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Serving 500+ biopharmaceutical companies globally:

Healthtrust
Express Scripts
Cipla
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Fuji
Chubb
Medtronic
Cerilliant
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Teva

Generated: June 27, 2017

DrugPatentWatch Database Preview

KOMBIGLYZE XR Drug Profile

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Which patents cover Kombiglyze Xr, and what generic Kombiglyze Xr alternatives are available?

Kombiglyze Xr is a drug marketed by Astrazeneca Ab 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 thirty-eight countries.

The generic ingredient in KOMBIGLYZE XR is metformin hydrochloride; saxagliptin hydrochloride. There are forty-seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

Summary for Tradename: KOMBIGLYZE XR

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list3
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:KOMBIGLYZE XR at DailyMed

Pharmacology for Tradename: KOMBIGLYZE XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo9,339,472► SubscribeY ► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-002Nov 5, 2010RXYesYesRE44186► SubscribeYY ► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-003Nov 5, 2010RXYesNo► Subscribe► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo8,628,799► SubscribeY ► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNo► Subscribe► Subscribe
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Paragraph IV activity for: KOMBIGLYZE XR

Drugname Dosage Strength RLD Submissiondate
saxagliptin hydrochloride and metformin hydrochlorideExtended-release Tablets5 mg/500 mg, 2.5 mg/1000 mg, and 5 mg/1000 mgKombiglyze XR7/31/2013

Non-Orange Book Patents for Tradename: KOMBIGLYZE XR

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
7,951,400Coated tablet formulation and method► Subscribe
6,395,767 Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method► 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: KOMBIGLYZE XR

Country Document Number Estimated Expiration
Australia2005249467► Subscribe
Japan5953292► Subscribe
Spain2553573► Subscribe
Norway20065870► Subscribe
Japan2010077163► 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: KOMBIGLYZE XR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C/GB10/001United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF INCLUDING SAXAGLIPTIN HYDROCHLORIDE; REGISTERED: UK EU/1/09/545/001 20091001; UK EU/1/09/545/002 20091001; UK EU/1/09/545/003 20091001; UK EU/1/09/545/004 20091001; UK EU/1/09/545/005 20091001; UK EU/1/09/545/006 20091001; UK EU/1/09/545/007 20091001; UK EU/1/09/545/008 20091001; UK EU/1/09/545/009 20091001; UK EU/1/09/545/010 20091001
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
C/GB08/040United Kingdom► SubscribePRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
AstraZeneca
US Department of Justice
Cerilliant
Federal Trade Commission
Novartis
Daiichi Sankyo
Baxter
Julphar
Harvard Business School

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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