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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for 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 (2023). 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.