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Serving leading biopharmaceutical companies globally:

Farmers Insurance
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Daiichi Sankyo
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Federal Trade Commission
McKinsey
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Generated: November 25, 2017

DrugPatentWatch Database Preview

Metformin hydrochloride; rosiglitazone maleate - Generic Drug Details

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What are the generic drug sources for metformin hydrochloride; rosiglitazone maleate and what is the scope of metformin hydrochloride; rosiglitazone maleate patent protection?

Metformin hydrochloride; rosiglitazone maleate
is the generic ingredient in two branded drugs marketed by Sb Pharmco and Teva, and is included in two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Metformin hydrochloride; rosiglitazone maleate has one hundred and seven patent family members in forty-nine countries and thirty-four supplementary protection certificates in twelve countries.

There are forty-eight drug master file entries for metformin hydrochloride; rosiglitazone maleate. One supplier is listed for this compound.

Summary for metformin hydrochloride; rosiglitazone maleate

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;ORAL021410-003Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-003May 7, 2014RXNoNo► Subscribe► Subscribe► Subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-001May 7, 2014RXNoNo► Subscribe► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-004Aug 25, 2003DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-005May 19, 2017RXNoNo► Subscribe► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-002Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: metformin hydrochloride; rosiglitazone maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-003Oct 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;ORAL021410-003Oct 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;ORAL021410-004Aug 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;ORAL021410-005Aug 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;ORAL021410-003Oct 10, 2002► Subscribe► Subscribe
Sb Pharmco
AVANDAMET
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL021410-001Oct 10, 2002► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: metformin hydrochloride; 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
5,002,953 Novel compounds► Subscribe
5,260,445 2,4-thiazolidinediones► Subscribe
5,521,201 Method for treatment of atherosclerosis► Subscribe
6,686,475 Compounds► Subscribe
5,756,525 Compounds for treating eating disorders► Subscribe
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised► Subscribe
5,232,925 Compounds► Subscribe
5,194,443 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: metformin hydrochloride; rosiglitazone maleate

Country Document Number Estimated Expiration
China1736377► Subscribe
Argentina030920► Subscribe
Australia2004226955► Subscribe
South Africa200203865► Subscribe
Japan5282130► Subscribe
JapanH10194970► Subscribe
Poland355331► Subscribe
United Kingdom8802454► Subscribe
United Kingdom9927119► Subscribe
Australia1404001► 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: METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131/02Switzerland► SubscribePRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
00677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
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
00034Netherlands► SubscribePRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
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Serving leading biopharmaceutical companies globally:

Dow
Queensland Health
Cantor Fitzgerald
Baxter
Express Scripts
Fuji
Novartis
Merck
US Department of Justice
UBS

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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