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Serving leading biopharmaceutical companies globally:

Cipla
Baxter
Mallinckrodt
Argus Health
AstraZeneca
Daiichi Sankyo
Teva
Deloitte
US Department of Justice
McKesson

Generated: December 15, 2017

DrugPatentWatch Database Preview

METROGEL Drug Profile

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Which patents cover Metrogel, and what generic alternatives are available?

Metrogel is a drug marketed by Galderma Labs Lp and Medicis and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-eight patent family members in nineteen countries and one supplementary protection certificate in one country.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Eighty-four suppliers are listed for this compound. Additional details are available on the metronidazole profile page.
Drug patent expirations by year for METROGEL

Pharmacology for METROGEL

Medical Subject Heading (MeSH) Categories for METROGEL

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL019737-001Nov 22, 1988ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
MedicisMETROGEL-VAGINALmetronidazoleGEL;VAGINAL020208-001Aug 17, 1992ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL021789-001Jun 30, 2005ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Galderma Labs LpMETROGELmetronidazoleGEL;TOPICAL021789-001Jun 30, 2005ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for METROGEL

Drugname Dosage Strength RLD Submissiondate
metronidazoleTopical Gel1%Metrogel10/21/2008
metronidazoleVaginal Gel0.75%MetroGel-Vaginal9/2/2004

International Patent Family for Tradename: METROGEL

Country Document Number Estimated Expiration
European Patent Office2241320► Subscribe
European Patent Office1467744► Subscribe
Hong Kong1071514► Subscribe
Brazil0215331► Subscribe
South Korea20040075911► Subscribe
Russian Federation2413501► Subscribe
BrazilPI0215331► Subscribe
Denmark1467744► Subscribe
Canada2470492► Subscribe
Argentina037755► 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: METROGEL

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:

Chubb
Mallinckrodt
Federal Trade Commission
McKinsey
Covington
Cantor Fitzgerald
QuintilesIMS
Teva
Express Scripts
Citi

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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