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Last Updated: March 18, 2024

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JENTADUETO Drug Patent Profile


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

Jentadueto is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and thirty patent family members in forty-five countries.

The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

Paragraph IV (Patent) Challenges for JENTADUETO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JENTADUETO Tablets linagliptin; metformin hydrochloride 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg 201281 8 2015-05-04

US Patents and Regulatory Information for JENTADUETO

JENTADUETO is protected by eight US patents and two FDA Regulatory Exclusivities.

Patents protecting JENTADUETO

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
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

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting JENTADUETO

REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity 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
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 AB 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 JENTADUETO

EU/EMA Drug Approvals for JENTADUETO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Jentadueto linagliptin, metformin hydrochloride EMEA/H/C/002279
Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Authorised no no no 2012-07-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for JENTADUETO

When does loss-of-exclusivity occur for JENTADUETO?

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

Argentina

Patent: 1175
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 09232043
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0911273
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 20450
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 09000809
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1983073
Estimated Expiration: ⤷  Try a Trial

Patent: 3083672
Estimated Expiration: ⤷  Try a Trial

Patent: 6215190
Estimated Expiration: ⤷  Try a Trial

Patent: 3648422
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 51277
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 85410
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010489
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9395
Estimated Expiration: ⤷  Try a Trial

Patent: 8435
Estimated Expiration: ⤷  Try a Trial

Patent: 1001577
Estimated Expiration: ⤷  Try a Trial

Patent: 1300121
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 85410
Estimated Expiration: ⤷  Try a Trial

Patent: 53403
Estimated Expiration: ⤷  Try a Trial

Patent: 44374
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 49485
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 41649
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 88428
Estimated Expiration: ⤷  Try a Trial

Patent: 22068
Estimated Expiration: ⤷  Try a Trial

Patent: 11516456
Estimated Expiration: ⤷  Try a Trial

Patent: 13237707
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 1232
Estimated Expiration: ⤷  Try a Trial

Patent: 10010819
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 200
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7747
Estimated Expiration: ⤷  Try a Trial

Patent: 9580
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 091730
Estimated Expiration: ⤷  Try a Trial

Patent: 140960
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 85410
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1005664
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1611314
Estimated Expiration: ⤷  Try a Trial

Patent: 1775942
Estimated Expiration: ⤷  Try a Trial

Patent: 110005690
Estimated Expiration: ⤷  Try a Trial

Patent: 160042174
Estimated Expiration: ⤷  Try a Trial

Patent: 170056021
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 96124
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 27816
Estimated Expiration: ⤷  Try a Trial

Patent: 0946534
Estimated Expiration: ⤷  Try a Trial

Patent: 1509941
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000431
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1818886
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4136
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 747
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 JENTADUETO around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2351568 UTILISATIONS D'INHIBITEURS DE L'ENZYME DPP IV (USES OF DPP-IV INHIBITORS) ⤷  Try a Trial
South Korea 20050104428 ⤷  Try a Trial
South Africa 201005664 DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION ⤷  Try a Trial
Hong Kong 1109405 手性 -氨基-哌啶- -基 -黃嘌呤的製備方法 (METHOD FOR PRODUCING CHIRAL 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES 8-(3---1-)-) ⤷  Try a Trial
Japan 6995822 ⤷  Try a Trial
Mexico 2020009911 USOS DE INHIBIORES DE DPP IV. (USES OF DPP-IV INHIBITORS.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JENTADUETO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 SPC/GB12/006 United Kingdom ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830
0896538 CA 2007 00030 Denmark ⤷  Try a Trial
1532149 CR 2011 00030 Denmark ⤷  Try a Trial 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
0896538 08C0008 France ⤷  Try a Trial PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
1532149 118 5013-2011 Slovakia ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001 - EU/1/11/707/011 20110824
1084705 PA2014042 Lithuania ⤷  Try a Trial PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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