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Last Updated: March 3, 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
Superpharm METRONIDAZOLE metronidazole TABLET;ORAL 070008-001 Dec 11, 1984 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cosette METRONIDAZOLE metronidazole CREAM;TOPICAL 077549-001 Dec 19, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer FLAGYL ER metronidazole TABLET, EXTENDED RELEASE;ORAL 020868-001 Nov 26, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun METRO I.V. metronidazole INJECTABLE;INJECTION 018674-001 Aug 31, 1982 DISCN 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
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

Country Patent Number Title Estimated Expiration
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
Japan 2014518272 ⤷  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
World Intellectual Property Organization (WIPO) 2019140516 ⤷  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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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.