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Last Updated: May 28, 2022

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. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Kombiglyze Xr

Kombiglyze Xr was eligible for patent challenges on July 31, 2013.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2025. This may change due to patent challenges or generic licensing.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

See drug prices for KOMBIGLYZE XR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for KOMBIGLYZE XR
Generic Entry Date for KOMBIGLYZE XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KOMBIGLYZE XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting KOMBIGLYZE XR

Coated tablet formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Coated tablet formulation and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Cyclopropyl-fused pyrrolidine-based inhibitors of dipeptidyl peptidase IV and method
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-003 Nov 5, 2010 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 200678-003 Nov 5, 2010 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-002 Nov 5, 2010 See Plans and Pricing See Plans and Pricing
Astrazeneca Ab KOMBIGLYZE XR metformin hydrochloride; saxagliptin hydrochloride TABLET, EXTENDED RELEASE;ORAL 200678-001 Nov 5, 2010 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Patent: 9567
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05249467
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510419
Estimated Expiration: See Plans and Pricing

Canada

Patent: 68391
Estimated Expiration: See Plans and Pricing

China

Patent: 88891
Estimated Expiration: See Plans and Pricing

Patent: 2895208
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160880
Estimated Expiration: See Plans and Pricing

Patent: 0161210
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17813
Estimated Expiration: See Plans and Pricing

Patent: 18162
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Patent: 78369
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0094639
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 94951
Estimated Expiration: See Plans and Pricing

Patent: 55399
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 29039
Estimated Expiration: See Plans and Pricing

Patent: 29446
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9454
Estimated Expiration: See Plans and Pricing

Patent: 8117
Estimated Expiration: See Plans and Pricing

Japan

Patent: 01727
Estimated Expiration: See Plans and Pricing

Patent: 08501025
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 98288
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7639
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06013711
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 516
Estimated Expiration: See Plans and Pricing

Patent: 643
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1591
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3907
Estimated Expiration: See Plans and Pricing

Patent: 065870
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060425
Estimated Expiration: See Plans and Pricing

Poland

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 72894
Estimated Expiration: See Plans and Pricing

Patent: 06146971
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 929
Estimated Expiration: See Plans and Pricing

Patent: 174
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 53406
Estimated Expiration: See Plans and Pricing

Patent: 98288
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0609541
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1290925
Estimated Expiration: See Plans and Pricing

Patent: 070027560
Estimated Expiration: See Plans and Pricing

Patent: 120064141
Estimated Expiration: See Plans and Pricing

Spain

Patent: 82646
Estimated Expiration: See Plans and Pricing

Patent: 93582
Estimated Expiration: See Plans and Pricing

Patent: 54573
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 54569
Estimated Expiration: See Plans and Pricing

Patent: 15635
Estimated Expiration: See Plans and Pricing

Patent: 0609002
Estimated Expiration: See Plans and Pricing

Patent: 1204414
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 168
Estimated Expiration: See Plans and Pricing

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
Uruguay 26613 INHIBIDORES A BASE DE PIRROLIDINA FUSIONADA CON CICLOPROPILO DE DIPEPTIDIL PEPTIDASA IV Y MÉTODO See Plans and Pricing
China 1988891 Coated tablet formulation and method See Plans and Pricing
European Patent Office 2298288 Formulation de comprime revêtu et procède correspondant (Coated tablet formulation and method) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for KOMBIGLYZE XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CA 2013 00001 Denmark See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1506211 CA 2014 00037 Denmark See Plans and Pricing 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 132012902044560 Italy See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Moodys
AstraZeneca
Medtronic
Johnson and Johnson

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.