Pyrimethamine

Treats Toxoplasmosis. Sold as Daraprim. Every FDA application for this active ingredient: 1 branded and 4 generic.

As of Nov 14, 2026, FDA lists 5 applications for Pyrimethamine (sold as Daraprim), first approved Jan 23, 1953, with 0 new uses approved and 0 published complete response letters.

First approved: Jan 23, 1953
Applications: 5
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $7.8M

Medicare Spending

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


Pyrimethamine	Part D	$7.2M	-12%	167
Daraprim	Part D	$598K	New	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PYRIMETHAMINE 25 MG TABLET: $137.01 per unitGeneric · -10% in a year

Orphan Designations (FDA)

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

Treatment of GM-2 gangliosidoses (Tay-Sachs disease and Sandhoff disease).ExSAR Corporation · designated Aug 16, 2011

Clinical Trials

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


Combining Latency Reversing Agents to Address the HIV ReservoirHIV (Human Immunodeficiency Virus), HIV -1 Infection · Erasmus Medical Center	Phase 1 / Phase 2	Not yet recruiting	Feb 3, 2026
Perennial Malaria Chemoprevention in the Malaria Vaccine EraMalaria, Falciparum · Stanford University	Phase 4	Not yet recruiting	Jan 7, 2026
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute MalnutritionSevere Acute Malnutrition, Cognitive Impairment · Washington University School of Medicine	Not applicable	Active, not recruiting	Mar 11, 2025
Perennial Malaria Chemoprevention (PMC) Effect StudyMalaria · Malaria Consortium	Not applicable	Active, not recruiting	Dec 4, 2023
Improving Cognition and Gestational Duration With Targeted NutritionMalnutrition in Pregnancy, Preterm Birth · Washington University School of Medicine	Not applicable	Active, not recruiting	Jul 17, 2023
Community-based, Controlled, Open-label, Cluster-randomized Trial for the Reduction of Chronic Malnutrition in Children Under Two Years of Age, With Three Intervention Arms Grouped by Clusters, in Two Provinces in Southern Angola, Huíla and Cunene.Malnutrition, Child · Hospital Universitari Vall d'Hebron Research Institute	Not applicable	Active, not recruiting	Oct 7, 2022
Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in PregnancyMalaria, Malaria in Pregnancy · Menzies School of Health Research	Phase 3	Active, not recruiting	Jun 22, 2022
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm BirthMalaria, Sexually Transmitted Diseases · Tampere University	Phase 3	Active, not recruiting	Aug 17, 2005

Applications

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


Jan 23, 1953	DaraprimNDA 8578 · New molecular entity	Tilde Sciences	9	Marketed
Feb 28, 2020	PyrimethamineANDA 207127	Pharmazone	0	Marketed
Jul 27, 2021	PyrimethamineANDA 211271	Alvogen	0	Discontinued
Aug 13, 2021	PyrimethamineANDA 215506	Teva Pharms	0	Marketed
Oct 25, 2022	PyrimethamineANDA 216983	Aurobindo Pharma Ltd	0	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