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Last Updated: November 4, 2024

tradjenta Drug Patent Profile


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When do Tradjenta patents expire, and when can generic versions of Tradjenta launch?

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

This drug has four hundred and fifty-nine patent family members in forty-five countries.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Tradjenta

A generic version of tradjenta was approved as linagliptin by SUNSHINE on August 31st, 2021.

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Drug patent expirations by year for tradjenta
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Drug Sales Revenue Trends for tradjenta

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Recent Clinical Trials for tradjenta

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SponsorPhase
EMSPhase 3
University of MiamiPhase 4
Northwell HealthPhase 4

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Pharmacology for tradjenta
Paragraph IV (Patent) Challenges for TRADJENTA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TRADJENTA Tablets linagliptin 5 mg 201280 11 2015-05-04

US Patents and Regulatory Information for tradjenta

tradjenta is protected by nine US patents and two FDA Regulatory Exclusivities.

Patents protecting tradjenta

Treatment for diabetes in patients inappropriate for metformin therapy
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Patent Expiration: ⤷  Sign Up

DPP IV inhibitor formulations
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Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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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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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Treatment for diabetes in patients inappropriate for metformin therapy
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Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
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Treatment for diabetes in patients inappropriate for metformin therapy
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FDA Regulatory Exclusivity protecting tradjenta

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 TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 tradjenta

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim TRADJENTA linagliptin TABLET;ORAL 201280-001 May 2, 2011 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for tradjenta

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Boehringer Ingelheim International GmbH Trajenta linagliptin EMEA/H/C/002110
Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Authorised no no no 2011-08-23
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for tradjenta

When does loss-of-exclusivity occur for tradjenta?

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

Argentina

Patent: 0755
Patent: FORMULACIONES DE INHIBIDORES DE DIPEPTIDIL PEPTIDASA IV (DPP IV)
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Patent: 9930
Patent: FORMULACIONES DE INHIBIDORES DE DIPEPTIDIL PEPTIDASA IV (DPP IV)
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Australia

Patent: 07247193
Patent: DPP IV inhibitor formulations
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Austria

Patent: 80228
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0711179
Patent: composição farmacêutica contendo composto inibidor de dpp iv e processo para a sua preparação
Estimated Expiration: ⤷  Sign Up

Patent: 0722388
Patent: Forma de dosagem oral farmacêutica preparada com uma composição farmacêutica compreendendo composto inibidor de dpp iv
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Canada

Patent: 49922
Patent: FORMULATIONS DE L'INHIBITEUR DE DPP IV (DPP IV INHIBITOR FORMULATIONS)
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Chile

Patent: 12002521
Patent: Composicion farmaceutica que comprende un inhibidor de dpp iv seleccionado de un grupo definido, un primer diluyente, un segundo diluyente: manitol, un segundo diluyente: almidon pregelatinizado, un aglutinante y un lubricante; util en el tratamiento de diabetes. (divisional de la sol. 1260-07).
Estimated Expiration: ⤷  Sign Up

Patent: 12002522
Patent: Composición farmacéutica que comprende un compuesto inhibidor de dpp iv con un grupo amino o una sal del mismo , un primer diluyente , un segundo diluyente ,un aglutinante , un disgregante y un lubricante, útil en el tratamiento de diabetes mellitus.
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China

Patent: 1437493
Patent: DPP IV inhibitor formulations
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Patent: 2526737
Patent: DPP IV inhibitor formulations
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Croatia

Patent: 0100507
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Patent: 0150003
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Cyprus

Patent: 11354
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Patent: 16064
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Denmark

Patent: 23902
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Patent: 77509
Estimated Expiration: ⤷  Sign Up

Patent: 83819
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 088800
Patent: Formulaciones de inhibidores de DPP IV
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Eurasian Patent Organization

Patent: 6559
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV (DPP IV INHIBITOR FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Patent: 9890
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ В ПЕРОРАЛЬНОЙ ДОЗИРОВАННОЙ ЛЕКАРСТВЕННОЙ ФОРМЕ НА ОСНОВЕ ИНГИБИТОРА DPP IV (PHARMACEUTICAL COMPOSITION AND PHARMACEUTICAL COMPOSITION IN ORAL DOSAGE FORM BASED ON DPP IV INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Patent: 0802184
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV
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Patent: 1100958
Patent: ФАРМАЦЕВТИЧЕСКАЯ ПЕРОРАЛЬНАЯ ДОЗИРОВАННАЯ ЛЕКАРСТВЕННАЯ ФОРМА НА ОСНОВЕ ИНГИБИТОРОВ DPP IV
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European Patent Office

Patent: 52108
Patent: Compositions d'inhibiteurs de la DPP IV (DPP IV inhibitor formulations)
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Patent: 23902
Patent: FORMULATIONS DE L'INHIBITEUR DE DPP IV (DPP IV INHIBITOR FORMULATIONS)
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Patent: 77509
Patent: Compositions d'inhibiteurs de la DPP IV (DPP IV inhibitor formulations)
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Patent: 83819
Patent: Compositions d'inhibiteurs de la DPP IV (DPP IV inhibitor formulations)
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Patent: 10241
Patent: Formules d'inhibiteur dpp iv (DPP IV INHIBITOR FORMULATIONS)
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Germany

Patent: 2007009091
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Hong Kong

Patent: 30442
Patent: DPP IV INHIBITOR FORMULATIONS
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Patent: 72549
Patent: 二肽基肽酶 抑制劑製劑 (DPP IV INHIBITOR FORMULATIONS IV)
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Hungary

Patent: 25210
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Israel

Patent: 5030
Patent: הרכבים של מעכב iv dpp (Dpp iv inhibitor formulations)
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Japan

Patent: 78244
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Patent: 00998
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Patent: 64720
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Patent: 87908
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Patent: 84711
Estimated Expiration: ⤷  Sign Up

Patent: 09535376
Estimated Expiration: ⤷  Sign Up

Patent: 12072187
Patent: DPP IV INHIBITOR FORMULATION
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Patent: 13227338
Patent: DPP IV INHIBITOR FORMULATION
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Patent: 16104811
Patent: DPPIVインヒビター製剤 (DPP IV INHIBITOR PREPARATIONS)
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Patent: 18021082
Patent: DPP IVインヒビター製剤 (DPP IV INHIBITOR FORMULATIONS)
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Patent: 20079316
Patent: DPP IVインヒビター製剤 (DPP IV INHIBITOR FORMULATIONS)
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Patent: 22075826
Patent: DPP IVインヒビター製剤
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Malaysia

Patent: 6969
Patent: DPP IV INHIBITOR FORMULATIONS
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Patent: 8496
Patent: DPP IV INHIBITOR FORMULATIONS
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Mexico

Patent: 8617
Patent: FORMULACIONES DE INHIBIDORES DE DPP IV. (DPP IV INHIBITOR FORMULATIONS.)
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Patent: 08013958
Patent: FORMULACIONES DE INHIBIDORES DE DPP IV. (DPP IV INHIBITOR FORMULATIONS.)
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Montenegro

Patent: 170
Patent: FORMULACIJE DPP IV INHIBITORA (DPP IV INHIBITOR FORMULATIONS)
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Patent: 941
Patent: Formulacije DPP IV inhibitora (DPP IV inhibitor formulations)
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New Zealand

Patent: 2862
Patent: DPP IV inhibitor formulations which comprise mannitol, pregelatinised starch, copovidone, corn starch and magnesium stearate
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Patent: 5983
Patent: DPP IV inhibitor formulations
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Patent: 3426
Patent: Dpp iv inhibitor formulations
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Norway

Patent: 3067
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Patent: 084256
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Peru

Patent: 080698
Patent: COMPOSICIONES FARMACEUTICAS DE INHIBIDORES DE DPP IV
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Patent: 110666
Patent: COMPOSICIONES FARMACEUTICAS DE INHIBIDORES DE DPP IV
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Poland

Patent: 23902
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Patent: 77509
Estimated Expiration: ⤷  Sign Up

Patent: 83819
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Portugal

Patent: 23902
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Patent: 83819
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Serbia

Patent: 466
Patent: FORMULACIJE DPP IV INHIBITORA (DPP IV INHIBITOR FORMULATIONS)
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Patent: 570
Patent: FORMULACIJE DPP IV INHIBITORA (DPP IV INHIBITOR FORMULATIONS)
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Singapore

Patent: 1649
Patent: DPP IV INHIBITOR FORMULATIONS
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Slovenia

Patent: 23902
Estimated Expiration: ⤷  Sign Up

Patent: 83819
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South Africa

Patent: 0808361
Patent: DPP IV inhibitor formulations
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South Korea

Patent: 1478983
Estimated Expiration: ⤷  Sign Up

Patent: 1710881
Estimated Expiration: ⤷  Sign Up

Patent: 1855323
Estimated Expiration: ⤷  Sign Up

Patent: 2051281
Estimated Expiration: ⤷  Sign Up

Patent: 090009226
Patent: DPP IV INHIBITOR FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Patent: 140063896
Patent: DPP IV INHIBITOR FORMULATIONS
Estimated Expiration: ⤷  Sign Up

Patent: 150100957
Patent: DPP IV INHIBITOR FORMULATIONS
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Patent: 160128446
Patent: DPP IV 억제제 제형 (DPP IV inhibitor formulations)
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Patent: 170141812
Patent: DPP IV 억제제 제형 (DPP IV inhibitor formulations)
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Spain

Patent: 48576
Estimated Expiration: ⤷  Sign Up

Patent: 27409
Estimated Expiration: ⤷  Sign Up

Patent: 38818
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Taiwan

Patent: 74843
Estimated Expiration: ⤷  Sign Up

Patent: 20753
Estimated Expiration: ⤷  Sign Up

Patent: 0812648
Patent: DPP IV inhibitor formulations
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Patent: 1417844
Patent: DPP IV inhibitor formulations
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Ukraine

Patent: 942
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ С ИНГИБИТОРАМИ DPP IV;ФАРМАЦЕВТИЧНІ КОМПОЗИЦІЇ З ІНГІБІТОРАМИ DPP IV (DPP IV INHIBITOR FORMULATIONS)
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 319
Patent: FORMULACIONES DE INHIBIDORES DE DPP IV
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 tradjenta around the world.

Country Patent Number Title Estimated Expiration
Uruguay 30321 PROCEDIMIENTO PARA PREPARAR MEDICAMENTOS CARACTERIZADO POR EL USO DE DERIVADOS SUSTITUIDOS DE LA 3-METIL-7-(2-BUTIN-1-IL) XANTINA Y APLICACIONES ⤷  Sign Up
South Korea 101440796 ⤷  Sign Up
China 1269528 ⤷  Sign Up
Australia 766219 ⤷  Sign Up
South Korea 101478983 ⤷  Sign Up
Taiwan I520753 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tradjenta

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 PA2014045 Lithuania ⤷  Sign Up PRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1532149 C 2012 003 Romania ⤷  Sign Up 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
1532149 SPC/GB12/006 United Kingdom ⤷  Sign Up 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
1084705 SPC/GB14/086 United Kingdom ⤷  Sign Up PRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928
1084705 C300705 Netherlands ⤷  Sign Up PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
2187879 LUC00017 Luxembourg ⤷  Sign Up PRODUCT NAME: GLYXAMBI- EMPAGLIFLOZINE/LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/16/1146 20161115
>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.