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Last Updated: March 27, 2023

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 thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has five hundred and fifty-nine 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 October 14, 2029. This may change due to patent challenges or generic licensing.

There have been eighteen 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 Generic Entry Opportunity 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 fourteen US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GLYXAMBI 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 GLYXAMBI

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

DPP IV inhibitor formulations
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (30 ML/MIN/1.73 M2

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN

Uses of DPP-IV inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN

Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Uses of DPP IV inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2

FDA Regulatory Exclusivity protecting GLYXAMBI

ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
Exclusivity Expiration: See Plans and Pricing

INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
Exclusivity Expiration: 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
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 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: See Plans and Pricing

Patent: 7657
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08288407
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0815331
Estimated Expiration: See Plans and Pricing

Canada

Patent: 96558
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002427
Estimated Expiration: See Plans and Pricing

China

Patent: 1784270
Estimated Expiration: See Plans and Pricing

Patent: 4288166
Estimated Expiration: See Plans and Pricing

Patent: 4353077
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51239
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170022
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18308
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87879
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 109977
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 8608
Estimated Expiration: See Plans and Pricing

Patent: 1000321
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87879
Estimated Expiration: See Plans and Pricing

Patent: 98152
Estimated Expiration: See Plans and Pricing

Patent: 06156
Estimated Expiration: See Plans and Pricing

Patent: 39577
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 01721
Estimated Expiration: See Plans and Pricing

Patent: 03351
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30158
Estimated Expiration: See Plans and Pricing

Patent: 700020
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2886
Estimated Expiration: See Plans and Pricing

Japan

Patent: 95914
Estimated Expiration: See Plans and Pricing

Patent: 10535850
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 187879
Estimated Expiration: See Plans and Pricing

Patent: 2017014
Estimated Expiration: See Plans and Pricing

Patent: 87879
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 2037
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10001696
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 573
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 612
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 0872
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3242
Estimated Expiration: See Plans and Pricing

Norway

Patent: 17020
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090938
Estimated Expiration: See Plans and Pricing

Poland

Patent: 87879
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87879
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 205
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87879
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0909105
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1491554
Estimated Expiration: See Plans and Pricing

Patent: 100049595
Estimated Expiration: See Plans and Pricing

Spain

Patent: 02748
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 72325
Estimated Expiration: See Plans and Pricing

Patent: 0914030
Estimated Expiration: See Plans and Pricing

Patent: 1436798
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000073
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0384
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 296
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 GLYXAMBI around the world.

Country Patent Number Title Estimated Expiration
South Korea 20160128446 DPP IV 억제제 제형 (DPP IV inhibitor formulations) See Plans and Pricing
Spain 2314743 See Plans and Pricing
Australia 2003253418 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS See Plans and Pricing
Canada 2649922 FORMULATIONS DE L'INHIBITEUR DE DPP IV (DPP IV INHIBITOR FORMULATIONS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLYXAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1730131 C01730131/04 Switzerland See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1532149 CR 2011 00030 Denmark See Plans and Pricing PRODUCT NAME: LINAGLIPTIN OG SALTE DERAF; NAT. REG. NO/DATE: EU/1/11/707/001-011 20110830; FIRST REG. NO/DATE: EU EU/1/11/707/001-0011 20110830
1532149 PA2011013,C1532149 Lithuania See Plans and Pricing PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082
1730131 122014000099 Germany See Plans and Pricing PRODUCT NAME: EMPAGLIFLOZIN UND DESSEN SALZE, INSBESONDERE EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140522
>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.