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NORITATE

NDA

METRONIDAZOLE | N020743 | BAUSCH HEALTH 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

276 trials from ClinicalTrials.gov — 2 recruiting, 3 active, 183 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Regeneration of Immature Teeth. Case Series NCT03507556	N/A	Active	Jordan University of Science and Technology	40	2010-06-28 → 2030-12-01
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery NCT03663504	Phase 4	Active	Ottawa Hospital Research Institute	630	2018-10-23 → 2026-10
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Vaginal Microbiota Transplant NCT04046900	Phase 1/2	Recruiting	Douglas Kwon	62	2021-04-22 → 2026-09-30
Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).NCT02475733	Phase 2	Completed	Pfizer	83	2015-08-01 → 2017-06-01
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection NCT01473836	Phase 3	Completed	Pfizer	38	2011-11 → 2012-10
A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea NCT01513863	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	602	2011-08 → 2012-09
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies NCT01722708	N/A	Completed	HaEmek Medical Center, Israel	166	2012-11-01 → 2025-12-30
15-day Sequential Therapy for Helicobacter Pylori Infection in Korea NCT01887249	Phase 4	Completed	Seoul National University Bundang Hospital	287	2010-05 → 2013-07

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$1468.93

Highest Price

$1821.11

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00187-5202-60NORITATE 1% CREAM	$1821.11	FSS	Bausch Health US, LLC	04/30/2026
00187-5202-60NORITATE 1% CREAM	$1468.93	Big4	Bausch Health US, LLC	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Noritate (2024)

Total Spending

$3.3M

Total Claims

1,632

Beneficiaries

1,090

Avg Cost/Unit

$31.90

Spending Trend

$3.4M(2019)→$3.3M(2020)→$2.9M(2021)→$3.0M(2022)→$3.0M(2023)→$3.3M(2024)

YoY Change:-4.5%

5yr CAGR:-0.7%

Source: CMS Medicare Part D Spending by Drug (2024). 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

2 letters from Drugs@FDA

Date	Submission	Document
Jul 6, 2004	SUPPL -6	View Letter (PDF)
Apr 18, 2003	SUPPL -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1%

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Sep 26, 1997

No patent or exclusivity listings for this strength.