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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Summary for TRADJENTA
| International Patents: | 459 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 10 |
| Patent Applications: | 1,600 |
| Drug Prices: | Drug price information for TRADJENTA |
| Drug Sales Revenues: | Drug sales revenues for TRADJENTA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TRADJENTA |
| What excipients (inactive ingredients) are in TRADJENTA? | TRADJENTA excipients list |
| DailyMed Link: | TRADJENTA at DailyMed |
Recent Clinical Trials for TRADJENTA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| EMS | Phase 3 |
| University of Miami | Phase 4 |
| Northwell Health | Phase 4 |
Pharmacology for TRADJENTA
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
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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DPP IV inhibitor formulations
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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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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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Patent Expiration: ⤷ Sign Up
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 | ||
| 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)
Estimated Expiration: ⤷ Sign Up
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
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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)
Estimated Expiration: ⤷ Sign Up
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.
Estimated Expiration: ⤷ Sign Up
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
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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)
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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
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Patent: 09535376
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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
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
Patent: 77509
Estimated Expiration: ⤷ Sign Up
Patent: 83819
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Portugal
Patent: 23902
Estimated Expiration: ⤷ Sign Up
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
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0808361
Patent: DPP IV inhibitor formulations
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South Korea
Patent: 1478983
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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
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Patent: 140063896
Patent: DPP IV INHIBITOR FORMULATIONS
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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
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Patent: 27409
Estimated Expiration: ⤷ Sign Up
Patent: 38818
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 74843
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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
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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 |
|---|---|---|---|
| Japan | 2020172554 | 経口又は非経口抗糖尿病薬による治療にもかかわらず不十分な血糖調節の患者の糖尿病の治療 (TREATMENT FOR DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ORAL OR NON-ORAL ANTIDIABETIC DRUG) | ⤷ Sign Up |
| Malaysia | 174080 | USE OF DPP IV INHIBITORS | ⤷ Sign Up |
| Japan | 6100998 | ⤷ Sign Up | |
| European Patent Office | 2308878 | 8-[3-AMINO-PIPERIDIN-1-YL] -XANTHINES, LEUR PRODUCTION ET LEUR UTILISATION COMME MEDICAMENT (8-[3-AMINO-PIPERIDIN-1-YL]-XANTHINES, THE PRODUCTION THEREOF AND USE AS MEDICAMENTS) | ⤷ Sign Up |
| South Africa | 200808361 | DPP IV inhibitor formulations | ⤷ Sign Up |
| Austria | E480228 | ⤷ Sign Up | |
| Norway | 336641 | ⤷ 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 | CR 2014 00063 | Denmark | ⤷ Sign Up | 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 20070323 |
| 1084705 | C300705 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 |
| 1084705 | CA 2014 00063 | Denmark | ⤷ Sign Up | 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 |
| 1084705 | PA2014043 | Lithuania | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001 |
| 1084705 | CR 2014 00062 | Denmark | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091005 |
| 1084705 | C01084705/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007 |
| 1532149 | PA2011013,C1532149 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011-08-24 EU/1/11/707/002, 2011-08-24 EU/1/11/707/003, 2011-08-24 EU/1/11/707/004, 2011-08-24 EU/1/11/707/005, 2011-08-24 EU/1/11/707/006, 2011-08-24 EU/1/11/707/007, 2011-08-24 EU/1/11/707/008, 2011-08-24 EU/1/11/707/00 2011082 |
| >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.
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