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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Fuji
Healthtrust
Baxter
Boehringer Ingelheim
Chinese Patent Office
Merck
Cantor Fitzgerald
Harvard Business School
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Generated: September 22, 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 five patent family members in forty-nine countries.

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

Summary for Generic Name: metformin hydrochloride; rosiglitazone maleate

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list48
Suppliers / Packagers: see list1
Clinical Trials: see list4,286
Drug Prices:see low prices
DailyMed Link:metformin hydrochloride; rosiglitazone maleate at DailyMed

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

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
5,521,201 Method for treatment of atherosclerosis► Subscribe
5,260,445 2,4-thiazolidinediones► Subscribe
5,232,925 Compounds► Subscribe
6,686,475 Compounds► Subscribe
5,194,443 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
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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
Argentina057970► Subscribe
Japan2614497► Subscribe
Canada1339902► Subscribe
South Korea20030019300► Subscribe
JapanH09183772► Subscribe
Slovakia286985► Subscribe
African Regional IP Organization (ARIPO)1389► Subscribe
Slovenia1231918► Subscribe
Yugoslavia38802► Subscribe
Germany60019329► 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
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
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1261586/02Switzerland► SubscribePRODUCT NAME: SAXAGLIPTIN UND METFORMIN; NAT. REGISTRATION NO/DATE: SWISSMEDIC 62040 20120329
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:
/2000Austria► SubscribePRODUCT NAME: ROSIGLITAZONE; NAT. REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711; FIRST REGISTRATION: LI 55176 19990929
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
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
2014000070Germany► SubscribePRODUCT 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
90013-0Sweden► SubscribePRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
Merck
Colorcon
Mallinckrodt
Argus Health
Express Scripts
US Army
Cantor Fitzgerald
Cipla

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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