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FLAGYL

NDA

METRONIDAZOLE | N020334 | PFIZER 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

300 trials from ClinicalTrials.gov — 20 recruiting, 4 active, 186 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics of Transdermal Metronidazole NCT05929794	Phase 4	Active	University of Iowa	24	2024-02-26 → 2026-12-31
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
Evaluation of Different Medicaments in the Management of Necrotic Primary Molars by Lesion Sterilization and Tissue Repair NCT06926322	N/A	By Invitation	Ain Shams University	108	2025-07-01 → 2030-08
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis NCT07833176	N/A	Not Yet Recruiting	Khyber Medical University Peshawar	240	2026-09-25 → 2027-10-20
Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess NCT07704359	Phase 4	Not Yet Recruiting	University of Illinois at Chicago	236	2026-10-05 → 2029-08-03
Efficacy of Diloxanide Furoate as Additional Luminal Agent Along With Metronidazole for the Treatment of Amoebic Liver Abscess NCT07807150	Phase 3	Not Yet Recruiting	Post Graduate Institute of Medical Education and Research, Chandigarh	220	2026-09-04 → 2027-07-31
Piperacillin/Tazobactam Versus Ceftriaxone and Metronidazole for Children With Perforated Appendicitis NCT07869095	Phase 3	Not Yet Recruiting	McMaster Children's Hospital	180	2027-04 → 2031-12

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

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 -15	View Letter (PDF)
Oct 10, 2023	SUPPL -13	View Letter (PDF)
Dec 20, 2021	SUPPL -12	View Letter (PDF)
Mar 9, 2021	SUPPL -11	View Letter (PDF)
Apr 5, 2018	SUPPL -10	View Letter (PDF)
Jul 14, 2015	SUPPL -9	View Letter (PDF)
Aug 20, 2013	SUPPL -8	View Letter (PDF)
Aug 24, 2010	SUPPL -4	View Letter (PDF)
Mar 24, 2004	SUPPL -3	View Letter (PDF)
May 29, 2003	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 375MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 3, 1995

No patent or exclusivity listings for this strength.