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Serving 500+ biopharmaceutical companies globally:

McKinsey
AstraZeneca
McKesson
Federal Trade Commission
Accenture
Cantor Fitzgerald
Fuji
US Department of Justice
Healthtrust
Dow

Generated: August 17, 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 five patent family members in forty-nine 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

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
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Expired Patents for Tradename: AVANDAMET

Paragraph IV activity 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
5,646,169 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 Tradename: AVANDAMET

Country Document Number Estimated Expiration
Slovakia6792002► Subscribe
European Patent Office0842925► Subscribe
MexicoPA02005005► Subscribe
Czech Republic9103916► Subscribe
China1222290► 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
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 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:
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
/2012Austria► SubscribePRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cipla
Baxter
Chubb
Chinese Patent Office
UBS
Boehringer Ingelheim
Colorcon
Novartis
Citi
Queensland Health

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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