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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Dow
Merck
Chubb
McKesson
Baxter
Accenture
Covington
AstraZeneca
Moodys

Generated: August 20, 2017

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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 freedom to operate?

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 list4,256
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;ORAL021410-002Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► Subscribe
Teva
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
metformin hydrochloride; rosiglitazone maleate
TABLET;ORAL077337-002May 7, 2014RXNoNo► Subscribe► Subscribe► 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;ORAL021410-003Oct 10, 2002DISCNYesNo► Subscribe► SubscribeY► 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
5,646,169 Compounds for treating eating disorders in which blood glucose levels are raised► Subscribe
5,002,953 Novel compounds► Subscribe
5,756,525 Compounds for treating eating disorders► Subscribe
5,232,925 Compounds► Subscribe
6,686,475 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
China1414852► Subscribe
Japan4865975► Subscribe
South Korea100760063► Subscribe
South Africa8806536► Subscribe
Japan2837139► 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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
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
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Harvard Business School
Colorcon
Merck
Queensland Health
Dow
Baxter
Fuji
Moodys
Daiichi Sankyo

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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