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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson
US Department of Justice
Queensland Health
UBS
Fuji
Cantor Fitzgerald
Novartis
Healthtrust
Teva

Generated: October 19, 2017

DrugPatentWatch Database Preview

Rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources for rosiglitazone maleate and what is the scope of rosiglitazone maleate freedom to operate?

Rosiglitazone maleate
is the generic ingredient in two branded drugs marketed by Teva and Sb Pharmco, and is included in two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rosiglitazone maleate has forty patent family members in twenty-two countries and eight supplementary protection certificates in five countries.

There are twelve drug master file entries for rosiglitazone maleate. Three suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: rosiglitazone maleate

US Patents:2
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: see list12
Suppliers / Packagers: see list3
Bulk Api Vendors: see list38
Clinical Trials: see list392
Patent Applications: see list4,114
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rosiglitazone maleate at DailyMed

Tentative approvals for ROSIGLITAZONE MALEATE

Applicant Application No. Strength Dosage Form
u► Subscribe2MGTABLET; ORAL
u► Subscribe8MGTABLET; ORAL
u► Subscribe4MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-003Jan 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 1999ABRXYesYes► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-002Jan 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 1999ABRXYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 1999ABRXYesYes► Subscribe► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-001Jan 25, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: rosiglitazone maleate

Non-Orange Book Patents for Generic Ingredient: 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
5,521,201 Method for treatment of atherosclerosis► Subscribe
5,002,953 Novel compounds► Subscribe
6,686,475 Compounds► Subscribe
5,232,925 Compounds► Subscribe
5,260,445 2,4-thiazolidinediones► Subscribe
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised► Subscribe
5,194,443 Compounds► 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 Ingredient: rosiglitazone maleate

Country Document Number Estimated Expiration
United Kingdom8720825► Subscribe
JapanH09183771► Subscribe
European Patent Office0842925► Subscribe
Japan2614497► Subscribe
Australia611938► Subscribe
Netherlands300034► Subscribe
JapanH09183726► Subscribe
Portugal88410► Subscribe
Singapore59988► Subscribe
Ireland20000683► 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: ROSIGLITAZONE MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
/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
00035Netherlands► SubscribePRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
01C/004Belgium► SubscribePRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
00034Netherlands► SubscribePRODUCT 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
/2000Austria► SubscribePRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Merck
Moodys
Fish and Richardson
US Army
Cipla
Mallinckrodt
US Department of Justice
Covington
Medtronic
McKinsey

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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