Viewing data from:

METROGEL

NDA

METRONIDAZOLE | N019737 | GALDERMA LABORATORIES LP

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 RNB Pharmaceutical Company FDA-1995-P-0011 RNB Pharmaceutical Company filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA Commissioner determine ANDA suitability for a topical lotion formulation containing metronidazole 0.75% for treating rosacea, with the proposed p	Other	2017-09-27	Granted	RNB Pharmaceutical Company

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Metrogel (2023)

Total Spending

$151K

Total Claims

319

Beneficiaries

165

Avg Cost/Unit

$6.36

Spending Trend

$303K(2019)→$257K(2020)→$219K(2021)→$194K(2022)→$151K(2023)

YoY Change:+2.7%

5yr CAGR:+9.2%

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

API Supply Chain2 active DMFs15 inactive

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

CORDEN PHARMA BERGAMO SPAMETRONIDAZOLE USP

DMF 36091979

UNICHEM LABORATORIES LTDMETRONIDAZOLE USP

DMF 162632002

RHONE POULENC INCInactiveMETRONIDAZOLE

DMF 7801964

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveMETRONIDAZOLE

DMF 21861973

UNIQUE CHEMICALSInactiveMETRONIDAZOLE

DMF 36751979

MCGAW INCInactiveMETRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES

DMF 39041980

MEDIMPEX NORTH AMERICA INCInactiveMETRONIDAZOLE USP XX

DMF 46721982

TIANJIN HEBEI PHARMACEUTICAL FACTORYInactiveMETRONIDAZOLE

DMF 49271983

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE USP

DMF 57831985

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE BENZOATE

DMF 63561986

FDC PRIVATE LTDInactiveMETRONIDAZOLE U.S.P. XXI

DMF 70241987

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveMETRONIDAZOLE

DMF 92941991

SIFAVITOR SRLInactiveMETRONIDAZOLE BENZOATE

DMF 94061991

TIANJIN ZHONGAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 163802003

HEC PHARM COInactiveMETRONIDAZOLE USP, NON-STERILE BULK FORM

DMF 194422006

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 234212009

HUBEI HONGYUAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 266582012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 3, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Nov 22, 1988

No patent or exclusivity listings for this strength.