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Generated: September 22, 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 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, Allied Pharma Inc, Aurobindo Pharma Ltd, G And W Labs Inc, Orit Labs Llc, Baxter Hlthcare Corp, Abbott, and Hospira, and is included in seventy-four 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 thirty-nine patent family members in nineteen countries.

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

Summary for Generic Name: metronidazole

Tradenames:19
Patents:8
Applicants:48
NDAs:74
Drug Master File Entries: see list18
Suppliers / Packagers: see list82
Bulk Api Vendors: see list110
Clinical Trials: see list291
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
Sandoz
METRONIDAZOLE
metronidazole
TABLET;ORAL018740-002Oct 22, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
METRONIDAZOLE
metronidazole
TABLET, EXTENDED RELEASE;ORAL090222-001May 5, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
VANDAZOLE
metronidazole
GEL;VAGINAL021806-001May 20, 2005BXRXNoNo► Subscribe► SubscribeY ► Subscribe
Abraxis Pharm
METRONIDAZOLE HYDROCHLORIDE
metronidazole hydrochloride
INJECTABLE;INJECTION070295-001Oct 15, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Chemo Research Sl
NUVESSA
metronidazole
GEL;VAGINAL205223-001Mar 24, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988ABRXYesYes► Subscribe► Subscribe► Subscribe
Able
METRONIDAZOLE
metronidazole
TABLET, EXTENDED RELEASE;ORAL076462-001Jun 25, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe
Gd Searle Llc
FLAGYL
metronidazole
TABLET;ORAL012623-003Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Sandoz
METRONIDAZOLE
metronidazole
TABLET;ORAL018620-002Jun 2, 1983DISCNNoNo► Subscribe► Subscribe► Subscribe
Taro
METRONIDAZOLE
metronidazole
GEL;TOPICAL077819-001Jul 18, 2006ABRXNoNo► 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
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992► Subscribe► Subscribe
Gd Searle Llc
FLAGYL ER
metronidazole
TABLET, EXTENDED RELEASE;ORAL020868-001Nov 26, 1997► 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
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
Portugal1467744► Subscribe
BrazilPI0215331► Subscribe
Argentina070406► Subscribe
South Korea100718858► Subscribe
Spain2352656► Subscribe
Russian Federation2004122696► Subscribe
Australia2012275292► Subscribe
Argentina037755► Subscribe
World Intellectual Property Organization (WIPO)2013003646► Subscribe
European Patent Office2725904► 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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Argus Health
McKesson
QuintilesIMS
Daiichi Sankyo
Covington
Healthtrust
McKinsey
Farmers Insurance

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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