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Last Updated: July 16, 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-two 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
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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 ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

DPP IV inhibitor formulations
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition, methods for treating and uses thereof
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Uses of DPP-IV inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Uses of DPP IV inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-001 Jan 30, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim GLYXAMBI empagliflozin; linagliptin TABLET;ORAL 206073-002 Jan 30, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
Estimated Expiration: ⤷  Sign Up

Patent: 7657
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 08288407
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0815331
Patent: composição farmacêutica compreendendo um derivado de benzeno glucopiranosila substituída
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 96558
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DERIVE DE BENZENE A SUBSTITUTION GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 08002427
Patent: Composicion farmaceutica que comprende 1-cloro-4-(b-d-glucopiranos-1-il)-2-[4-((s)-tetrahidrofurano-3-iloxi)bencil]-benceno combinado con 1-[(4-metilquinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(r)-aminopiperidin-1-il)xantina; y su uso para tratar diabetes mellitus tipo 2.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1784270
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Patent: 4288166
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Patent: 4353077
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51239
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO JUNTO CON UN INHIBIDOR DE DPP IV
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170022
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 18308
Estimated Expiration: ⤷  Sign Up

Patent: 17017
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 87879
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 109977
Patent: Composición farmacéutica que comprende un derivado de benceno sustituido con glucopiranosilo.
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 8608
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГЛЮКОПИРАНОЗИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ БЕНЗОЛА И ИНГИБИТОР DPP IV (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE AND DPP IV INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 1000321
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГЛЮКОПИРАНОЗИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ БЕНЗОЛА
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 87879
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE À SUBSTITUTION GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Patent: 98152
Patent: Composition pharmaceutique comprenant un dérivé de benzène substitué de glucopyranosyl (Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative)
Estimated Expiration: ⤷  Sign Up

Patent: 06156
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE SUBSTITUÉ PAR GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Patent: 39577
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE SUBSTITUÉ PAR GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 01721
Patent: 包含吡喃葡萄糖基-取代的苯衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Patent: 03351
Patent: 包含吡喃葡萄糖基-取代的苯衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 30158
Estimated Expiration: ⤷  Sign Up

Patent: 700020
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2886
Patent: תכשיר רוקחות המכיל תולדת בנזן המותמרת בגלוקופיראנוזיל, באופן בריירתי המכילה בנוסף מעכב iv dpp ושימוש בו לייצור תרופה המונעת, מאיטה, מעכבת או מטפלת באי סדר מטבולי (Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative, optionally further comprising a dpp iv inhibitor and use thereof in the manufacture of a medicament for preventing, slowing, delaying or treating a metabolic disorder)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 95914
Estimated Expiration: ⤷  Sign Up

Patent: 10535850
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 187879
Estimated Expiration: ⤷  Sign Up

Patent: 2017014
Estimated Expiration: ⤷  Sign Up

Patent: 87879
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 2037
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 10001696
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO. (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTE D BENZENE DERIVATIVE.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 573
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI GLUKOPIRANOZILOM SUPSTITUISANI DERIVAT BENZENA (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 612
Patent: COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE BENZENE SUBSTITUE PAR GLUCOPYRANOSYLE
Estimated Expiration: ⤷  Sign Up

Netherlands

Patent: 0872
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3242
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 17020
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 090938
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 87879
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 87879
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 205
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI GLUKOPIRANOZILOM SUPSTITUISANI DERIVAT BENZENA (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 87879
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 0909105
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1491554
Estimated Expiration: ⤷  Sign Up

Patent: 100049595
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 02748
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 72325
Estimated Expiration: ⤷  Sign Up

Patent: 0914030
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Patent: 1436798
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000073
Patent: COMPOSITON PHARMACEUTIQUE CONTENANT UN DERIVE DE BENZENE SUBSTITUE PAR GLUCOPYRANOSYLE
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 0384
Patent: ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ГЛЮКОПІРАНОЗИЛЗАМІЩЕНУ ПОХІДНУ БЕНЗОЛУ ТА ІНГІБІТОР DPP IV (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 296
Patent: COMPOSICION FARMACÉUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
Estimated Expiration: ⤷  Sign Up

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
Germany 102004054054 Verfahren zur Herstellung chiraler 8-(3-Amino-piperidin-1-yl)-xanthine ⤷  Sign Up
China 104095854 Uses of DPP-IV inhibitors ⤷  Sign Up
Colombia 6410286 COMPOSICIÓN FARMACÉUTICA QUE COMPRENDE UN INHIBIDOR DE SGLT2, UN INHIBIDOR DE DPP-IV Y, OPCIONALMENTE, UN AGENTE ANTIDIABÉTICO ADICIONAL, Y SUS USOS ⤷  Sign Up
South Korea 20050058375 8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS ⤷  Sign Up
Hungary S1100028 ⤷  Sign Up
Taiwan I374885 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GLYXAMBI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 2011/039 Ireland ⤷  Sign Up PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-Y1)-7-BUT-2INYL-3-METHYL-1-(4- METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2,6-DION THE ENATIOMERS AND SALTS THEROF-ESPECIALLY LINAGLIPTIN."LINAGLIPTIN=((R)-8-(3-AMINOPIPERIDIN-1-YL)- 7-BUT-2-INYL-3-METHYL-L-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6- DION") (IUPAC); REGISTRATION NO/DATE: EU/1/11/707/001-EU/1/11/707/011 20110824
1532149 1190035-4 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
1084705 CA 2014 00066 Denmark ⤷  Sign Up PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919
2187879 20/2017 Austria ⤷  Sign Up PRODUCT NAME: KOMBINATION VON EMPAGLIFLOZIN UND LINAGLIPTIN ODER PHARMAZEUTISCH VERTRETBARE SALZE; REGISTRATION NO/DATE: EU/1/16/1146 (MITTEILUNG) 20161115
1084705 CA 2014 00062 Denmark ⤷  Sign Up PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1084705 CR 2014 00064 Denmark ⤷  Sign Up PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
>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.