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Last Updated: October 6, 2022

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 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.

Drug Prices for metronidazole

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Drug Sales Revenue Trends for metronidazole

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Recent Clinical Trials for metronidazole

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

SponsorPhase
Assiut UniversityN/A
Icahn School of Medicine at Mount SinaiPhase 2
King's College LondonN/A

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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
Able METRONIDAZOLE metronidazole TABLET;ORAL 076519-002 Jun 27, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Abbott METRONIDAZOLE metronidazole INJECTABLE;INJECTION 018889-001 Nov 18, 1983 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tolmar METRONIDAZOLE metronidazole GEL;TOPICAL 090903-001 Jul 22, 2011 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Tolmar METRONIDAZOLE metronidazole GEL;TOPICAL 077547-001 Jul 13, 2006 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Pfizer FLAGYL ER metronidazole TABLET, EXTENDED RELEASE;ORAL 020868-001 Nov 26, 1997 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 See Plans and Pricing See Plans and Pricing
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for metronidazole

Country Patent Number Title Estimated Expiration
European Patent Office 2241320 See Plans and Pricing
Mexico 2014000066 FORMULACIONES MUCOADHESIVAS EN GEL DE ALTA DOSIFICACIÓN DE METRONIDAZOL DE BASE ACUOSA Y SU USO PARA TRATAR LA VAGINOSIS BACTERIANA. (HIGH DOSAGE MUCOADHESIVE METRONIDAZOLE AQUEOUS-BASED GEL FORMULATIONS THEIR USE TO TREAT BACTERIAL VAGINOSIS.) See Plans and Pricing
Japan 6235087 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013003646 See Plans and Pricing
Austria 481105 See Plans and Pricing
>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 See Plans and Pricing 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.