Methods Of Treating Chronic Kidney Disease With Dapagliflozin - EP4188389

The patent EP4188389 was granted to Astrazeneca on Sep 17, 2025. The application was originally filed on Apr 1, 2021 under application number EP21716724A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP4188389

ASTRAZENECA
Application Number
EP21716724A
Filing Date
Apr 1, 2021
Status
Granted And Under Opposition
Aug 15, 2025
Grant Date
Sep 17, 2025
External Links
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GENERICS UKSep 17, 2025ELKINGTON AND FIFEADMISSIBLE

Patent Citations (75) New

Patent citations refer to prior patents cited during different phases such as opposition or international search.

Citation PhasePublication NumberPublication Link
DESCRIPTIONEP0598359
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DESCRIPTIONWO9938501
DESCRIPTIONWO9946272
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Non-Patent Literature (NPL) Citations (40) New

NPL citations refer to non-patent references such as research papers, articles, or other publications cited during examination or opposition phases.

Citation PhaseReference TextLink
DESCRIPTION- ASHWORTH et al., Bioorg. & Med. Chem., (19960000), vol. 6, no. 22, pages 1163 - 1166,2745-2748-
DESCRIPTION- "Design and Application of Prodrugs", H. BUNDGAARD, A Textbook of Drug Design and Development, (19910000), pages 113 - 191-
DESCRIPTION- ECKARDT, K-U et al., Lancet, (20130000), vol. 382, no. 9887, pages 158 - 169-
DESCRIPTION- H. BUNDGAARD, Advanced Drug Delivery Reviews, (19920000), vol. 8, pages 1 - 38-
DESCRIPTION- H. BUNDGAARD et al., Journal of Pharmaceutical Sciences, (19880000), vol. 77, page 285-
DESCRIPTION- HONGU, M. et al., Chem. Pharm. Bull., (19980000), vol. 46, pages 1545 - 1555-
DESCRIPTION- HUGHES et al., Biochemistry, (19990000), vol. 38, no. 36, pages 11597 - 11603-
DESCRIPTION- INZUCCHI et al., Diabetes & Vascular Dis Res, (20150000), vol. 12, no. 2, pages 90 - 100-
DESCRIPTION- Methods in Enzymology, Academic Press, (19850000), vol. 42, pages 309 - 396-
DESCRIPTION- MURAKAMI et al., "A Novel Insulin Sensitizer Acts As a Coligand for Peroxisome Proliferation-Activated Receptor Alpha (PPAR alpha) and PPAR gamma. Effect on PPAR alpha Activation on Abnormal Lipid Metabolism in Liver of Zucker Fatty Rats", Diabetes, (19980000), vol. 47, pages 1841 - 1847-
DESCRIPTION- N. KAKEYA et al., Chem Pharm Bull, (19840000), vol. 32, page 692-
DESCRIPTION- OKU, A. et al., Diabetes, (19990000), vol. 48, pages 1794 - 1800-
DESCRIPTION- TSUJIHARA, K. et al., Chem. Pharm. Bull., (19960000), vol. 44, pages 1174 - 1180-
DESCRIPTION- YAMADA et al., Bioorg. & Med. Chem. Lett., (19980000), vol. 8, pages 1537 - 1540-
DESCRIPTION- YANCY C.W. et al., "ACC/AHA/HFSA focused update of the 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association task force on clinical practice guidelines and the Heart Failure Society of America, J", Am Coll Cardiol, (20170000), vol. 70, no. 6, pages 776 - 803-
EXAMINATION- COWIE MARTIN R ET AL, "SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control", NATURE REVIEWS CARDIOLOGY, NATURE PUBLISHING GROUP, GB, vol. 17, no. 12, doi:10.1038/S41569-020-0406-8, ISSN 1759-5002, (20200714), pages 761 - 772, (20200714), XP037287692
INTERNATIONAL-SEARCH-REPORT- ALLEGRETTI ANDREW S ET AL, "Safety and Effectiveness of Bexagliflozin in Patients With Type 2 Diabetes Mellitus and Stage 3a/3b CKD", AMERICAN JOURNAL OF KIDNEY DISEASES, W.B. SAUNDERS, PHILADELPPHIA, PA, US, vol. 74, no. 3, doi:10.1053/J.AJKD.2019.03.417, ISSN 0272-6386, (20190514), pages 328 - 337, (20190514), XP085790822 [X] 1-3,5,58,59 * figure 1 *
INTERNATIONAL-SEARCH-REPORT- KETTELER MARKUS ET AL, "Chronisches Nierenversagen - [Chronic Kidney Disease - Update 2018]", DEUTSCHE MEDIZINISCHE WOCHENSCHRIFT : DMW : ORGAN DER DEUTSCHEN GESELLSCHAFT FÜR INNERE MEDIZIN (DGIM) : ORGAN DER GESELLSCHAFT DEUTSCHER NATURFORSCHER UND ÄRZTE (GDNÄ), THIEME, DE, (20180131), vol. 143, no. 3, doi:10.1055/S-0043-124831, ISSN 1439-4413, pages 169 - 173, XP009528237 [X] 4 * Ein Blick in die Zukunft *
INTERNATIONAL-SEARCH-REPORT- KELLY MICHAEL S. ET AL, "Efficacy and renal outcomes of SGLT2 inhibitors in patients with type 2 diabetes and chronic kidney disease", POSTGRADUATE MEDICINE., US, vol. 131, no. 1, doi:10.1080/00325481.2019.1549459, ISSN 0032-5481, (20190102), pages 31 - 42, URL: http://dx.doi.org/10.1080/00325481.2019.1549459, XP055815767 [X] 1-3,5,6,58,59 * figure 3; table 2 *
INTERNATIONAL-SEARCH-REPORT- J.-F. YALE ET AL, "Efficacy and safety of canagliflozin over 52 weeks in patients with type 2 diabetes mellitus and chronic kidney disease", DIABETES, OBESITY AND METABOLISM, GB, (20140722), vol. 16, no. 10, doi:10.1111/dom.12348, ISSN 1462-8902, pages 1016 - 1027, XP055700544 [X] 1-3,5,6,17,18,58,59 * tables 1, 4 *
INTERNATIONAL-SEARCH-REPORT- TOYAMA TADASHI ET AL, "Effect of SGLT2inhibitors on cardiovascular, renal and safety outcomes in patients with type 2 diabetes mellitus and chronic kidney disease: A systematic review and meta-analysis", vol. 21, no. 5, doi:10.1111/DOM.13648, ISSN 1463-1326, (20190430), pages 1237 - 1250, DIABETES, OBESITY AND METABOLISM, WILEY-BLACKWELL PUBLISHING LTD, GB, URL: https://onlinelibrary.wiley.com/doi/full/10.1111/dom.13648, XP009528195 [X] 1-3,5,6,58 * figures 1, 2 *
INTERNATIONAL-SEARCH-REPORT- YAMOUT HALA ET AL, "Efficacy and Safety of Canagliflozin in Patients with Type 2 Diabetes and Stage 3 Nephropathy", AMERICAN JOURNAL OF NEPHROLOGY, CH, vol. 40, no. 1, doi:10.1159/000364909, ISSN 0250-8095, (20140101), pages 64 - 74, URL: https://www.karger.com/Article/Pdf/364909, XP055815769 [X] 1-3,5,6 * figure 3; table 2 *
INTERNATIONAL-SEARCH-REPORT- SUGIYAMA SEIGO ET AL, "Renoprotective Effects of Additional SGLT2inhibitor Therapy in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease Stages 3b-4: A Real World Report From A Japanese Specialized Diabetes Care Center", vol. 11, no. 4, doi:10.14740/JOCMR3761, ISSN 1918-3003, (20190331), pages 267 - 274, JOURNAL OF CLINICAL MEDICINE RESEARCH, ELMER PRESS INC, CA, URL: https://www.ncbi.nlm.nih.gov/pmc/ivip/1918-3003/11/4/267, XP009528194 [X] 1-4,17-20,24,58,59 * tables 1,2,3 *
OPPOSITION- Anonymous, "First-quarter 2020 results", (20200429), XP093285326-
OPPOSITION- Anonymous, "Guidance for Industry Diabetes Mellitus — Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes", U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), (20081201), pages 1 - 8, XP093121420-
OPPOSITION- Astra Zeneca, "Farxiga Phase III DAPA-CKD trial will be stopped early after overwhelming efficacy in patients with chronic kidney disease", (20200330), URL: https://www.astrazeneca.com/media-centre/press-releases/2020/farxiga-phase-iii-dapa-ckd-trial-will-be-stopped-early-after-overwhelming-efficacy-in-patients-with-chronic-kidney-disease.html#!, XP093211795-
OPPOSITION- D1a - Evidence of publication date for D1-
OPPOSITION- D3a - Evidence of publication date for D3-
OPPOSITION- Deichmann et al., "Bioethics in practice: Considerations for stopping a clinical trial early", Ochsner J. , (2016), vol. 16, XP093300904-
OPPOSITION- Dekkers Claire C.; Gansevoort Ron T.; Heerspink Hiddo J., "New Diabetes Therapies and Diabetic Kidney Disease Progression: the Role of SGLT-2 Inhibitors", CURRENT DIABETES REPORTS, CURRENT SCIENCE, PHILADELPHIA, VA, US, US , (20180327), vol. 18, no. 5, doi:10.1007/s11892-018-0992-6, ISSN 1534-4827, pages 1 - 12, XP036467947
OPPOSITION- ZINMAN BERNARD ET AL, "Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes", NEW ENGLAND JOURNAL OF MEDICINE, (20151101), vol. 373, no. 22, doi:10.1056/NEJMoa1504720, pages 2117 - 2128, XP002769966
OPPOSITION- Neal Bruce; Perkovic Vlado; Mahaffey Kenneth W; de Zeeuw Dick; Fulcher Greg; Erondu Ngozi; Shaw Wayne; Law Gordon; Desai Mehul; Matthews David R; CANVAS Program Collaborative Grp, "Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes", The new England journal of medicine, Eli Lily and Company, USA, USA, (20170817), vol. 377, no. 7, doi:10.1056/NEJMoa1611925, pages 644 - 657, XP009520745
OPPOSITION- Perkovic Vlado, Jardine Meg J., Neal Bruce, Bompoint Severine, Heerspink Hiddo J.L., Charytan David M., Edwards Robert, Agarwal Rajiv, Bakris George, Bull Scott, Cannon Christopher P., Capuano George, Chu Pei-Ling, De Zeeuw Dick, Greene Tom, Levin Adeera, Pollock Carol, Wheeler David C., Yavin Yshai, Zhang Hong, Zinman Bernard, Meininger Gary, Brenner Barry M., Mahaffey Kenneth W., "Canagliflozin and Renal Outcomes in Type 2 Diabetes and Nephropathy", The new England journal of medicine, Eli Lily and Company, USA, USA, (20190613), vol. 380, no. 24, doi:10.1056/NEJMoa1811744, pages 2295 - 2306, XP093177307
OPPOSITION- Wiviott Stephen D., Raz Itamar, Bonaca Marc P., Mosenzon Ofri, Kato Eri T., Cahn Avivit, Silverman Michael G., Zelniker Thomas A., Kuder Julia F., Murphy Sabina A., Bhatt Deepak L., Leiter Lawrence A., Mcguire Darren K., Wilding John P.H., Ruff Christian T., Gause-Nilsson Ingrid A.M., Fredriksson Martin, Johansson Peter A., Langkilde Anna-Maria, Sabatine Marc S., "Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes", New England Journal of Medicine, Massachusetts Medical Society, United States, United States, (20190124), vol. 380, no. 4, doi:10.1056/NEJMoa1812389, ISSN 0028-4793, pages 347 - 357, XP093317146
OPPOSITION- John J.V. Mcmurray, Scott D. Solomon, Silvio E. Inzucchi, Lars Køber, Mikhail N. Kosiborod, Felipe A. Martinez, Piotr Ponikowski, Marc S. Sabatine, Inder S. Anand, Jan Bělohlávek, Michael Böhm, Chern-En Chiang, Vijay K. Chopra, Rudolf A. De Boer, Akshay S. Desai, Mirta Diez, Jaroslaw Drozdz, Andrej Dukát, Junbo Ge, Jonathan G. Howlett, Tzvetana Katova, Masafumi Kitakaze, Charlotta E.A. Ljungman, Béla Merkely, Jose C. Nicolau, Eileen O’meara, Mark C. Petrie, Pham N. Vinh, Morten Schou, Sergey Tereshchenko, Subodh Verma, Claes Held, David L. Demets, Kieran F. Docherty, Pardeep S. Jhund, Olof Bengtsson, Mikaela Sjöstrand, Anna-Maria Langkilde, "Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction", The new England journal of medicine, Eli Lily and Company, USA, USA, (20191121), vol. 381, no. 21, doi:10.1056/NEJMoa1911303, pages 1995 - 2008, XP055700213
OPPOSITION- Heerspink et al., "Rationale and protocol of the Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial", Nephrol. Dial. Transplant, (2020), vol. 35, doi:10.1093/ndt/gfz290, XP093282731
OPPOSITION- Rajasekeran Harindra, Cherney David Z., Lovshin Julie A., "Do effects of sodium-glucose cotransporter-2 inhibitors in patients with diabetes give insight into potential use in non-diabetic kidney disease? ", CURRENT OPINION IN NEPHROLOGY AND HYPERTENSION., RAPID SCIENCE, LONDON., GB, GB , (20170901), vol. 26, no. 5, doi:10.1097/MNH.0000000000000343, ISSN 1062-4813, pages 358 - 367, XP009563207
OTHER- Deichmann R. E., Krousel-Wood, M.Breault, J., "Bioethics in Practice: Considerations for Stopping a Clinical Trial Early", Ochsner Journal, (20160101), vol. 16, no. 3, pages 197 - 198, XP093300904-
OTHER- Cowie Martin R.; Fisher Miles, "SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control", Nature Reviews Cardiology, GB , (20200714), vol. 17, no. 12, doi:10.1038/s41569-020-0406-8, ISSN 1759-5002, pages 761 - 772, XP037287692
OTHER- Heerspink Hiddo J, Stefansson Bergur V, Chertow Glenn M, Correa-Rotter Ricardo, Greene Tom, Hou Fan-Fan, Lindberg Magnus, Mcmurray John, Rossing Peter, Toto Roberto, Langkilde Anna Maria, Wheeler David C, Heerspink H J L, Wheeler D C, Chertow G, Correa-Rotter R, Greene T, Hou F-F, Mcmurray J, Rossing P, Toto R, Stefansson B, Langkilde A M, Pfeffer Marc A, Pocock Stuart, Swedberg Karl, Rouleau Jean L, Chaturvedi Nishi, Ivanovich Peter, Levey Andrew S, Christ-Schmidt Heidi, Mann Johannes, Held Claes, Varenhorst Christoph, Holmgren Pernilla, Hallberg Theresa, Douthat Walter, Filho Roberto Pecoits, Cherney David, Hou Fan Fan, Persson Frederik, Haller Hermann, Wittmann István, Tudományegyetem Pécsi, Khullar Dinesh, Naoki Kashihara, Correa-Rotter Richardo, Escudero Elizabeth, Isidto Rey, Iloilo Healthlink, Nowicki Michal, Batiushin Mikhail, Kang Shin-Wook, Teruel José Luis Górriz, Furuland Hans, Bilchenko Oleksandr, Mark Patrick, Dwyer Jamie, Van Bui Pham, "Rationale and protocol of the Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) randomized controlled trial", Nephrology Dialysis Transplantation, GB , (20200201), vol. 35, no. 2, doi:10.1093/ndt/gfz290, ISSN 0931-0509, pages 274 - 282, XP093282731

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