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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Department of Justice
Boehringer Ingelheim
Novartis
Moodys
McKesson
US Army
Medtronic
Fuji
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Generated: December 11, 2017

DrugPatentWatch Database Preview

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 Gd Searle Llc, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Fougera Pharms, G And W Labs, Valeant Pharms North, G And W Labs Inc, Taro, Taro Pharm, Tolmar, Medicis, 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, Mylan Labs Ltd, Labs Af, Appco Pharma Llc, Aurobindo Pharma Ltd, Chartwell Molecules, Flamingo Pharms, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Sandoz, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Global, Watson Labs Inc, Zydus Pharms Usa Inc, Ortho Mcneil Pharm, and Savage Labs, 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.

Pharmacology for metronidazole

Medical Subject Heading (MeSH) Categories for metronidazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Chemo Research SlNUVESSAmetronidazoleGEL;VAGINAL205223-001Mar 24, 2014RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Vivimed GlobalMETRONIDAZOLEmetronidazoleTABLET;ORAL070040-001Jan 29, 1985ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Watson LabsMETRONIDAZOLEmetronidazoleINJECTABLE;INJECTION070170-001Apr 1, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin LtdMETRONIDAZOLEmetronidazoleTABLET;ORAL209096-002Sep 12, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
B BraunMETRO I.V. IN PLASTIC CONTAINERmetronidazoleINJECTABLE;INJECTION018900-001Sep 29, 1983APRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
SuperpharmMETRONIDAZOLEmetronidazoleTABLET;ORAL070008-001Dec 11, 1984DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
AbleMETRONIDAZOLEmetronidazoleTABLET;ORAL076519-001Jun 27, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
PlivaMETRONIDAZOLEmetronidazoleTABLET;ORAL070033-001Dec 6, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TolmarMETRONIDAZOLEmetronidazoleGEL;TOPICAL090903-001Jul 22, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
SandozMETRONIDAZOLEmetronidazoleTABLET;ORAL018740-002Oct 22, 1982DISCNNoNo► Subscribe► 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
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL019737-001Nov 22, 1988► Subscribe► Subscribe
MedicisMETROGEL-VAGINALmetronidazoleGEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Gd Searle LlcFLAGYL ERmetronidazoleTABLET, EXTENDED RELEASE;ORAL020868-001Nov 26, 1997► Subscribe► Subscribe
MedicisMETROGEL-VAGINALmetronidazoleGEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
MedicisMETROGEL-VAGINALmetronidazoleGEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
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International Patent Family for Ingredient: metronidazole

Country Document Number Estimated Expiration
Hong Kong1071514► Subscribe
World Intellectual Property Organization (WIPO)2013003646► Subscribe
Russian Federation2413501► Subscribe
European Patent Office2238980► Subscribe
Canada2840571► Subscribe
Portugal1467744► Subscribe
Argentina037755► Subscribe
Japan2017014248► Subscribe
Russian Federation2006116252► Subscribe
Brazil112013033759► 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:

Argus Health
Cipla
Harvard Business School
Cantor Fitzgerald
McKesson
Medtronic
Cerilliant
Express Scripts
Johnson and Johnson
Baxter

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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