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AVANDIA Drug Profile

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Which patents cover Avandia, and what substitute generic drugs are available?

Avandia is a drug marketed by Sb Pharmco and is included in one NDA. There are two patents protecting this drug.

This drug has forty patent family members in twenty-two countries.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the rosiglitazone maleate profile page.

Summary for Tradename: AVANDIA

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list122
Clinical Trials: see list8
Patent Applications: see list10,986
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AVANDIA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 1999RXYesNo6,288,095*PED► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 1999RXYesNo7,358,366*PED► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 1999RXYesNo7,358,366*PED► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 1999RXYesNo6,288,095*PED► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 1999RXYesYes7,358,366*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: AVANDIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 19995,002,953*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,002,953*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,741,803*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 19995,002,953*PED► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 19995,741,803*PED► Subscribe
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Non-Orange Book Patents for Tradename: AVANDIA

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
5,002,953 Novel compounds► Subscribe
5,521,201 Method for treatment of atherosclerosis► Subscribe
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised► Subscribe
5,756,525 Compounds for treating eating disorders► 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: AVANDIA

Country Document Number Estimated Expiration
Spain2137915► Subscribe
South Korea0169463► Subscribe
European Patent Office0842925► Subscribe
Netherlands300034► Subscribe
Brazil1100841► 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: AVANDIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000Austria► SubscribePRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
C/GB01/003United Kingdom► SubscribePRODUCT NAME: N-(4-(2(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY)BENZYL)THIAZOLIDINE-2,4-DIONE MALEIC ACID, "ROSIGLITAZONE MALEATE", ITS TAUTOMERS AND PHARMACEUTICALLY ACCEPTABLE SOLVATES; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
C0002France► SubscribePRODUCT NAME: MALEATE DE ROSIGLITAZONE OU L UN DE SES ISOMERES OU UNE DE SES FORMES TAUTOMERES ET/OU UN DE SES SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/00/137/001 DU 20000711; REGISTRATION NO/DATE AT EEC: IKS Nø 55 176 DU 19990929
/2000Austria► SubscribePRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
C/GB01/002United Kingdom► SubscribePRODUCT NAME: 5-(4-(2-(N-METHYL-N-(2-PYRIDYL)AMINO)ETHOXY) BENZYL)-2,4-THIAZOLIDINEDIONE, "ROSIGLITAZONE" ITS TAUTOMERS, PHARMACEUTICALLY ACCEPTABLE SALTS, SUCH AS THE MALEATE, AND PHARMACEUTICALLY ACCEPTABLE SOLVATES.; REGISTERED: CH 55176 02 19990929; CH 55176 03 19990929; CH 55176 04 19990929; UK EU/1/00/137/001 20000711; UK EU/1/00/137/002 20000711; UK EU/1/00/137/003 20000711; UK EU/1/00/137/004 20000711; UK EU/1/00/137/005 20000711; UK EU/1/00/137/006 20000711; UK EU/1/00/137/007 20000711; UK EU/1/00/137/008 20000711; UK EU/1/00/137/009 20000711; UK EU/1/00/137/010 20000711; UK EU/1/00/137/011 20000711; UK EU/1/00/137/012 20000711
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