Metronidazole - Generic Drug Details

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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, 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-eight 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. Seventy-two suppliers are listed for this compound.

Summary for metronidazole

International Patents:	21
US Patents:	9
Tradenames:	20
Applicants:	53
NDAs:	88
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	72
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	526
Patent Applications:	7,017
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

See drug sales revenues for metronidazole

Recent Clinical Trials for metronidazole

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

Sponsor	Phase
Hospital Universitario Evangelico de Curitiba	Phase 3
National Institute of Dental and Craniofacial Research (NIDCR)	Phase 3
National Dental PBRN	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

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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
Lupin Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	209096-001	Sep 12, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Solaris Pharma Corp	METRONIDAZOLE	metronidazole	GEL;VAGINAL	213648-001	Oct 14, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Labs Af	METROMIDOL	metronidazole	TABLET;ORAL	074523-001	Oct 24, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	METRONIDAZOLE HYDROCHLORIDE	metronidazole hydrochloride	INJECTABLE;INJECTION	070295-001	Oct 15, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	METRONIDAZOLE	metronidazole	CAPSULE;ORAL	079065-001	Jun 23, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	METRONIDAZOLE	metronidazole	INJECTABLE;INJECTION	070071-001	Dec 3, 1984		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Able	METRONIDAZOLE	metronidazole	TABLET;ORAL	076519-002	Jun 27, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988	⤷ Sign Up	⤷ Sign Up
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	⤷ Sign Up	⤷ Sign Up
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	⤷ Sign Up	⤷ Sign Up
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992	⤷ Sign Up	⤷ Sign Up
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005	⤷ Sign Up	⤷ Sign Up
>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	⤷ Sign Up
Brazil	112020014376	composição farmacêutica oral, e, método para tratar uma infecção em um paciente.	⤷ Sign Up
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)	⤷ Sign Up
Japan	6235087		⤷ Sign Up
Argentina	070406	METODOS Y COMPOSICIONES PARA INCREMENTAR LA SOLUBILIDAD DE COMPUESTOS DE FARMACO AZOL ESCASAMENTE SOLUBLES EN AGUA	⤷ Sign Up
Japan	2014518272		⤷ Sign Up
European Patent Office	2725904	FORMULATIONS DE GEL À BASE DE MÉTRONIDAZOLE AQUEUX MUCOADHÉSIF À DOSAGE ÉLEVÉ ET LEUR UTILISATION POUR TRAITER UNE VAGINOSE BACTÉRIENNE (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS)	⤷ Sign Up
>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	⤷ Sign Up	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.