Viewing data from:

DARAPRIM

NDA

PYRIMETHAMINE | N008578 | TILDE SCIENCES LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2020-P-1369 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition on behalf of interests seeking to expand generic competition for Pyrimethamine Tablets, 25 mg. The petitioner requests that the FDA designate ANDA 207127 held by Cerovene, Inc. as a new reference standard in the Orange Book because the curre	505(q)	2020-05-11	Withdrawn	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

141 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 114 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Gestational Sulfadoxine-pyrimethamine and Azithromycin Treatment to Prevent Preterm Birth NCT00131235	Phase 3	Active	Tampere University	1,320	2003-12 → 2027-12-31
Pyrimethamine, Sulfadiazine, and Leucovorin in Treating Patients With Congenital Toxoplasmosis NCT00004317	Phase 4	Recruiting	National Institute of Allergy and Infectious Diseases (NIAID)	600	2000-07 → 2030-12
Dose Escalation PfSPZ-CVac NCT03083847	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	55	2017-06-05 → 2019-06-26
Phase 2 Efficacy Study of Primaquine and Methylene Blue NCT02831023	Phase 2	Completed	University of California, San Francisco	80	2016-07 → 2017-01
Optimal Chemopreventive Regimens to Prevent Malaria and Improve Birth Outcomes in Uganda NCT04336189	Phase 3	Completed	Grant Dorsey, M.D, Ph.D.	2,757	2020-12-28 → 2024-07-28
Impact IPT With Sulfadoxine-pyrimethamine or Sulfadoxine-pyrimethamine Plus Piperaquine in Schoolchildren NCT01722539	Phase 3	Completed	Universiteit Antwerpen	616	2012-11 → 2013-11
Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1 NCT02836002	Phase 1/2	Completed	Radboud University Medical Center	29	2016-06 → 2017-06-29
Prevention of Severe Anaemia in Gambian Children NCT00131716	Phase 3	Completed	London School of Hygiene and Tropical Medicine	1,200	2003-05 → 2005-05
Trial of Artesunate Combination Therapy in Pakistan NCT00959517	Phase 2	Completed	London School of Hygiene and Tropical Medicine	588	2001-07 → 2006-08
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS NCT00000674	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	30	— → 1992-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$3607.70

Highest Price

$73869.35

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
83649-0330-01DARAPRIM 25MG TAB	$73869.35	FSS	Tilde Sciences, LLC	02/28/2030
83649-0330-01DARAPRIM 25MG TAB	$51148.38	Big4	Tilde Sciences, LLC	02/28/2030
83649-0330-03DARAPRIM 25MG TAB	$22160.80	FSS	Tilde Sciences, LLC	02/28/2030
83649-0330-03DARAPRIM 25MG TAB	$3607.70	Big4	Tilde Sciences, LLC	02/28/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Pyrimethamine (2024)

Total Spending

$8.2M

Total Claims

515

Beneficiaries

112

Avg Cost/Unit

$290.54

YoY Change:-26.4%

5yr CAGR:-10.9%

Daraprim (2023)

Total Spending

$1.1M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$688.80

Spending Trend

$40.5M(2019)→$30.1M(2020)→$10.4M(2021)→$2.4M(2022)→$1.1M(2023)

YoY Change:-3.5%

5yr CAGR:-2.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs

5 active API suppliers hold Drug Master Files for this ingredient.

FUKUZYU PHARMACEUTICAL CO LTDPYRIMETHAMINE

DMF 99981992

IPCA LABORATORIES LTDPYRIMETHAMINE USP

DMF 228802009

ALVOGEN INCPYRIMETHAMINE

DMF 337592019

INTERQUIM SA DE CVPYRIMETHAMINE

DMF 351212020

APITORIA PHARMA PRIVATE LTDPYRIMETHAMINE USP

DMF 360982021

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 20, 2017	SUPPL -19	View Letter (PDF)
Jun 2, 2004	SUPPL -15	View Letter (PDF)
Nov 25, 2003	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.