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Serving leading biopharmaceutical companies globally:

Fish and Richardson
US Department of Justice
Cipla
Daiichi Sankyo
McKinsey
Mallinckrodt
Accenture
Medtronic
Dow
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Generated: October 21, 2017

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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 metronidazole freedom to operate?

Metronidazole
is the generic ingredient in nineteen branded drugs marketed by B Braun, Galderma Labs Lp, Tolmar, Intl Medication, Able, Teva Pharms, West-ward Pharms Int, Fougera Pharms, Medicis, Superpharm, Flamingo Pharms, Ivax Sub Teva Pharms, Mutual Pharm, Taro, Sandoz, Halsey, Par Pharm, Alembic Pharms Ltd, Chemo Research Sl, Gd Searle Llc, Labs Af, Teva Pharms Usa, LNK, Savage Labs, Chartwell Molecules, Mylan Labs Ltd, Pliva, Watson Labs, Vivimed Global, Valeant Pharms North, Watson Labs Inc, Appco Pharma Llc, G And W Labs, Taro Pharm, Pfizer, Baxter Hlthcare, Unichem Labs Ltd, Zydus Pharms Usa Inc, Strides Pharma, Abraxis Pharm, Ortho Mcneil Pharm, Innogenix, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Baxter Hlthcare Corp, Abbott, Hospira, and Lupin Ltd, and is included in seventy-five NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has forty-one patent family members in nineteen countries and one supplementary protection certificate in one country.

There are eighteen drug master file entries for metronidazole. Eighty-four suppliers are listed for this compound.

Summary for Generic Name: metronidazole

US Patents:8
Tradenames:19
Applicants:49
NDAs:75
Drug Master File Entries: see list18
Suppliers / Packagers: see list84
Bulk Api Vendors: see list110
Clinical Trials: see list295
Patent Applications: see list9,407
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:metronidazole at DailyMed

Pharmacology for Ingredient: metronidazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Innogenix
METRONIDAZOLE
metronidazole
TABLET;ORAL070773-001Jul 16, 1986ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
METRONIDAZOLE
metronidazole
TABLET;ORAL203974-001May 29, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Abbott
METRONIDAZOLE
metronidazole
INJECTABLE;INJECTION018889-001Nov 18, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Baxter Hlthcare Corp
METRONIDAZOLE IN PLASTIC CONTAINER
metronidazole
INJECTABLE;INJECTION078084-001Mar 31, 2008APRXNoNo► Subscribe► Subscribe► Subscribe
Tolmar
METRONIDAZOLE
metronidazole
GEL;TOPICAL090903-001Jul 22, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Gd Searle Llc
FLAGYL
metronidazole
CAPSULE;ORAL020334-001May 3, 1995ABRXYesYes► Subscribe► Subscribe► Subscribe
Ortho Mcneil Pharm
PROTOSTAT
metronidazole
TABLET;ORAL018871-001Mar 2, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
METROLOTION
metronidazole
LOTION;TOPICAL020901-001Nov 24, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Watson Labs
METRONIDAZOLE
metronidazole
TABLET;ORAL018764-002Dec 20, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Taro Pharm
METRONIDAZOLE
metronidazole
GEL;TOPICAL204651-001Mar 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: metronidazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gd Searle Llc
FLAGYL ER
metronidazole
TABLET, EXTENDED RELEASE;ORAL020868-001Nov 26, 1997► Subscribe► Subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988► Subscribe► Subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
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International Patent Family for Ingredient: metronidazole

Country Document Number Estimated Expiration
Japan2017014248► Subscribe
Mexico2014000066► Subscribe
Australia2002340458► Subscribe
European Patent Office2725904► Subscribe
Austria481105► Subscribe
MexicoPA04006210► Subscribe
European Patent Office2238980► Subscribe
Australia2012275292► Subscribe
Russian Federation2284810► Subscribe
BrazilPI0215331► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: METRONIDAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021Belgium► SubscribePRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209
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Serving leading biopharmaceutical companies globally:

Queensland Health
Colorcon
Baxter
US Army
Deloitte
Citi
Merck
Covington
Dow
Fuji

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 verifification 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.

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