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Rosiglitazone maleate - Generic Drug Details

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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.

This ingredient 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:2
Applicants:2
NDAs:2
Drug Master File Entries: see list12
Suppliers / Packaging: see list3
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices

Tentative approvals for ROSIGLITAZONE MALEATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL2MG
<disabled><disabled>TABLET; ORAL4MG
<disabled><disabled>TABLET; ORAL8MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 1999RXNo6,288,095*PED► subscribeY► subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 1999RXNo6,288,095*PED► subscribeY► subscribe
Teva
ROSIGLITAZONE MALEATE
rosiglitazone maleate
TABLET;ORAL076747-002Jan 25, 2013RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: rosiglitazone maleate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-003May 25, 19995,741,803*PED► subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-002May 25, 19995,002,953*PED► subscribe
Sb Pharmco
AVANDIA
rosiglitazone maleate
TABLET;ORAL021071-004May 25, 19995,002,953*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
5,194,443 Compounds► subscribe
5,002,953 Novel compounds► subscribe
6,686,475 Compounds► 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
South Korea0164207► subscribe
Portugal88410► subscribe
Germany3856378► 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
01C/004Belgium► subscribePRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
/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.
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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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