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Last Updated: April 13, 2024

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GLYXAMBI Drug Patent Profile


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

Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and sixty-one patent family members in forty-seven countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

DrugPatentWatch® Generic Entry Outlook for Glyxambi

Glyxambi was eligible for patent challenges on May 2, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2030. This may change due to patent challenges or generic licensing.

There have been nineteen 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.

There are three tentative approvals for the generic drug (empagliflozin; linagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for GLYXAMBI
Drug Prices for GLYXAMBI

See drug prices for GLYXAMBI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GLYXAMBI
Generic Entry Date for GLYXAMBI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.

Paragraph IV (Patent) Challenges for GLYXAMBI
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GLYXAMBI Tablets empagliflozin; linagliptin 10 mg/5 mg and 25 mg/5 mg 206073 9 2018-08-01

US Patents and Regulatory Information for GLYXAMBI

GLYXAMBI is protected by thirteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GLYXAMBI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  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.

Patents protecting GLYXAMBI

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DPP IV inhibitor formulations
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Uses of DPP-IV inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Uses of DPP IV inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX 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 GLYXAMBI

EU/EMA Drug Approvals for GLYXAMBI

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Glyxambi empagliflozin, linagliptin EMEA/H/C/003833
Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.
Authorised no no no 2016-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for GLYXAMBI

When does loss-of-exclusivity occur for GLYXAMBI?

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

Argentina

Patent: 7970
Estimated Expiration: ⤷  Try a Trial

Patent: 7657
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 08288407
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0815331
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 96558
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 08002427
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1784270
Estimated Expiration: ⤷  Try a Trial

Patent: 4288166
Estimated Expiration: ⤷  Try a Trial

Patent: 4353077
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51239
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170022
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18308
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 109977
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 8608
Estimated Expiration: ⤷  Try a Trial

Patent: 1000321
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Patent: 98152
Estimated Expiration: ⤷  Try a Trial

Patent: 06156
Estimated Expiration: ⤷  Try a Trial

Patent: 39577
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 01721
Estimated Expiration: ⤷  Try a Trial

Patent: 03351
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 30158
Estimated Expiration: ⤷  Try a Trial

Patent: 700020
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2886
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 95914
Estimated Expiration: ⤷  Try a Trial

Patent: 10535850
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 187879
Estimated Expiration: ⤷  Try a Trial

Patent: 2017014
Estimated Expiration: ⤷  Try a Trial

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 2037
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 10001696
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 573
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 612
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 0872
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3242
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 17020
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 090938
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 205
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 87879
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0909105
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1491554
Estimated Expiration: ⤷  Try a Trial

Patent: 100049595
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 02748
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 72325
Estimated Expiration: ⤷  Try a Trial

Patent: 0914030
Estimated Expiration: ⤷  Try a Trial

Patent: 1436798
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000073
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 0384
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 296
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 GLYXAMBI around the world.

Country Patent Number Title Estimated Expiration
Japan 2018193408 DPP IVインヒビターの使用 (USES OF DPP IV INHIBITORS) ⤷  Try a Trial
China 102846619 Uses of DPP-IV inhibitors ⤷  Try a Trial
European Patent Office 2287164 Procédé pour la préparation des 8-(3-aminopiperidin-1-yl)-xanthines chirales (Process for the manufacture of chiral 8-(3-aminopiperidin-1-yl)-xanthines) ⤷  Try a Trial
Portugal 2187879 ⤷  Try a Trial
South Africa 200909105 Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative ⤷  Try a Trial
Japan 6987908 ⤷  Try a Trial
South Korea 101383610 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLYXAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/01 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014
1730131 C01730131/02 Switzerland ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1730131 C20140033 00134 Estonia ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOSIIN;REG NO/DATE: EU/1/14/930 27.05.2014
0896538 300308 Netherlands ⤷  Try a Trial 300308, 20170424, EXPIRES: 20220423
1730131 C300696 Netherlands ⤷  Try a Trial PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522
2187879 1790019-2 Sweden ⤷  Try a Trial PRODUCT NAME: COMBINATION OF EMPAGLIFLOZIN AND LINAGLIPTIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1146 20161115
2187879 17C1016 France ⤷  Try a Trial PRODUCT NAME: COMBINAISON D'EMPAGLIFLOZINE ET DE LINAGLIPTINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/16/1146 20161115
>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.