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Last Updated: April 28, 2024

METRONIDAZOLE - Generic Drug Details

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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, 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
Hôpital Necker-Enfants Malades	Phase 3
Institut Pasteur	Phase 3
Centre Hospitalier Universitaire de Caen	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
Alembic	METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065-001	Jun 23, 2009	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531-001	Sep 20, 1995	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	METRONIDAZOLE IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	205531-001	May 9, 2017		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cosette	METRONIDAZOLE	metronidazole	GEL;TOPICAL	216692-001	Jan 23, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mutual Pharm	METRONIDAZOLE	metronidazole	TABLET;ORAL	018818-001	Feb 16, 1983		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Halsey	METRONIDAZOLE	metronidazole	TABLET;ORAL	070021-001	Apr 2, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hospira	METRONIDAZOLE IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018890-002	Nov 18, 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
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
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
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	⤷ 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
Australia	2016200825	High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat	⤷ 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
Japan	2014518272		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2009097143		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2019140516		⤷ Try a Trial
Argentina	070406	METODOS Y COMPOSICIONES PARA INCREMENTAR LA SOLUBILIDAD DE COMPUESTOS DE FARMACO AZOL ESCASAMENTE SOLUBLES EN AGUA	⤷ Try a Trial
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)	⤷ 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.