Metronidazole - Generic Drug Details

What are the generic sources for metronidazole and what is the scope of patent protection?

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, 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-seven 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:	67
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	589
Patent Applications:	7,019
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
Medical College of Wisconsin	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
Cosette	METRONIDAZOLE	metronidazole	CREAM;TOPICAL	077549-001	Dec 19, 2007	AB	RX	No	No
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988		DISCN	Yes	No
Aurobindo Pharma Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	203974-001	May 29, 2015	AB	RX	No	No
Strides Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	070039-001	Jan 29, 1985		DISCN	No	No
Glenmark Pharms Ltd	METRONIDAZOLE	metronidazole	GEL;VAGINAL	215794-001	Jan 27, 2022	AB	RX	No	No

Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005
Teva Pharms	VANDAZOLE	metronidazole	GEL;VAGINAL	021806-001	May 20, 2005

International Patents for metronidazole

Country	Patent Number	Title	Estimated Expiration
Australia	2012275292
Australia	2016200825	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana
Canada	2840571	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT BACTERIAL VAGINOSIS)
Canada	3054236	FORMULATIONS DE GEL A BASE DE METRONIDAZOLE AQUEUX MUCOADHESIF A DOSAGE ELEVE ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTERIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS AND THEIR USE TO TREAT 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