jardiance Drug Patent Profile
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Which patents cover Jardiance, and what generic alternatives are available?
Jardiance is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and eighty patent family members in forty-five countries.
The generic ingredient in JARDIANCE is empagliflozin. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the empagliflozin profile page.
DrugPatentWatch® Generic Entry Outlook for Jardiance
Jardiance was eligible for patent challenges on August 1, 2018.
Annual sales in 2021 were $7.6bn, indicating a strong incentive for generic entry.
There have been fifteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are fourteen tentative approvals for the generic drug (empagliflozin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
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Summary for jardiance
| International Patents: | 280 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 91 |
| Clinical Trials: | 75 |
| Patent Applications: | 686 |
| Drug Prices: | Drug price information for jardiance |
| Drug Sales Revenues: | Drug sales revenues for jardiance |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for jardiance |
| What excipients (inactive ingredients) are in jardiance? | jardiance excipients list |
| DailyMed Link: | jardiance at DailyMed |
Recent Clinical Trials for jardiance
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 4 |
| Rigshospitalet, Denmark | Phase 4 |
| Novo Nordisk A/S | Phase 3 |
Pharmacology for jardiance
| Drug Class | Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for JARDIANCE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JARDIANCE | Tablets | empagliflozin | 10 mg and 25 mg | 204629 | 14 | 2018-08-01 |
US Patents and Regulatory Information for jardiance
jardiance is protected by twelve US patents and six FDA Regulatory Exclusivities.
Patents protecting jardiance
Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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Patented Use: TREATMENT AND REDUCTION OF RISK BY ADMINISTRATION OF EMPAGLIFLOZIN TO ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
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Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN
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Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION IN PATIENTS WITH HEART FAILURE BY ADMINISTRATION OF EMPAGLIFLOZIN
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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND
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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND
Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
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Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
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Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivate
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Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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FDA Regulatory Exclusivity protecting jardiance
REDUCE THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH HEART FAILURE AND REDUCED EJECTION FRACTION
Exclusivity Expiration: ⤷ Sign Up
USE OF EMPAGLIFLOZIN TO REDUCE THE RISK OF SUSTAINED DECLINE IN EGFR, END-STAGE KIDNEY DISEASE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION IN ADULTS WITH CHRONIC KIDNEY DISEASE AT RISK OF PROGRESSION
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NEW PATIENT POPULATION
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LABELING REVISIONS RELATED TO CLINICAL STUDIES
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PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-002 | Aug 1, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-002 | Aug 1, 2014 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-001 | Aug 1, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-001 | Aug 1, 2014 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JARDIANCE | empagliflozin | TABLET;ORAL | 204629-002 | Aug 1, 2014 | 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 |
EU/EMA Drug Approvals for jardiance
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim International GmbH | Jardiance | empagliflozin | EMEA/H/C/002677 Type 2 diabetes mellitusJardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesFor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4.4, 4.5 and 5.1. of the annex.Heart failureJardiance is indicated in adults for the treatment of symptomatic chronic heart failure. Chronic kidney diseaseJardiance is indicated in adults for the treatment of chronic kidney disease. |
Authorised | no | no | no | 2014-05-22 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for jardiance
When does loss-of-exclusivity occur for jardiance?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7970
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
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Patent: 7657
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
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Australia
Patent: 08288407
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Brazil
Patent: 0815331
Patent: composição farmacêutica compreendendo um derivado de benzeno glucopiranosila substituída
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 96558
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DERIVE DE BENZENE A SUBSTITUTION GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08002427
Patent: Composicion farmaceutica que comprende 1-cloro-4-(b-d-glucopiranos-1-il)-2-[4-((s)-tetrahidrofurano-3-iloxi)bencil]-benceno combinado con 1-[(4-metilquinazolin-2-il)metil]-3-metil-7-(2-butin-1-il)-8-(3-(r)-aminopiperidin-1-il)xantina; y su uso para tratar diabetes mellitus tipo 2.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1784270
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Patent: 4288166
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Patent: 4353077
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Colombia
Patent: 51239
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO JUNTO CON UN INHIBIDOR DE DPP IV
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0170022
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Cyprus
Patent: 18308
Estimated Expiration: ⤷ Sign Up
Patent: 17017
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Denmark
Patent: 87879
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Ecuador
Patent: 109977
Patent: Composición farmacéutica que comprende un derivado de benceno sustituido con glucopiranosilo.
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Eurasian Patent Organization
Patent: 8608
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГЛЮКОПИРАНОЗИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ БЕНЗОЛА И ИНГИБИТОР DPP IV (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE AND DPP IV INHIBITOR)
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Patent: 1000321
Patent: ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГЛЮКОПИРАНОЗИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ БЕНЗОЛА
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European Patent Office
Patent: 87879
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE À SUBSTITUTION GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
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Patent: 98152
Patent: Composition pharmaceutique comprenant un dérivé de benzène substitué de glucopyranosyl (Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative)
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Patent: 06156
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE SUBSTITUÉ PAR GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
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Patent: 39577
Patent: COMPOSITION PHARMACEUTIQUE COMPRENANT UN DÉRIVÉ DE BENZÈNE SUBSTITUÉ PAR GLUCOPYRANOSYLE (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 01721
Patent: 包含吡喃葡萄糖基-取代的苯衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL SUBSTITUTED BENZENE DERIVATIVE)
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Patent: 03351
Patent: 包含吡喃葡萄糖基-取代的苯衍生物的藥物組合物 (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL SUBSTITUTED BENZENE DERIVATIVE)
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Hungary
Patent: 30158
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Patent: 700020
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Israel
Patent: 2886
Patent: תכשיר רוקחות המכיל תולדת בנזן המותמרת בגלוקופיראנוזיל, באופן בריירתי המכילה בנוסף מעכב iv dpp ושימוש בו לייצור תרופה המונעת, מאיטה, מעכבת או מטפלת באי סדר מטבולי (Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative, optionally further comprising a dpp iv inhibitor and use thereof in the manufacture of a medicament for preventing, slowing, delaying or treating a metabolic disorder)
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Japan
Patent: 95914
Estimated Expiration: ⤷ Sign Up
Patent: 10535850
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 187879
Estimated Expiration: ⤷ Sign Up
Patent: 2017014
Estimated Expiration: ⤷ Sign Up
Patent: 87879
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 2037
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
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Mexico
Patent: 10001696
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO. (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTE D BENZENE DERIVATIVE.)
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 573
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI GLUKOPIRANOZILOM SUPSTITUISANI DERIVAT BENZENA (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 612
Patent: COMPOSITION PHARMACEUTIQUE CONTENANT UN DERIVE DE BENZENE SUBSTITUE PAR GLUCOPYRANOSYLE
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Netherlands
Patent: 0872
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3242
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
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Norway
Patent: 17020
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Peru
Patent: 090938
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 87879
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 87879
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 205
Patent: FARMACEUTSKA KOMPOZICIJA KOJA SADRŽI GLUKOPIRANOZILOM SUPSTITUISANI DERIVAT BENZENA (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
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Slovenia
Patent: 87879
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South Africa
Patent: 0909105
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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South Korea
Patent: 1491554
Estimated Expiration: ⤷ Sign Up
Patent: 100049595
Patent: PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 02748
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 72325
Estimated Expiration: ⤷ Sign Up
Patent: 0914030
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Patent: 1436798
Patent: Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative
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Tunisia
Patent: 10000073
Patent: COMPOSITON PHARMACEUTIQUE CONTENANT UN DERIVE DE BENZENE SUBSTITUE PAR GLUCOPYRANOSYLE
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Ukraine
Patent: 0384
Patent: ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ГЛЮКОПІРАНОЗИЛЗАМІЩЕНУ ПОХІДНУ БЕНЗОЛУ ТА ІНГІБІТОР DPP IV (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE)
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 296
Patent: COMPOSICION FARMACÉUTICA QUE COMPRENDE UN DERIVADO DE BENCENO SUSTITUIDO CON GLUCOPIRANOSILO
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 jardiance around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Peru | 20120017 | COMPOSICION FARMACEUTICA QUE COMPRENDE UN INHIBIDOR DE SGLT2, UN INHIBIDOR DE DPP-IV, OPCIONALMENTE, UN AGENTE ANTIDIABETICO ADICIONAL, Y SUS USOS | ⤷ Sign Up |
| Serbia | 52365 | DERIVATI BENZOLA SUPSTITUISANI GLUKOPIRANOZILOM, LEKOVI KOJI SADRŽE OVA JEDINJENJA, NJIHOVA PRIMENA I POSTUPAK ZA NJIHOVO DOBIJANJE (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Sign Up |
| China | 104353077 | Pharmaceutical composition comprising a glucopyranosyl-substituted benzene derivative | ⤷ Sign Up |
| Norway | 20064201 | ⤷ Sign Up | |
| Eurasian Patent Organization | 018608 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ГЛЮКОПИРАНОЗИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ БЕНЗОЛА И ИНГИБИТОР DPP IV (PHARMACEUTICAL COMPOSITION COMPRISING A GLUCOPYRANOSYL-SUBSTITUTED BENZENE DERIVATIVE AND DPP IV INHIBITOR) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for jardiance
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | C01730131/05 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 30.06.2022 |
| 2187879 | 276 10-2017 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN/LINAGLIPTIN VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
| 1730131 | C300696 | Netherlands | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINE EN ZOUTEN DAARVAN, IN HET BIJZONDER EMPAGLIFLOZINE; REGISTRATION NO/DATE: EU/1/14/930/001-009 20140522 |
| 1730131 | C01730131/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC 63227 12.11.2014 |
| 2187879 | SPC/GB17/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: 1-CHLORO-4-(SS-D-GLUCOPYRANOS-1-YL)-2-(4-((S)-TETRAHYDROFURAN-3-YLOXY)-BENZYL)-BENZENE (I.E. EMPAGLIFLOZIN) IN COMBINATION WITH 1-((4 METHYL-QUINAZOLIN-2-YL)METHYL)-3-METHYL-7-(2-BUTYN-1-YL)-8-(3-(R)-AMINO-PIPERIDIN-1-YL)-XANTHINE (I.E. LINAGLIPTIN) OR A P; REGISTERED: UK PLGB 14598/0191 (GB) 20161115; UK EU/1/16/1146/014(NI) 20161115; UK EU/1/16/1146/015(NI) 20161115; UK EU/1/16/1146/016(NI) 20161115; UK EU/1/16/1146/017(NI) 20161115; UK EU/1/16/1146/018(NI) 20161115; UK EU/1/16/1146/007(NI) 20161115; UK EU/1/16/1146/001(NI) 20161115; UK EU/1/16/1146/013(NI) 20161115; UK EU/1/16/1146/002(NI) 20161115; UK EU/1/16/1146/003(NI) 20161115; UK EU/1/16/1146/004(NI) 20161115; UK... |
| >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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