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Last Updated: August 6, 2020

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AVANDIA Drug Profile

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Which patents cover Avandia, and when can generic versions of Avandia launch?

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

This drug has forty-five patent family members in thirty-six countries.

The generic ingredient in AVANDIA is rosiglitazone maleate. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rosiglitazone maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Avandia

Avandia was eligible for patent challenges on May 25, 2003.

There are six tentative approvals for the generic drug (rosiglitazone maleate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for AVANDIA
Drug Prices for AVANDIA

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Recent Clinical Trials for AVANDIA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Dan ZandbergPhase 2
National University, SingaporePhase 4
Agency for Science, Technology and ResearchPhase 4

See all AVANDIA clinical trials

Paragraph IV (Patent) Challenges for AVANDIA
Tradename Dosage Ingredient NDA Submissiondate
AVANDIA TABLET;ORAL rosiglitazone maleate 021071

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

Expired US Patents for AVANDIA

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

Supplementary Protection Certificates for AVANDIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0306228 38/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
0658161 SPC001/2001 Ireland   Start Trial SPC001/2001: 20050808, EXPIRES: 20140928
0306228 2001C/004 Belgium   Start Trial PRODUCT NAME: ROSIGLITAZONE; REGISTRATION NO/DATE: EU/1/00/137/001 20000717
0658161 01C0002 France   Start Trial 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
0658161 39/2000 Austria   Start Trial PRODUCT NAME: ROSIGLITAZONE MALEAT; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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