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FLAGYL

NDA

METRONIDAZOLE | N012623 | PFIZER INC

2 strengths0 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Innogenix, LLC FDA-2024-P-2513 · 4 docket documents Innogenix LLC filed this petition pursuant to sections 505(j) and 505(w) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. §§ 314.122 and 314.161 requesting that FDA determine whether the reference listed drug Flagyl (metronidazole) Tablets 250 mg and 500 mg, approved under NDA N012623 and h	505(q)	2024-05-23	Denied	Innogenix, LLC
Citizen Petition from RNB Pharmaceutical Company FDA-1995-P-0011 · 5 docket documents 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

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.

Medicare Part D Spending

CMS annual spending data for Flagyl (2024)

Total Spending

$993.60

Total Claims

Beneficiaries

—

Avg Cost/Unit

$6.45

Spending Trend

$4K(2020)→$3K(2021)→$993.60(2024)

5yr CAGR:+42.9%

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

10 letters from Drugs@FDA

Date	Submission	Document
Jul 9, 2024	SUPPL -72	View Letter (PDF)
Oct 10, 2023	SUPPL -70	View Letter (PDF)
Dec 20, 2021	SUPPL -69	View Letter (PDF)
Mar 9, 2021	SUPPL -68	View Letter (PDF)
Apr 5, 2018	SUPPL -67	View Letter (PDF)
Jul 15, 2015	SUPPL -66	View Letter (PDF)
Aug 20, 2013	SUPPL -65	View Letter (PDF)
Aug 24, 2010	SUPPL -61	View Letter (PDF)
Mar 24, 2004	SUPPL -59	View Letter (PDF)
May 28, 2003	SUPPL -58	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

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