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Last Updated: March 28, 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
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
>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
Uruguay 27946 8-(3-AMINO-PIPERIDIN-1 IL)- XANTINAS, SU PREPARACIÓN Y SU UTILIZACIÓN COMO MEDICAMENTOS ⤷  Try a Trial
Israel 182923 שיטה לייצור 8-(3-אמינו-פיפרידין-1-איל)-קסנטינים כירליים (Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines) ⤷  Try a Trial
Argentina 060757 USOS DE INHIBIDORES DE DPP IV ⤷  Try a Trial
Denmark 2287164 ⤷  Try a Trial
Japan 5734564 ⤷  Try a Trial
Japan 2011516456 ⤷  Try a Trial
Japan 2010248253 METHOD FOR REGULATING GLUCOSE METABOLISM AND REAGENT RELATED THERETO ⤷  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
1084705 CA 2014 00062 Denmark ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1084705 C300709 Netherlands ⤷  Try a Trial PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705 CR 2014 00062 Denmark ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1084705 CA 2014 00063 Denmark ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
0896538 300308 Netherlands ⤷  Try a Trial 300308, 20170424, EXPIRES: 20220423
1532149 C 2012 003 Romania ⤷  Try a Trial PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-IL)-7-BUT-2-INIL-3-METIL-1-(4-METILCHINAZOLIN-2-ILMETIL)3,7-DIHIDROPURIN-2,6-DIONA, ENANTIOMERII SI SARURILE LOR IN SPECIAL LINAGLIPTIN - LINAGLIPTIN, ENANTIOMERIISI SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/707/001 - RO EU/1/11/707/011; DATE OF NATIONAL AUTHORISATION: 20110824; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/11/707/001 - EU/1/11/707/011; DATE OF FIRST AUTHORISATION IN EEA: 20110824
1084705 C300707 Netherlands ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
>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.