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AVANDAMET Drug Profile

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Avandamet is a drug marketed by Sb Pharmco and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-four patent family members in fifty countries.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

Summary for Tradename: AVANDAMET

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 2003DISCNNo8,236,345► subscribeY ► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002DISCNNo6,288,095*PED► subscribeY► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNNo8,236,345► subscribeY ► subscribe
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Expired Patents for Tradename: AVANDAMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 20025,002,953*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-005Aug 25, 20035,002,953*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 20025,002,953*PED► subscribe
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Paragraph IV activity for: AVANDAMET

Drugname Dosage Strength RLD Submissiondate
rosiglitazone maleate and metformin hydrochlorideTablets1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mgAvandamet10/22/2004

Non-Orange Book Patents for Tradename: AVANDAMET

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,288,090 Pharmaceutical composition► subscribe
6,225,326 Pharmaceutical composition► subscribe
5,232,925 Compounds► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AVANDAMET

Country Document Number Estimated Expiration
Greece3031873► subscribe
Australia2008207375► subscribe
TaiwanI238064► 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: AVANDAMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2008Austria► subscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
2014 00037Denmark► subscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
00569Netherlands► subscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
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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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