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Last Updated: March 28, 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. Seventy suppliers are listed for this compound.

Drug Prices for metronidazole

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Drug Sales Revenue Trends for metronidazole

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Recent Clinical Trials for metronidazole

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SponsorPhase
Ministry of Health, FrancePhase 3
Hôpital Necker-Enfants MaladesPhase 3
Institut PasteurPhase 3

See all metronidazole clinical trials

Pharmacology for metronidazole
Medical Subject Heading (MeSH) Categories for metronidazole
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
Strides Pharma METRONIDAZOLE metronidazole TABLET;ORAL 070040-001 Jan 29, 1985 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Halsey METRONIDAZOLE metronidazole TABLET;ORAL 070593-001 Feb 27, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Solaris Pharma Corp METRONIDAZOLE metronidazole GEL;VAGINAL 213648-001 Oct 14, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pliva METRONIDAZOLE metronidazole TABLET;ORAL 070033-001 Dec 6, 1984 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fosun Pharma METRONIDAZOLE metronidazole TABLET;ORAL 018740-001 Oct 22, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fougera Pharms METRONIDAZOLE metronidazole LOTION;TOPICAL 077197-001 May 24, 2006 AB RX No No ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 021789-001 Jun 30, 2005 ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for metronidazole

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2013003646 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009097143 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2019140516 ⤷  Try a Trial
Australia 2016200825 High dosage mucoadhesive metronidazole aqueous-based gel formulations their use to treat ⤷  Try a Trial
Mexico 2020007494 FORMULACIONES ORALES DE METRONIDAZOL Y METODOS DE TRATAMIENTO DE UNA INFECCION CON LAS MISMAS. (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
Japan 6235087 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for metronidazole

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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