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Dulaglutide For The Treatment Of Chronic Kidney Disease - EP3630164

The patent EP3630164 was granted to ELI Lilly on Aug 23, 2023. The application was originally filed on May 24, 2018 under application number EP18730908A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3630164

ELI LILLY
Application Number
EP18730908A
Filing Date
May 24, 2018
Status
Granted And Under Opposition
Jul 21, 2023
Publication Date
Aug 23, 2023
External Links
Slate, Register, Google Patents

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GENERICS UKMay 23, 2024ELKINGTON AND FIFEADMISSIBLE

Patent Citations (3) New

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

Citation PhasePublication Number
DESCRIPTIONUS2010196405
DESCRIPTIONUS7452966
INTERNATIONAL-SEARCH-REPORTWO2011138421

Non-Patent Literature (NPL) Citations (29) New

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

Citation PhaseReference Text
DESCRIPTION- ADLER et al., UKPDS 64) Kidney International, (20030000), vol. 63, pages 225 - 232
DESCRIPTION- CHEMICAL ABSTRACTS, Database accession no. 923950-08-7
DESCRIPTION- IF.MANN et al., J. Am. Soc. Nephrol. FII-ORDOI, (20160000), vol. 27
DESCRIPTION- LEVEY AS; STEVENS LA, "Estimating GIR using the CKD Epidemiology Collaboration (CKD-EPI) creatinine equation: more accurate GFR estimates, lower CKD prevalence estimates, and better risk predictions", AM. J. KIDNEY DIS., (20100000), vol. 55, no. 4, pages 622 - 627
INTERNATIONAL-SEARCH-REPORT- Anonymous, "A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)", (20120618), URL: https://clinicaltrials.gov/ct2/show/NCT01621178, (20180803), XP055497221 [X] 1-41 * the whole document *
INTERNATIONAL-SEARCH-REPORT- K R TUTTLE ET AL, "Comparable glycaemic control with once weekly dulaglutide versus insulin glargine, both combined with lispro, in type 2 diabetes and chronic kidney disease (AWARD-7)", DIABETOLOGIA, BERLIN, DE, (20170911), vol. 60, no. Suppl. 1, doi:10.1007/s00125-017-4350-z, ISSN 0012-186X, page S3, XP055497178 [XP] 1-41 * the whole document *
INTERNATIONAL-SEARCH-REPORT- KATHERINE R TUTTLE ET AL, "Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial", THE LANCET / DIABETES & ENDOCRINOLOGY, UK, (20180801), vol. 6, no. 8, doi:10.1016/S2213-8587(18)30104-9, ISSN 2213-8587, pages 605 - 617, XP055497169 [T] 1-41 * the whole document *
INTERNATIONAL-SEARCH-REPORT- LILI TONG ET AL, "Glycemic control of type 2 diabetes mellitus across stages of renal impairment: information for primary care providers", POSTGRADUATE MEDICINE., US, (20180519), vol. 130, no. 4, doi:10.1080/00325481.2018.1457397, ISSN 0032-5481, pages 381 - 393, XP055497193 [XP] 1-41 * the whole document *
INTERNATIONAL-SEARCH-REPORT- KATHERINE R. TUTTLE ET AL, "Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials", DIABETES, OBESITY AND METABOLISM, (20161123), vol. 19, no. 3, doi:10.1111/dom.12816, ISSN 1462-8902, pages 436 - 441, XP055497173 [XD] 1-41 * the whole document *
INTERNATIONAL-SEARCH-REPORT- MELANIE DAVIES ET AL, "The treatment of type 2 diabetes in the presence of renal impairment: what we should know about newer therapies", CLINICAL PHARMACOLOGY: ADVANCES AND APPLICATIONS, (20160623), vol. 8, doi:10.2147/CPAA.S82008, pages 61 - 81, XP055497212 [X] 1-41 * the whole document *
OPPOSITION- Anonymous, "Assessment report Trulicity EMA/CHMP/524604/2014", Assessment report Trulicity, European Medicines Agency, pages 1 - 172, Assessment report Trulicity, URL: https://www.ema.europa.eu/en/documents/assessment-report/trulicity-epar-public-assessment-report_en.pdf, XP093308253
OPPOSITION- Anonymous, "A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD) (AWARD-7)", ClinicalTrials.gov; NCT01621178, (20170502), ClinicalTrials.gov; NCT01621178, URL: https://clinicaltrials.gov/study/NCT01621178?tab=history&a=47#version-content-panel, XP093190906
OPPOSITION- Anonymous, "Chronic kidney disease", Health A to Z - Conditions A to Z - Overview - Chronic kidney disease, NHS, UK, UK, pages 1 - 3, Health A to Z - Conditions A to Z - Overview - Chronic kidney disease, URL: https://www.nhs.uk/conditions/kidney-disease/, XP093308260
OPPOSITION- Anonymous, "High Blood Pressure & Kidney Disease - NIDDK", Health Information - Kidney Disease, National Institute of Diabetes and Digestive and Kidney Diseases, pages 1 - 10, Health Information - Kidney Disease , URL: https://www.niddk.nih.gov/health-information/kidney-disease/high-blood-pressure, XP093308257
OPPOSITION- Buffet Leticia, Ricchetti Charlotte, "Chronic Kidney Disease and Hypertension: A Destructive Combination", US Pharmacist, (20120620), XP093190902
OPPOSITION- Tonneijck Lennart; Smits Mark M.; Muskiet Marcel H.; Hoekstra Trynke; Kramer Mark H.; Danser A. H.; Diamant Michaela; Joles Jaap A.; Raalte Daniël H. van, "Acute renal effects of the GLP-1 receptor agonist exenatide in overweight type 2 diabetes patients: a randomised, double-blind, placebo-controlled trial", Diabetologia, Springer Berlin Heidelberg, Berlin/Heidelberg, Berlin/Heidelberg, (20160401), vol. 59, no. 7, doi:10.1007/s00125-016-3938-z, ISSN 0012-186X, pages 1412 - 1421, XP035974425
OPPOSITION- Blonde Lawrence, Jendle Johan, Gross Jorge, Woo Vincent, Jiang Honghua, Fahrbach Jessie L, Milicevic Zvonko, "Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20150501), vol. 385, no. 9982, doi:10.1016/S0140-6736(15)60936-9, ISSN 0140-6736, pages 2057 - 2066, XP093190907
OPPOSITION- Blonde Lawrence, Jendle Johan, Gross Jorge, Woo Vincent, Jiang Honghua, Fahrbach Jessie L, Milicevic Zvonko, "Supplementary appendix: Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study", LANCET, The Lancet Publishing Group, GB, GB , (20150523), vol. 385, no. 9982, doi:10.1016/S0140-6736(15)60936-9, ISSN 1474-547X, pages 1 - 14, XP093308235
OPPOSITION- Katherine R Tuttle, Lakshmanan Mark C, Rayner Brian, Busch Robert S, Zimmermann Alan G, Woodward D Bradley, Botros Fady T, "Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial", The lancet / Diabetes & Endocrinology, Elsevier, UK, UK , (20180801), vol. 6, no. 8, doi:10.1016/S2213-8587(18)30104-9, ISSN 2213-8587, pages 605 - 617, XP055497169
OPPOSITION- Tuttle Katherine R, Lakshmanan Mark C, Rayner Brian, Busch Robert S, Zimmermann Alan G, Woodward D Bradley, Botros Fady T, "Supplementary appendix : Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial", The lancet / Diabetes & Endocrinology, Elsevier, UK, UK , (20180614), vol. 6, no. 8, doi:10.1016/S2213-8587(18)30104-9, ISSN 2213-8587, pages 1 - 18, XP093308250
OPPOSITION- Fujita Hiroki, Morii Tsukasa, Fujishima Hiromi, Sato Takehiro, Shimizu Tatsunori, Hosoba Mihoko, Tsukiyama Katsushi, Narita Takuma, Takahashi Takamune, Drucker Daniel J., Seino Yutaka, Yamada Yuichiro, "The protective roles of GLP-1R signaling in diabetic nephropathy: possible mechanism and therapeutic potential", Kidney International, Elsevier, United States, United States, (20140301), vol. 85, no. 3, doi:10.1038/ki.2013.427, ISSN 0085-2538, pages 579 - 589, XP093190901
OPPOSITION- Anon, "Chapter 1: Definition and classification of CKD", Kidney International Supplements, (20130101), vol. 3, no. 1, doi:10.1038/kisup.2012.64, ISSN 2157-1716, pages 19 - 62, XP093103335
OPPOSITION- Pfeffer Marc A., Claggett Brian, Diaz Rafael, Dickstein Kenneth, Gerstein Hertzel C., Køber Lars V., Lawson Francesca C., Ping Lin, Wei Xiaodan, Lewis Eldrin F., Maggioni Aldo P., Mcmurray John J.V., Probstfield Jeffrey L., Riddle Matthew C., Solomon Scott D., Tardif Jean-Claude, "Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome", New England Journal of Medicine, Massachusetts Medical Society, United States, United States, (20151203), vol. 373, no. 23, doi:10.1056/NEJMoa1509225, ISSN 0028-4793, pages 2247 - 2257, XP093305384
OPPOSITION- Marso Steven P., Bain Stephen C., Consoli Agostino, Eliaschewitz Freddy G., Jódar Esteban, Leiter Lawrence A., Lingvay Ildiko, Rosenstock Julio, Seufert Jochen, Warren Mark L., Woo Vincent, Hansen Oluf, Holst Anders G., Pettersson Jonas, Vilsbøll Tina, "Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes", The new England journal of medicine, Eli Lily and Company, USA, USA, (20161110), vol. 375, no. 19, doi:10.1056/NEJMoa1607141, pages 1834 - 1844, XP093097921
OPPOSITION- Katherine R. Tuttle; T. Dwight McKinney; Jaime A. Davidson; Greg Anglin; Kristine D. Harper; Fady T. Botros, "Effects of once‐weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20161124), vol. 19, no. 3, doi:10.1111/dom.12816, ISSN 1462-8902, pages 436 - 441, XP072207562
OPPOSITION- Tuttle Katherine R., T. Dwight Mckinney, Jaime A. Davidson, Greg Anglin, Kristine D. Harper, Fady T. Botros, "Supplementary Appendix: Effects of once-weekly dulaglutide on kidney function in patients with type 2 diabetes in phase II and III clinical trials", Diabetes, Obesity and Metabolism, Blackwell Science, GB, GB , (20170301), vol. 19, no. 3, doi:10.1111/dom.12816, ISSN 1462-8902, pages 1 - 10, XP093308226
OPPOSITION- Ferdinand Keith C., Dunn Julia, Nicolay Claudia, Sam Flora, Blue Emily K., Wang Hui, "Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes", Cardiovasc Diabetology, BIOMED CENTRAL, LONDON, GB, GB , (20230309), vol. 22, no. 1, doi:10.1186/s12933-023-01775-x, ISSN 1475-2840, pages 49 - 11, XP093308239
OPPOSITION- Shigeki Imamura, Keiji Hirai, Aizan Hirai, "The Glucagon-Like Peptide-1 Receptor Agonist, Liraglutide, Attenuates the Progression of Overt Diabetic Nephropathy in Type 2 Diabetic Patients", TOHOKU JOURNAL OF EXPERIMENTAL MEDICINE., TOHOKU UNIVERSITY MEDICAL PRESS, SENDAI., JP, JP , (20130101), vol. 231, no. 1, doi:10.1620/tjem.231.57, ISSN 0040-8727, pages 57 - 61, XP055291015
OPPOSITION- Melanie Davies et al., "The treatment of type 2 diabetes in the presence of renal impairment: what we should know about newer therapies", Clinical Pharmacology: Advances and Applications, (2016), vol. 8, doi:10.2147/CPAA.S82008, XP055497212

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