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Rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for rosiglitazone maleate?

Rosiglitazone maleate is the generic ingredient in two branded drugs marketed by Teva and Sb Pharmco, and is included in two NDAs. There are three 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.

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

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list12
Suppliers / Packagers: see list3
Bulk Api Vendors: see list38
Clinical Trials: see list111
Patent Applications: see list3,989
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL2MG
► Subscribe► SubscribeTABLET; ORAL4MG
► Subscribe► SubscribeTABLET; ORAL8MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-002Jan 25, 2013RXNoNo► Subscribe► 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, 1999RXYesNo7,358,366*PED► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-001Jan 25, 2013RXNoNo► Subscribe► Subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 1999RXYesYes7,358,366*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: rosiglitazone maleate

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;ORAL021071-004May 25, 19995,741,803*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;ORAL021071-002May 25, 19995,741,803*PED► Subscribe
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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
5,002,953 Novel compounds► Subscribe
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised► Subscribe
6,686,475 Compounds► Subscribe
5,194,443 Compounds► Subscribe
5,521,201 Method for treatment of atherosclerosis► 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
Hong Kong1011029► Subscribe
Denmark200001556► Subscribe
South Africa8806536► Subscribe
Luxembourg90711► Subscribe
Denmark175176► 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
00035Netherlands► SubscribePRODUCT: ROSIGLITAZONE,MALEAAT, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT.
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
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
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
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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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