Metronidazole - Generic Drug Details

What are the generic sources for metronidazole and what is the scope of freedom to operate?

Metronidazole is the generic ingredient in nineteen branded drugs marketed by Pfizer, Able, Alembic Pharms Ltd, Strides Pharma, Galderma Labs Lp, Cosette, Fougera Pharms, Bausch, Aleor Dermaceuticals, 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, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Rising, Labs Af, Alembic Labs, 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, Superpharm, Teva Pharms Usa, Unichem, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in eighty-one NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has forty-four patent family members in nineteen countries.

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

Summary for metronidazole

International Patents:	44
US Patents:	10
Tradenames:	19
Applicants:	50
NDAs:	81
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	65
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	491
Patent Applications:	7,411
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
Assiut University	N/A
Icahn School of Medicine at Mount Sinai	Phase 2
King's College London	N/A

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic Labs	METRONIDAZOLE	metronidazole	TABLET;ORAL	208681-002	Jun 20, 2017	AB	RX	No	No
Chemo Research Sl	NUVESSA	metronidazole	GEL;VAGINAL	205223-001	Mar 24, 2014		RX	Yes	Yes			Y
Halsey	METRONIDAZOLE	metronidazole	TABLET;ORAL	070593-001	Feb 27, 1986		DISCN	No	No
Able	METRONIDAZOLE	metronidazole	TABLET;ORAL	076519-001	Jun 27, 2003		DISCN	No	No
Galderma Labs Lp	METROCREAM	metronidazole	CREAM;TOPICAL	020531-001	Sep 20, 1995	AB	RX	Yes	Yes
Fosun Pharma	METRONIDAZOLE	metronidazole	TABLET;ORAL	018740-002	Oct 22, 1982		DISCN	No	No
Mutual Pharm	METRONIDAZOLE	metronidazole	TABLET;ORAL	018818-001	Feb 16, 1983		DISCN	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
Pfizer	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997
Bausch	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	021789-001	Jun 30, 2005

International Patents for metronidazole

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1071514
European Patent Office	2238980
Brazil	112013033759	formulações de gel de base aquosa de metronidazol mucoadeseivo de alta dosagem e seu uso para tratar vaginose bacteriana
World Intellectual Property Organization (WIPO)	2009097143
Japan	6235087
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)
Japan	2005532990

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