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Serving leading biopharmaceutical companies globally:

Covington
Accenture
Chinese Patent Office
Medtronic
UBS
US Department of Justice
McKinsey
Cipla
Fuji
Novartis

Generated: January 18, 2018

DrugPatentWatch Database Preview

AVANDIA Drug Profile

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When do Avandia patents expire, and what generic alternatives 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. Additional details are available on the rosiglitazone maleate profile page.

US Patents and Regulatory Information for AVANDIA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for AVANDIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-004 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-002 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Subscribe ➤ Subscribe
Sb Pharmco AVANDIA rosiglitazone maleate TABLET;ORAL 021071-003 May 25, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
5,521,201 Method for treatment of atherosclerosis ➤ Subscribe
5,002,953 Novel compounds ➤ Subscribe
6,686,475 Compounds ➤ Subscribe
5,194,443 Compounds ➤ Subscribe
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised ➤ Subscribe
5,260,445 2,4-thiazolidinediones ➤ Subscribe
5,232,925 Compounds ➤ Subscribe
5,756,525 Compounds for treating eating disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for AVANDIA

Supplementary Protection Certificates for AVANDIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/003 United Kingdom ➤ Subscribe PRODUCT 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
/2000 Austria ➤ Subscribe PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
C0002 France ➤ Subscribe PRODUCT 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
/2000 Austria ➤ Subscribe PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
00034 Netherlands ➤ Subscribe PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
00035 Netherlands ➤ Subscribe PRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
01C/004 Belgium ➤ Subscribe PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
C/GB01/002 United Kingdom ➤ Subscribe PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Julphar
Cipla
Deloitte
US Department of Justice
Merck
Boehringer Ingelheim
Chubb
Novartis

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