Endemic Communities in the Eastern Region of GhanaMalaria Asymptomatic Parasitaemia, Malaria Falciparum · Noguchi Memorial Institute for Medical Research	Not applicable	Recruiting	Feb 5, 2026
Positioning Second-line Therapies for Pneumocystis Jirovecii Pneumonia (PCP Alternatives)Pneumocystis, Pneumocystis Infection · McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	Not yet recruiting	Jan 21, 2026
MDA and Targeted Control Against Plasmodium Carriage in the SahelMalaria, Falciparum, Malaria, Asymptomatic Parasitaemia · Institut de Recherche pour le Developpement	Not applicable	Active, not recruiting	Dec 15, 2025
Postpartum 8-aminoquinoline Breast Milk StudyDrug Pharmacokinetics in Healthy Volunteers · Curtin University	Phase 2 / Phase 3	Not yet recruiting	Jul 11, 2025
Serological Testing and Treatment for Plasmodium Vivax Malaria: a Trial in Ethiopia and MadagascarMalaria Vivax, Malaria Falciparum · London School of Hygiene and Tropical Medicine	Phase 3	Recruiting	Apr 11, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jan 23, 1952	PrimaquineNDA 8316 · New formulation or manufacturer	Sanofi Aventis US	17	Marketed
Feb 3, 2014	Primaquine PhosphateANDA 203924	Alvogen	2	Discontinued
Feb 25, 2014	Primaquine PhosphateANDA 204476	Unichem	4	Marketed
Jun 23, 2016	Primaquine PhosphateANDA 206043	Ingenus Pharms LLC	4	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA