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Last Updated: March 28, 2024

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JENTADUETO XR Drug Patent Profile


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Which patents cover Jentadueto Xr, and what generic alternatives are available?

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

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

The generic ingredient in JENTADUETO XR 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 XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JENTADUETO XR Extended-release Tablets linagliptin; metformin hydrochloride 2.5 mg/1000 mg 5 mg/1000 mg 208026 1 2018-03-28

US Patents and Regulatory Information for JENTADUETO XR

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

Patents protecting JENTADUETO XR

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

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

Uses of DPP IV inhibitors
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

Pharmaceutical composition and uses thereof
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting JENTADUETO XR

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 208026-001 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 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 208026-001 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 XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for JENTADUETO XR

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 XR

When does loss-of-exclusivity occur for JENTADUETO XR?

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

Argentina

Patent: 0269
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 13229538
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 66421
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 14002325
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4220049
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1400986
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 22544
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 04953
Estimated Expiration: ⤷  Try a Trial

India

Patent: 01DEN2014
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 15509519
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 14010560
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 014501984
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201405509U
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 140131950
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 1400144
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 XR around the world.

Country Patent Number Title Estimated Expiration
Taiwan 200944209 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions ⤷  Try a Trial
Japan 2012092136 USE OF DIPEPTIDYL PEPTIDASE IV EFFECTOR FOR LOWERING BLOOD GLUCOSE LEVEL IN MAMMAL ⤷  Try a Trial
Spain 2458106 ⤷  Try a Trial
China 102432593 Process for the preparation of chiral 8-(3-aminopiperidin-1yl)-xanthines ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JENTADUETO XR

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
>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.