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Last Updated: July 6, 2020

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METRONIDAZOLE - Generic Drug Details

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

Metronidazole is the generic ingredient in nineteen branded drugs marketed by Gd Searle Llc, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Acp Nimble, Fougera Pharms, Valeant Pharms North, Taro, Tolmar, Bausch, Perrigo Uk Finco, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, Pfizer, B Braun, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Baxter Hlthcare Corp, Hospira, Inforlife, Mylan Labs Ltd, Labs Af, 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, Orit Labs Llc, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in seventy-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 forty-four patent family members in nineteen countries.

There are eighteen drug master file entries for metronidazole. Fifty-nine 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
University of Auckland, New ZealandPhase 2/Phase 3
Slovenian Society for Gastroenterology and HepatologyN/A
KRKAN/A

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Pharmacology for METRONIDAZOLE
Medical Subject Heading (MeSH) Categories for METRONIDAZOLE
Paragraph IV (Patent) Challenges for METRONIDAZOLE
Tradename Dosage Ingredient NDA Submissiondate
METROGEL GEL;TOPICAL metronidazole 021789 2008-10-21
METROGEL-VAGINAL GEL;VAGINAL metronidazole 020208 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
Halsey METRONIDAZOLE metronidazole TABLET;ORAL 070593-001 Feb 27, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Taro METRONIDAZOLE metronidazole GEL;TOPICAL 077819-001 Jul 18, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd METRONIDAZOLE metronidazole TABLET;ORAL 203974-001 May 29, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Mutual Pharm METRONIDAZOLE metronidazole TABLET;ORAL 018818-001 Feb 16, 1983 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992   Start Trial   Start Trial
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992   Start Trial   Start Trial
Gd Searle Llc FLAGYL ER metronidazole TABLET, EXTENDED RELEASE;ORAL 020868-001 Nov 26, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for METRONIDAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0328535 96C0021 Belgium   Start 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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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Colorcon
Johnson and Johnson
Boehringer Ingelheim
Merck

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