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Last Updated: January 15, 2021

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AVANDAMET Drug Profile

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When do Avandamet patents expire, and what generic alternatives are available?

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

This drug has sixty-eight patent family members in forty-four countries.

The generic ingredient in AVANDAMET is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Avandamet

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

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for AVANDAMET
Recent Clinical Trials for AVANDAMET

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

SponsorPhase
GlaxoSmithKlinePhase 1
M.D. Anderson Cancer CenterPhase 1
Susan G. Komen Breast Cancer FoundationPhase 1

See all AVANDAMET clinical trials

Paragraph IV (Patent) Challenges for AVANDAMET
Tradename Dosage Ingredient NDA Submissiondate
AVANDAMET TABLET;ORAL metformin hydrochloride; rosiglitazone maleate 021410 2004-10-22

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   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-002 Oct 10, 2002 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-005 Aug 25, 2003 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-001 Oct 10, 2002 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Sb Pharmco AVANDAMET metformin hydrochloride; rosiglitazone maleate TABLET;ORAL 021410-003 Oct 10, 2002 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 AVANDAMET

Supplementary Protection Certificates for AVANDAMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 SPC/GB08/040 United Kingdom   Start Trial PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
2498758 132020000000034 Italy   Start Trial PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
0861666 07C0006 France   Start Trial PRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
1174135 437 Finland   Start Trial
1261586 132012902044560 Italy   Start Trial PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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