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Last Updated: March 3, 2024

KOMBIGLYZE XR Drug Patent Profile


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Which patents cover Kombiglyze Xr, and what generic 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 twenty-seven patent family members in forty-one countries.

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

Drug patent expirations by year for KOMBIGLYZE XR
Drug Prices for KOMBIGLYZE XR

See drug prices for KOMBIGLYZE XR

Recent Clinical Trials for KOMBIGLYZE XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The First Affiliated Hospital of Guangzhou Medical UniversityPhase 3
The University of Hong KongPhase 3
Karolinska InstitutetPhase 3

See all KOMBIGLYZE XR clinical trials

Pharmacology for KOMBIGLYZE XR
Paragraph IV (Patent) Challenges for KOMBIGLYZE XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
KOMBIGLYZE XR Extended-release Tablets metformin hydrochloride; saxagliptin hydrochloride 5 mg/500 mg 2.5 mg/1000 mg 5 mg/1000 mg 200678 3 2013-07-31

US Patents and Regulatory Information for KOMBIGLYZE XR

KOMBIGLYZE XR is protected by four US patents.

Patents protecting KOMBIGLYZE XR

Coated tablet formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Coated tablet formulation and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN IN COMBINATION WITH METFORMIN

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENTWITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE

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;ORAL 200678-003 Nov 5, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for KOMBIGLYZE XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for KOMBIGLYZE XR

When does loss-of-exclusivity occur for KOMBIGLYZE XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 9062
Estimated Expiration: ⤷  Try a Trial

Patent: 9567
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05249467
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510419
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 68391
Estimated Expiration: ⤷  Try a Trial

China

Patent: 88891
Estimated Expiration: ⤷  Try a Trial

Patent: 2895208
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0160880
Estimated Expiration: ⤷  Try a Trial

Patent: 0161210
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 17813
Estimated Expiration: ⤷  Try a Trial

Patent: 18162
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Patent: 78369
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0094639
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 94951
Estimated Expiration: ⤷  Try a Trial

Patent: 55399
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 29039
Estimated Expiration: ⤷  Try a Trial

Patent: 29446
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9454
Estimated Expiration: ⤷  Try a Trial

Patent: 8117
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 01727
Estimated Expiration: ⤷  Try a Trial

Patent: 08501025
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 7639
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06013711
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 516
Estimated Expiration: ⤷  Try a Trial

Patent: 643
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1591
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3907
Estimated Expiration: ⤷  Try a Trial

Patent: 065870
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060425
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 72894
Estimated Expiration: ⤷  Try a Trial

Patent: 06146971
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 929
Estimated Expiration: ⤷  Try a Trial

Patent: 174
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 53406
Estimated Expiration: ⤷  Try a Trial

Patent: 98288
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609541
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1290925
Estimated Expiration: ⤷  Try a Trial

Patent: 070027560
Estimated Expiration: ⤷  Try a Trial

Patent: 120064141
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 82646
Estimated Expiration: ⤷  Try a Trial

Patent: 93582
Estimated Expiration: ⤷  Try a Trial

Patent: 54573
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 54569
Estimated Expiration: ⤷  Try a Trial

Patent: 15635
Estimated Expiration: ⤷  Try a Trial

Patent: 0609002
Estimated Expiration: ⤷  Try a Trial

Patent: 1204414
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 168
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering KOMBIGLYZE XR around the world.

Country Patent Number Title Estimated Expiration
Georgia, Republic of P20094639 COATED TABLET FORMULATION AND METHOD ⤷  Try a Trial
Portugal 1753406 ⤷  Try a Trial
Montenegro 02516 FORMULACIJA I METOD OBLOŽENE TABLETE (COATED TABLET FORMULATION AND METHOD) ⤷  Try a Trial
Ukraine 88168 ПРЕПАРАТ В ВИДЕ ТАБЛЕТКИ САКСАГЛИПТИНА С ПОКРЫТИЕМ И СПОСОБ ЕГО ИЗГОТОВЛЕНИЯ;ПРЕПАРАТ У ВИГЛЯДІ ТАБЛЕТКИ САКСАГЛІПТИНУ З ПОКРИТТЯМ І СПОСІБ ЙОГО ВИГОТОВЛЕННЯ (COATED TABLET FORMULATION COMPRISING SAXAGLIPITIN AND METHOD FOR FORMING THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 SPC/GB08/040 United Kingdom ⤷  Try a Trial PRODUCT 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
2498758 LUC00152 Luxembourg ⤷  Try a Trial PRODUCT NAME: METFORMINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; SAXAGLIPTINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; DAPAGLIFLOZINE OU UN SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/19/1401 20191113
1506211 CR 2014 00037 Denmark ⤷  Try a Trial PRODUCT 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
1261586 SPC005/2010 Ireland ⤷  Try a Trial SPC005/2010: 20100702, EXPIRES: 20240930
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.