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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

290 trials from ClinicalTrials.gov — 11 recruiting, 3 active, 186 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Metronidazole- Versus Tinidazole-Based Bismuth Quadruple Therapy for Helicobacter Pylori Eradication NCT07746934	N/A	Not Yet Recruiting	University of Medicine and Pharmacy at Ho Chi Minh City	600	2026-07-27 → 2027-12-27
Efficacy And Safety of Bismuth-Tetracycline-Rabeprazole Triple For First-Line Eradication of Helicobacter Pylori Infection NCT07788053	N/A	Not Yet Recruiting	Chih-An Shih, MD	300	2026-09-01 → 2029-09-01
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	2026-08-03 → 2029-08-03
AUTOP 2: Screen-and-treat Strategy for Vaginal Flora Abnormalities by Molecular Biology in Pregnant Women at High Risk of Preterm Birth NCT06349122	Phase 3	Not Yet Recruiting	Assistance Publique Hopitaux De Marseille	1,794	2026-10 → 2029-06
Vaginal Microbiota Transplant NCT04046900	Phase 1/2	Recruiting	Douglas Kwon	62	2021-04-22 → 2027-06-30
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)NCT07492134	Phase 2	Recruiting	Vanderbilt University Medical Center	100	2026-07-07 → 2028-10-01

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

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.