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KOMBIGLYZE XR Drug Profile

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Which patents cover Kombiglyze Xr, and what substitute generic drugs 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 two 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. Two suppliers are 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 list2
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 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, 2010RXYesNoRE44186► SubscribeYY ► Subscribe
Astrazeneca Ab
KOMBIGLYZE XR
metformin hydrochloride; saxagliptin hydrochloride
TABLET, EXTENDED RELEASE;ORAL200678-001Nov 5, 2010RXYesNoRE44186► SubscribeYY ► 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;ORAL200678-002Nov 5, 2010RXYesYes► 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
Hungary230380► Subscribe
Denmark1261586► Subscribe
Hungary0302792► Subscribe
Luxembourg91985► Subscribe
Norway2012009► 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
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
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
985Luxembourg► Subscribe91985, EXPIRES: 20260305
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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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