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Last Updated: March 28, 2024

Kombiglyze XR Drug Patent Profile


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When do Kombiglyze Xr patents expire, and what generic alternatives are available?

Kombiglyze Xr is a drug marketed by Astrazeneca Ab and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-seven patent family members in thirty-two 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

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Recent Clinical Trials for Kombiglyze XR

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

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

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 ⤷  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 200678-002 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 200678-001 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

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
European Patent Office 2995615 INHIBITEURS DE LA DIPEPTIDYL-PEPTIDASE IV COMPRENANT UNE PYRROLIDINE ET UN CYCLOPROPYLE FUSIONNÉS ET LEUR UTILISATION PHARMACEUTIQUE (CYCLOPROPYL-FUSED PYRROLIDINE-BASED INHIBITORS OF DIPEPTIDYL PEPTIDASE IV AND THEIR PHARMACEUTICAL USE) ⤷  Try a Trial
Taiwan 200624420 ⤷  Try a Trial
Portugal 1261586 ⤷  Try a Trial
Japan 2014040486 INHIBITORS OF DIPEPTIDYL PEPTIDASE IV HAVING CYCLOPROPYL-FUSED PYRROLIDINE BACKBONE AND METHOD ⤷  Try a Trial
Spain 2582646 ⤷  Try a Trial
Brazil PI0510419 formulação e método de comprimido revestido ⤷  Try a Trial
Denmark 1261586 ⤷  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
1261586 12C0028 France ⤷  Try a Trial PRODUCT NAME: ASSOCIATION COMPRENANT LA SAXAGLIPTINE OU UN DE SES SELS ET LA METFORMINE OU UN DE SES SELS, Y COMPRIS L'ASSOCIATION CHLORHYDRATE DE SAXAGLIPTINE ET CHLORHYDRATE DE METFORMINE; REGISTRATION NO/DATE: EU/1/11/731/001 20111124
1261586 C01261586/01 Switzerland ⤷  Try a Trial FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
1532149 132013902118390 Italy ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1261586 CA 2012 00014 Denmark ⤷  Try a Trial
1261586 C300436 Netherlands ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTINE, ALSMEDE; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
2498758 132020000000034 Italy ⤷  Try a Trial PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
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.