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Last Updated: November 7, 2024

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JENTADUETO Drug Patent Profile


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

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

This drug has three hundred and seventy-three 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.

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Drug patent expirations by year for JENTADUETO
Drug Prices for JENTADUETO

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Recent Clinical Trials for JENTADUETO

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SponsorPhase
Boehringer IngelheimPhase 1

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Pharmacology for JENTADUETO
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 nine 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
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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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Patent Number: ⤷  Sign Up
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Patented Use: LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN

8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
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Patent Expiration: ⤷  Sign Up

Uses of DPP-IV inhibitors
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Treatment for diabetes in patients with inadequate glycemic control despite metformin therapy comprising a DPP-IV inhibitor
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Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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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: ⤷  Sign Up

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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-001 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-002 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim JENTADUETO linagliptin; metformin hydrochloride TABLET;ORAL 201281-003 Jan 30, 2012 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE LA DIPEPTIDIL-PEPTIDASA-4 (DPP4) Y UN FARMACO ACOMPANANTE
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09232043
Patent: DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0911273
Patent: inibidor de dpp-iv combinado com outro agente antidiabético, comprimidos que compreendem tais formulações, seu uso e processo para sua preparação
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 20450
Patent: NOUVELLES FORMULATIONS, COMPRIMES COMPRENANT DE TELLES FORMULATIONS, LEUR UTILISATION ET LEUR PROCEDE DE PREPARATION (NEW FORMULATIONS, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 09000809
Patent: Composicion farmaceutica que comprende un inhibidor de la dpp4 1-[(4-metil-quinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(r)-amino-piperidin-1-il)-xantina y metformina o sus sales, junto a l-arginina para estabilizar al inhibidor de dpp4; procedimiento de preparacion de dicha composicion.
Estimated Expiration: ⤷  Sign Up

China

Patent: 1983073
Patent: Dpp-iv inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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Patent: 3083672
Patent: DPP-IV inhibitor combined with further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Estimated Expiration: ⤷  Sign Up

Patent: 6215190
Patent: 与其它抗糖尿病药组合的DPP‑IV抑制剂、包含此类制剂的片剂,和其用途和制备方法 (Dpp-iv inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation)
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Patent: 3648422
Patent: 与其它抗糖尿病药组合的DPP-IV抑制剂、包含此类制剂的片剂,和其用途和制备方法 (DPP-IV inhibitors in combination with other anti-diabetic agents, tablets comprising such formulations, and use and processes for preparation thereof)
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Colombia

Patent: 51277
Patent: INHIBIDOR DE LA DPP-IV COMBINADO CON MAS DE UN AGENTE ANTIDIABETICO, COMPRIMIDOS QUE COMPRENDEN TALES FORMULACIONES, SU USO Y PROCEDIMIENTOS PARA SU PREPARACIÓN.
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Denmark

Patent: 85410
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Ecuador

Patent: 10010489
Patent: Nuevas formulaciones, comprimidos que comprenden tales formulaciones, su uso y procedimiento para su preparación
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Eurasian Patent Organization

Patent: 9395
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, ВКЛЮЧАЮЩАЯ ИНГИБИТОР ДПП-4 И МЕТФОРМИН, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ТВЕРДАЯ ДОЗИРОВАННАЯ ФОРМА, ВКЛЮЧАЮЩАЯ УКАЗАННУЮ КОМПОЗИЦИЮ (PHARMACEUTICAL COMPOSITION COMPRISING A DPP-4 INHIBITOR AND METFORMIN, PROCESS FOR THE PREPARATION THEREOF AND SOLID DOSAGE FORM COMPRISING SAID COMPOSITION)
Estimated Expiration: ⤷  Sign Up

Patent: 8435
Patent: ПРИМЕНЕНИЕ ФАРМАЦЕВТИЧЕСКОЙ КОМПОЗИЦИИ В ВИДЕ ТАБЛЕТКИ С ПЛЕНОЧНЫМ ПОКРЫТИЕМ ДЛЯ ЛЕЧЕНИЯ САХАРНОГО ДИАБЕТА 2 ТИПА (USE OF A PHARMACEUTICAL COMPOSITION IN THE FORM OF A FILM-COATED TABLET IN TREATING TYPE 2 DIABETES MELLITUS)
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Patent: 1001577
Patent: ИНГИБИТОР ДПП-4 В КОМБИНАЦИИ С ДОПОЛНИТЕЛЬНЫМ ПРОТИВОДИАБЕТИЧЕСКИМ АГЕНТОМ, ТАБЛЕТКИ, ВКЛЮЧАЮЩИЕ УКАЗАННЫЕ КОМПОЗИЦИИ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ
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Patent: 1300121
Patent: ИНГИБИТОР ДПП-4 В КОМБИНАЦИИ С ДОПОЛНИТЕЛЬНЫМ ПРОТИВОДИАБЕТИЧЕСКИМ АГЕНТОМ, ТАБЛЕТКИ, ВКЛЮЧАЮЩИЕ УКАЗАННЫЕ КОМПОЗИЦИИ, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ
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European Patent Office

Patent: 85410
Patent: DPP-IV INHIBITEUR COMBINÉ AVEC UN AUTRE AGENT ANTI-DIABÉTIQUE, COMPRIMÉS COMPRENANT LESDITES FORMULATIONS, LEUR UTILISATION ET LEUR PROCÉDÉ DE PRÉPARATION (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
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Patent: 53403
Patent: INHIBITEUR DPP-IV COMBINÉ À UN AUTRE AGENT ANTIDIABÉTIQUE, COMPRIMÉS COMPRENANT DE TELLES FORMULATIONS, LEUR UTILISATION ET LEUR PROCÉDÉ DE PRÉPARATION (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
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Patent: 44374
Patent: INHIBITEUR DE DPP-IV COMBINÉ À UN AUTRE AGENT ANTIDIABÉTIQUE, COMPRIMÉS COMPRENANT DE TELLES FORMULATIONS, LEUR UTILISATION ET LEUR PROCÉDÉ DE PRÉPARATION (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
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Hong Kong

Patent: 49485
Patent: DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION
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Hungary

Patent: 41649
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Japan

Patent: 88428
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Patent: 22068
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Patent: 11516456
Estimated Expiration: ⤷  Sign Up

Patent: 13237707
Patent: NEW FORMULATION, TABLET COMPRISING THE FORMULATION, THE USE AND PROCESS FOR THE PREPARATION
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Mexico

Patent: 1232
Patent: INHIBIDOR DE DPP-IV COMBINADO CON OTRO AGENTE ANTIDIABETICO, TABLETAS QUE COMPRENDEN TALES FORMULACIONES, SU USO Y PROCEDIMIENTO PARA SU PREPARACION. (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION.)
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Patent: 10010819
Patent: INHIBIDORES DE DPP-IV COMBINADO CON OTRO AGENTE ANTIDIABETICO, TABLETAS QUE COMPRENDEN ESAS FORMULACIONES, SU USO Y PROCEDIMIENTO PARA SU PREPARACION. (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION.)
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Morocco

Patent: 200
Patent: صياغات جديدة، وأقراص تتكون من هذه الصيغ، استخدامها وطريقة تحضيرها
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New Zealand

Patent: 7747
Patent: Combination of 1-[(methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(piperidin-1-yl)-xanthine (BI-1356), metformin and a stabilising agent
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Patent: 9580
Patent: Dpp-iv inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 091730
Patent: FORMULACIONES QUE COMPRENDEN UN INHIBIDOR DE DPP4
Estimated Expiration: ⤷  Sign Up

Patent: 140960
Patent: FORMULACIONES QUE COMPRENDEN UN INHIBIDOR DE DPP4
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 85410
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1005664
Patent: DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1611314
Estimated Expiration: ⤷  Sign Up

Patent: 1775942
Estimated Expiration: ⤷  Sign Up

Patent: 110005690
Patent: DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION
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Patent: 160042174
Patent: 추가의 항당뇨병제와 병용된 DPP-IV 억제제, 이러한 제형을 포함하는 정제, 이들의 용도 및 이들의 제조 방법 (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
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Patent: 170056021
Patent: 추가의 항당뇨병제와 병용된 DPP-IV 억제제, 이러한 제형을 포함하는 정제, 이들의 용도 및 이들의 제조 방법 (- DPP-IV Inhibitor combined with a further antidiabetic agent tablets comprising such formulations their use and process for their preparation)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 96124
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 27816
Estimated Expiration: ⤷  Sign Up

Patent: 0946534
Patent: New formulations, tablets comprising such formulations, their use and process for their preparation
Estimated Expiration: ⤷  Sign Up

Patent: 1509941
Patent: New formulations, tablets comprising such formulations, their use and process for their preparation
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000431
Patent: NEW FORMULATIONS, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1818886
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4136
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ ВКЛЮЧАЕТ ИНГИБИТОР ДПП-4 В КОМБИНАЦИИ С ДОПОЛНИТЕЛЬНЫМ ПРОТИВОДИАБЕТИЧЕСКИМ АГЕНТОМ, И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО ВКЛЮЧАЄ ІНГІБІТОР ДПП-4 У КОМБІНАЦІЇ З ДОДАТКОВИМ ПРОТИДІАБЕТИЧНИМ АГЕНТОМ, ТА СПОСІБ ЇЇ ОДЕРЖАННЯ (DPP-IV INHIBITOR COMBINED WITH A FURTHER ANTIDIABETIC AGENT, TABLETS COMPRISING SUCH FORMULATIONS, THEIR USE AND PROCESS FOR THEIR PREPARATION)
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Uruguay

Patent: 747
Patent: NUEVAS FORMULACIONES, COMPRIMIDOS QUE COMPRENDEN TALES FORMULACIONES, SU USO Y PROCEDIMIENTO PARA SU PREPARACION
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 JENTADUETO around the world.

Country Patent Number Title Estimated Expiration
Canada 2875706 UTILISATIONS D'INHIBITEURS DE L'ENZYME DPP IV (USE OF DPP IV INHIBITORS) ⤷  Sign Up
Australia 2003253418 8-(3-AMINO-PIPERIDIN-1-YL)-XANTHINES, THE PRODUCTION THEREOF AND THE USE OF THE SAME AS MEDICAMENTS ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2009121945 ⤷  Sign Up
Eurasian Patent Organization 201300213 ПРИМЕНЕНИЕ ИНГИБИТОРОВ DPP IV ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JENTADUETO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CR 2011 00030 Denmark ⤷  Sign Up 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
1084705 C300708 Netherlands ⤷  Sign Up PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
0896538 300308 Netherlands ⤷  Sign Up 300308, 20170424, EXPIRES: 20220423
1084705 SPC/GB14/084 United Kingdom ⤷  Sign Up PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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