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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Healthtrust
QuintilesIMS
Deloitte
Argus Health
Merck
Fuji
UBS
Fish and Richardson

Generated: April 22, 2018

DrugPatentWatch Database Preview

AVANDAMET Drug Profile

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

Avandamet is a drug marketed by Sb Pharmco and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twelve patent family members in forty-six countries.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-eight drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
Summary for AVANDAMET
International Patents:112
US Patents:2
Applicants:1
NDAs:1
Bulk Api Vendors: 93
Clinical Trials: 14
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AVANDAMET at DailyMed
Drug patent expirations by year for AVANDAMET

US Patents and Regulatory Information for AVANDAMET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-005 Aug 25, 2003 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 AVANDAMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-005 Aug 25, 2003 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 ➤ Sign Up ➤ Sign Up
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-004 Aug 25, 2003 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for AVANDAMET
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mg ➤ Subscribe 2004-10-22

Supplementary Protection Certificates for AVANDAMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2012 Austria ➤ Sign Up PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
2013 00001 Denmark ➤ Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
2008013,C1412357 Lithuania ➤ Sign Up PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
2014000071 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
UBS
Daiichi Sankyo
Dow
Cerilliant
Argus Health
Federal Trade Commission
Fish and Richardson
US Army

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