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Last Updated: July 29, 2021

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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 Pfizer, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Cosette, Fougera Pharms, Valeant Pharms North, Taro, Tolmar, Bausch, Perrigo Uk Finco, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, B Braun, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Inforlife, Mylan Labs Ltd, Labs Af, Alembic Labs, 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 seventy-eight 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-two suppliers are listed for this compound. There is one tentative approval 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
University of LausannePhase 4
Jining No.2 People's HospitalPhase 4
The Affiliated Hospital of Qingdao UniversityPhase 4

See all METRONIDAZOLE clinical trials

Generic filers with tentative approvals for METRONIDAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free1%GEL;TOPICAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Galderma Labs Lp METROCREAM metronidazole CREAM;TOPICAL 020531-001 Sep 20, 1995 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fougera Pharms METRONIDAZOLE metronidazole CREAM;TOPICAL 076408-001 May 28, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Able METRONIDAZOLE metronidazole CAPSULE;ORAL 076505-001 Nov 13, 2003 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Chartwell Molecules METRONIDAZOLE metronidazole TABLET;ORAL 018845-001 Aug 18, 1983 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 it Free ⤷  Try it Free
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 ⤷  Try it Free ⤷  Try it Free
Pfizer FLAGYL ER metronidazole TABLET, EXTENDED RELEASE;ORAL 020868-001 Nov 26, 1997 ⤷  Try it Free ⤷  Try it Free
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free 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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