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Serving leading biopharmaceutical companies globally:

UBS
Dow
Federal Trade Commission
US Army
Cerilliant
Deloitte
QuintilesIMS
Colorcon
Fish and Richardson
Express Scripts

Generated: October 24, 2017

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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eight patent family members in forty-nine countries and thirty-four supplementary protection certificates in twelve countries.

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

Summary for Tradename: AVANDAMET

US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list120
Clinical Trials: see list14
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:AVANDAMET at DailyMed
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;ORAL021410-004Aug 25, 2003DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-005Aug 25, 2003DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 2003DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-005Aug 25, 2003DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: AVANDAMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 2003► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-005Aug 25, 2003► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for AVANDAMET

Drugname Dosage Strength RLD Submissiondate
rosiglitazone maleate and metformin hydrochlorideTablets1 mg/ 500 mg, 2 mg/ 500mg, 4 mg/ 500 mg, 2 mg/ 1000 mg and 4 mg/ 1000 mgAvandamet10/22/2004

Non-Orange Book Patents for Tradename: AVANDAMET

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
5,756,525 Compounds for treating eating disorders► Subscribe
5,521,201 Method for treatment of atherosclerosis► Subscribe
5,232,925 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
5,260,445 2,4-thiazolidinediones► 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 Tradename: AVANDAMET

Country Document Number Estimated Expiration
China1736377► Subscribe
MontenegroP34008► Subscribe
Norway329926► Subscribe
Bulgaria65616► Subscribe
EcuadorSP003769► Subscribe
Eurasian Patent Organization200200571► Subscribe
Czech Republic9103916► Subscribe
Austria292466► Subscribe
United Kingdom0013240► Subscribe
South Korea0169463► 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: AVANDAMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
00524Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
9 5017-2014Slovakia► SubscribePRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
C0006France► SubscribePRODUCT 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
2013 00001Denmark► SubscribePRODUCT 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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Accenture
Daiichi Sankyo
Harvard Business School
Moodys
Julphar
McKinsey
McKesson
Johnson and Johnson
Teva

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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