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Last Updated: December 3, 2022

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 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

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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
Alembic Labs METRONIDAZOLE metronidazole TABLET;ORAL 208681-002 Jun 20, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chemo Research Sl NUVESSA metronidazole GEL;VAGINAL 205223-001 Mar 24, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Halsey METRONIDAZOLE metronidazole TABLET;ORAL 070593-001 Feb 27, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Able METRONIDAZOLE metronidazole TABLET;ORAL 076519-001 Jun 27, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Galderma Labs Lp METROCREAM metronidazole CREAM;TOPICAL 020531-001 Sep 20, 1995 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fosun Pharma METRONIDAZOLE metronidazole TABLET;ORAL 018740-002 Oct 22, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mutual Pharm METRONIDAZOLE metronidazole TABLET;ORAL 018818-001 Feb 16, 1983 DISCN No No 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

International Patents for metronidazole

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