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Last Updated: August 19, 2022

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 twelve patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-seven 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 ten 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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS

DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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

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 A DIPEPTIDYL PEPTIDASE-IV INHIBITOR

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 A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA

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 METFORMIN

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

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

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

FDA Regulatory Exclusivity protecting JENTADUETO

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 JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-001 May 27, 2016 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim JENTADUETO XR linagliptin; metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 208026-002 May 27, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing 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 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: See Plans and Pricing

Australia

Patent: 09232043
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0911273
Estimated Expiration: See Plans and Pricing

Canada

Patent: 20450
Estimated Expiration: See Plans and Pricing

Chile

Patent: 09000809
Estimated Expiration: See Plans and Pricing

China

Patent: 1983073
Estimated Expiration: See Plans and Pricing

Patent: 3083672
Estimated Expiration: See Plans and Pricing

Patent: 6215190
Estimated Expiration: See Plans and Pricing

Patent: 3648422
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51277
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 85410
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010489
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9395
Estimated Expiration: See Plans and Pricing

Patent: 8435
Estimated Expiration: See Plans and Pricing

Patent: 1001577
Estimated Expiration: See Plans and Pricing

Patent: 1300121
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 85410
Estimated Expiration: See Plans and Pricing

Patent: 53403
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 49485
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 41649
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7497
Estimated Expiration: See Plans and Pricing

Patent: 5637
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88428
Estimated Expiration: See Plans and Pricing

Patent: 22068
Estimated Expiration: See Plans and Pricing

Patent: 11516456
Estimated Expiration: See Plans and Pricing

Patent: 13237707
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 1232
Estimated Expiration: See Plans and Pricing

Patent: 10010819
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 200
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7747
Estimated Expiration: See Plans and Pricing

Patent: 9580
Estimated Expiration: See Plans and Pricing

Peru

Patent: 091730
Estimated Expiration: See Plans and Pricing

Patent: 140960
Estimated Expiration: See Plans and Pricing

Poland

Patent: 85410
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1005664
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1611314
Estimated Expiration: See Plans and Pricing

Patent: 1775942
Estimated Expiration: See Plans and Pricing

Patent: 110005690
Estimated Expiration: See Plans and Pricing

Patent: 160042174
Estimated Expiration: See Plans and Pricing

Patent: 170056021
Estimated Expiration: See Plans and Pricing

Spain

Patent: 96124
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 27816
Estimated Expiration: See Plans and Pricing

Patent: 0946534
Estimated Expiration: See Plans and Pricing

Patent: 1509941
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000431
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1818886
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4136
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 747
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 JENTADUETO around the world.

Country Patent Number Title Estimated Expiration
Turkey 201908974 See Plans and Pricing
Malaysia 137619 8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PREPARATION THEREOF AND THEIR USE AS PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
New Zealand 564768 8-[3-amino-piperidin-1-yl]-xanthines, the production thereof and the use of the same as medicaments See Plans and Pricing
Japan 6139004 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JENTADUETO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 CR 2014 00062 Denmark See Plans and Pricing PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005
1532149 8/2012 Austria See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION UND DESSEN SALZE, INSBES. LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 (MITTEILUNG) 20110830
1532149 2011/039 Ireland See Plans and Pricing 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 2011C/038 Belgium See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
McKinsey
Medtronic
Johnson and Johnson
Moodys

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.