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Last Updated: April 19, 2024

Metronidazole - Generic Drug Details

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What are the generic 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, Cosette, Fougera Pharms, Zydus Lifesciences, Bausch, Encube, Taro, 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, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, 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 nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Summary for metronidazole

International Patents:	21
US Patents:	9
Tradenames:	20
Applicants:	53
NDAs:	87
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	513
Patent Applications:	7,344
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

Drug Sales Revenue Trends for metronidazole

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Recent Clinical Trials for metronidazole

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

Sponsor	Phase
Institut Pasteur	Phase 3
Centre Hospitalier Universitaire de Caen	Phase 3
Ministry of Health, France	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	FLAGYL	metronidazole	TABLET;ORAL	012623-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	018764-002	Dec 20, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	018599-001	Sep 17, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ortho Mcneil Pharm	PROTOSTAT	metronidazole	TABLET;ORAL	018871-001	Mar 2, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	209096-001	Sep 12, 2017	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
B Braun	METRO I.V. IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018900-001	Sep 29, 1983	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for metronidazole

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

International Patents for metronidazole

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Country	Patent Number	Title	Estimated Expiration
China	103763925	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis	⤷ Try a Trial
Canada	3087789	FORMULATIONS ORALES DE METRONIDAZOLE ET METHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL A CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)	⤷ Try a Trial
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana	⤷ Try a Trial
Brazil	112020014376	composição farmacêutica oral, e, método para tratar uma infecção em um paciente.	⤷ Try a Trial
European Patent Office	3768321	FORMULATIONS ORALES DE MÉTRONIDAZOLE ET MÉTHODES DE TRAITEMENT D'UNE INFECTION FAISANT APPEL À CELLES-CI (ORAL FORMULATIONS OF METRONIDAZOLE AND METHODS OF TREATING AN INFECTION USING SAME)	⤷ Try a Trial
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)	⤷ Try a Trial
Australia	2012275292	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat bacterial vaginosis	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for metronidazole

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0328535	96C0021	Belgium	⤷ Try a Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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