Viewing data from:

MATULANE

NDA

PROCARBAZINE HYDROCHLORIDE | N016785 | LEADIANT BIOSCIENCES INC

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 Matulane (2023)

Total Spending

$1.7M

Total Claims

508

Beneficiaries

213

Avg Cost/Unit

$135.35

Spending Trend

$1.5M(2019)→$1.4M(2020)→$1.3M(2021)→$1.7M(2022)→$1.7M(2023)

YoY Change:+9.0%

5yr CAGR:+7.4%

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

API Supply Chain2 active DMFs2 inactive

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

CHEMPACIFIC CORPPROCARBAZINE HYDROCHLORIDE (DRUG SUBSTANCE)

DMF 208782007

CHEMSPEC APIPROCARBAZINE HYDROCHLORIDE

DMF 255902012

HOFFMANN LA ROCHE INCInactivePROCARBAZINE HYDROCHLORIDE PARENTERAL

DMF 22921974

MYLAN LABORATORIES LTDInactivePROCARBAZINE HYDROCHLORIDE USP

DMF 227662009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 29, 2003	SUPPL -35	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.