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, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Encube, Taro, Tolmar, Glenmark Pharms Ltd, Padagis Israel, 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 Pharma Ltd, Hospira, Inforlife, Rising, Saptalis Pharms, Labs Af, Alembic Pharms Ltd, Amici, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in eighty-seven NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has sixteen patent family members in nine countries.

There are eighteen drug master file entries for metronidazole. Seventy-four suppliers are listed for this compound.

Summary for metronidazole

International Patents:	16
US Patents:	8
Tradenames:	20
Applicants:	54
NDAs:	87
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	74
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	513
Patent Applications:	7,361
Formulation / Manufacturing:	see details
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
Ministry of Health, France	Phase 3
Hôpital Necker-Enfants Malades	Phase 3
Institut Pasteur	Phase 3

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
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
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	018764-002	Dec 20, 1982		DISCN	No	No
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	070035-001	Dec 20, 1984	AB	RX	No	No
Strides Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	208162-001	May 25, 2016	AB	RX	No	No
Halsey	METRONIDAZOLE	metronidazole	TABLET;ORAL	070021-001	Apr 2, 1985		DISCN	No	No
Baxter Hlthcare Corp	METRONIDAZOLE IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	078084-001	Mar 31, 2008	AP	RX	No	No
Amici	METRONIDAZOLE	metronidazole	TABLET;ORAL	070772-001	Jul 16, 1986	AB	RX	No	No

Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
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	021789-001	Jun 30, 2005

International Patents for metronidazole

Country	Patent Number	Title	Estimated Expiration
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)
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.)
Australia	2012275292	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis
World Intellectual Property Organization (WIPO)	2009097143
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)
China	103763925	High dosage mucoadhesive metronidazole aqueous-based gel formulations 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