METRONIDAZOLE - Generic Drug Details

What are the generic drug sources for metronidazole and what is the scope of freedom to operate?

Metronidazole is the generic ingredient in twenty branded drugs marketed by Pfizer, Able, Alembic, Chartwell Rx, Galderma Labs Lp, Aurobindo Pharma Ltd, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Encube, Taro, Glenmark Pharms Ltd, Padagis Israel, Sciegen Pharms, Solaris Pharma Corp, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Hikma, Intl Medication, Watson Labs, Amneal, Baxter Hlthcare Corp, Gland, Hospira, Inforlife, Rising, Saptalis Pharms, Labs Af, Alembic Pharms Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Novitium Pharma, Pliva, Somerset Theraps Llc, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in ninety-two NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has twenty-two patent family members in nine countries.

There are eighteen drug master file entries for metronidazole. Sixty-eight suppliers are listed for this compound.

Summary for METRONIDAZOLE

International Patents:	22
US Patents:	9
Tradenames:	20
Applicants:	55
NDAs:	92
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	68
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	589
Drug Prices:	Drug price trends for METRONIDAZOLE
Drug Sales Revenues:	Drug sales revenues for METRONIDAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for METRONIDAZOLE
What excipients (inactive ingredients) are in METRONIDAZOLE?	METRONIDAZOLE excipients list
DailyMed Link:	METRONIDAZOLE at DailyMed

See drug prices for METRONIDAZOLE

See drug sales revenues for METRONIDAZOLE

Recent Clinical Trials for METRONIDAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Universitt Luzern	PHASE4
Faiz ur rahman	NA
Stanford University	EARLY_PHASE1

See all METRONIDAZOLE clinical trials

Pharmacology for METRONIDAZOLE

Drug Class

Nitroimidazole Antimicrobial

Medical Subject Heading (MeSH) Categories for METRONIDAZOLE

Anti-Infective Agents

Antiprotozoal Agents

Radiation-Sensitizing Agents

Anatomical Therapeutic Chemical (ATC) Classes for METRONIDAZOLE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

D06BX	Other chemotherapeutics
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01XD	Imidazole derivatives
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

P01AB	Nitroimidazole derivatives
P01A	AGENTS AGAINST AMOEBIASIS AND OTHER PROTOZOAL DISEASES
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for METRONIDAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LIKMEZ	Oral Suspension	metronidazole	500 mg/5 mL	216755	1	2025-11-13
NUVESSA	Vaginal Gel	metronidazole	1.30%	205223	1	2022-03-30
METROGEL	Topical Gel	metronidazole	1%	021789	1	2008-10-21
METROGEL-VAGINAL	Vaginal Gel	metronidazole	0.75%	020208	1	2004-09-02

US Patents and Regulatory Information for METRONIDAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbott	METRONIDAZOLE	metronidazole	INJECTABLE;INJECTION	018889-001	Nov 18, 1983		DISCN	No	No
Pfizer	FLAGYL	metronidazole	TABLET;ORAL	012623-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes
Novitium Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	208162-001	May 25, 2016	AB	RX	No	No
Zydus Lifesciences	METRONIDAZOLE	metronidazole	GEL;TOPICAL	220095-001	Feb 13, 2026	AB	RX	No	No
Strides Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	070040-001	Jan 29, 1985		DISCN	No	No
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992		DISCN	Yes	No

Expired US Patents for METRONIDAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005	7,456,207
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	7,348,317
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988	4,837,378
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,840,744
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	4,837,378
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	5,536,743
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997	6,103,262

International Patents for METRONIDAZOLE

Country	Patent Number	Title	Estimated Expiration
China	107823123	高剂量粘膜粘附甲硝唑水基凝胶制剂及其治疗细菌性阴道病的用途 (High dosage mucoadhesive metronidazole aqueous-based gel formulations and use to treat bacterial vaginosis)
World Intellectual Property Organization (WIPO)	2013003646
World Intellectual Property Organization (WIPO)	2019140516
Mexico	2014000066	FORMULACIONES MUCOADHESIVAS EN GEL DE ALTA DOSIFICACIÓN DE METRONIDAZOL DE BASE ACUOSA Y SU USO PARA TRATAR LA VAGINOSIS BACTERIANA. (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS.)
Japan	5986632
China	107823123
Japan	2017014248	高用量粘膜接着性メトロニダゾール水系ゲル製剤および細菌性膣炎を治療するためのそれらの使用 (HIGH-DOSE MUCOADHESIVE METRONIDAZOLE AQUEOUS GEL PREPARATION, AND USE OF THE SAME FOR TREATING BACTERIAL VAGINOSIS)

Supplementary Protection Certificates for METRONIDAZOLE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209