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Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details

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Metformin hydrochloride; rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and three patent family members in forty-eight countries.

There are forty-seven drug master file entries for metformin hydrochloride; rosiglitazone maleate. One supplier is listed for this compound.

Summary for Generic Name: metformin hydrochloride; rosiglitazone maleate

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list47
Suppliers / Packagers: see list1
Clinical Trials: see list1,772
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:metformin hydrochloride; rosiglitazone maleate at DailyMed

Pharmacology for Ingredient: metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo8,236,345► subscribeY ► subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-001May 7, 2014RXNoNo► subscribe► subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-002May 7, 2014RXNoNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 20025,002,953*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 20025,741,803*PED► subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 20035,002,953*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: metformin hydrochloride; rosiglitazone maleate

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
6,686,475 Compounds► subscribe
5,521,201 Method for treatment of atherosclerosis► subscribe
5,260,445 2,4-thiazolidinediones► 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 Ingredient: metformin hydrochloride; rosiglitazone maleate

Country Document Number Estimated Expiration
Japan2837139► subscribe
Eurasian Patent Organization004878► subscribe
Poland355331► 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: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0677Netherlands► subscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
C/GB08/040United Kingdom► subscribePRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
/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
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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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