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METROGEL Drug Profile

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

This drug has twenty-six patent family members in nineteen countries.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Summary for Tradename: METROGEL

Patents:2
Applicants:2
NDAs:3
Suppliers / Packagers: see list5
Drug Prices: :see details

Pharmacology for Tradename: METROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 1988RXYes► subscribe► subscribe
Medicis
METROGEL-VAGINAL
metronidazole
GEL;VAGINAL020208-001Aug 17, 1992RXYes► subscribe► subscribe
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL021789-001Jun 30, 2005RXYes6,881,726► subscribeY ► subscribe
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Expired Patents for Tradename: METROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
METROGEL
metronidazole
GEL;TOPICAL019737-001Nov 22, 19884,837,378► subscribe
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Paragraph IV activity 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
Cyprus1111095► subscribe
Argentina037755► subscribe
Brazil0215331► 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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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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