Viewing data from:

PRIMAQUINE

NDA

PRIMAQUINE PHOSPHATE | N008316 | SANOFI AVENTIS US 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 Primaquine (2023)

Total Spending

$26K

Total Claims

439

Beneficiaries

300

Avg Cost/Unit

$1.60

Spending Trend

$19K(2019)→$14K(2020)→$13K(2021)→$19K(2022)→$26K(2023)

YoY Change:-16.7%

5yr CAGR:-1.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

IPCA LABORATORIES LTDPRIMAQUINE PHOSPHATE USP

DMF 252582011

DEPT DEFENSEInactivePRIMAQUINE

DMF 861940

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

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 15MG BASE

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.