US 6268343B1
· Knudsen et al.
· 2001
[cited by applicant]
US 7799344B2
· Oberg
· 2010
[cited by applicant]
US 8114833B2
· Pedersen et al.
· 2012
[cited by applicant]
US 8129343B2
· Lau et al.
· 2012
[cited by applicant]
US 8536122B2
· Lau et al.
· 2013
[cited by applicant]
US 8748376B2
· Ludvigsen et al.
· 2014
[cited by applicant]
US 8846618B2
· Flink et al.
· 2014
[cited by applicant]
US 9764003B2
· Jensen
· 2017
[cited by applicant]
US 20070203058A1
· Lau et al.
· 2007
[cited by applicant]
US 20100047762A1
· Button et al.
· 2010
[cited by applicant]
US 20100292133A1
· Spetzler et al.
· 2010
[cited by applicant]
US 20150232527A1
· Gong et al.
· 2015
[cited by applicant]
US 20160108102A1
· Lau et al.
· 2016
[cited by applicant]
US 20190231876A1
· Pedersen et al.
· 2019
[cited by applicant]
US 20240316159A1
· Groenning et al.
· 2024
[cited by applicant]
BR PI0721213A2
· 2014
[cited by applicant]
BR 112014032905A2
· 2017
[cited by applicant]
BR 112014004879B1
· 2020
[cited by applicant]
CN 102229668A
· 2011
[cited by applicant]
CN 104519902A
· 2015
[cited by applicant]
CN 108129565A
· 2018
[cited by applicant]
RU 2409349C2
· 2011
[cited by applicant]
RU 2413530C2
· 2011
[cited by applicant]
WO 2005027978A2
· 2005
[cited by applicant]
WO 2005049061A2
· 2005
[cited by applicant]
WO 2006097537A2
· 2006
[cited by applicant]
WO 2010092163A2
· 2010
[cited by applicant]
WO 2011080103A1
· 2011
[cited by applicant]
WO 2011138421A1
· 2011
[cited by applicant]
WO 12016419A1
· 2012
[cited by applicant]
WO 2012080471A1
· 2012
[cited by applicant]
WO 2012088379A2
· 2012
[cited by applicant]
WO 2012107476A1
· 2012
[cited by applicant]
WO 12130136A1
· 2012
[cited by applicant]
WO 2012136790A1
· 2012
[cited by applicant]
WO 2012177929A2
· 2012
[cited by applicant]
WO 2014005858A1
· 2014
[cited by applicant]
WO WO2014177683A1
· 2014
[cited by examiner]
WO 2017112824
· 2017
[cited by applicant]
Saxenda, Full Prescribing Information, Sep. 2016, 28 pages.
[cited by applicant]
U.S. Appl. No. 62/541,260, filed Aug. 4, 2017, 98 pages.
[cited by applicant]
Ahrén et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Sitagliptin as an Add-on to Metformin, Thiazolidinediones, or Both, in Patients with Type 2 Diabetes (SUSTAIN 2): A 56-Week Double-Blind, P…
[cited by applicant]
Bhansali et al., “Historical Overview of Incretin Based Therapies”, Journal of Association of Physicians of India, Jun. 2010, vol. 58, pp. 10-14.
[cited by applicant]
Carracher et al., “American Association of Diabetes Educators 2017”, Journal of Diabetes, Aug. 2017, pp. 1054-1057.
[cited by applicant]
Davies et al., “Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes the Scale Diabetes Randomized Clinical Trial”, Journal of the American Medical Association, Aug. 2015, vol. 314, No. 7, pp. 687…
[cited by applicant]
Drucker et al., “The Incretin System: Glucagon-Like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors in Type 2 Diabetes”, Lancet, Nov. 2006, vol. 368, pp. 1696-1705.
[cited by applicant]
Holst et al., “Glucagon-Like Peptide 1 and Inhibitors of Dipeptidyl Peptidase IV in the Treatment of Type 2 Diabetes Mellitus”, Current Opinion in Pharmacology, Oct. 2004, vol. 4, pp. 589-596.
[cited by applicant]
Jensen et al., “Absorption, Metabolism and Excretion of the GLP-1 Analogue Semaglutide in Humans and Nonclinical Species”, European Journal of Pharmaceutical Sciences, Mar. 2017, vol. 104, pp. 31-41.
[cited by applicant]
Kalra et al., “Glucagon-like Peptide-1 Receptor Agonists in the Treatment of Type 2 Diabetes: Past, Present, and Future”, Indian Journal of Endocrinology & Metabolism, Mar.-Apr. 2016, vol. 20, No. 2, pp. 254-267.
[cited by applicant]
Kapitza et al., “Safety, Tolerability, Pharmacokinetics (PK) / Pharmacodynamics (PD) of Single Escalating Doses of Semaglutide, A Unique Once Weekly GLP-1 Analogue, in Healthy Male Subjects”, Diabetologia, 2012, vol. 55…
[cited by applicant]
Lund et al., “Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Type 2 Diabetes: Differences and Similarities”, European Journal of Internal Medicine, Mar. 2014, vol. 25, pp. 407-414.
[cited by applicant]
Marso et al., “Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes”, The New England Journal of Medicine, Sep. 16, 2016, vol. 375, No. 19, pp. 1834-1844.
[cited by applicant]
Monami et al., “Effects of Glucagon-Like Peptide-1 Receptor Agonists on Body Weight: A Meta-Analysis”, Experimental Diabetes Research, 2012, pp. 1-8.
[cited by applicant]
Nauck et al., “Incretin-Based Therapies”, Diabetes Care, Nov. 2009, vol. 32, Supplement 2, pp. S223- S231.
[cited by applicant]
NCT01272232, “Effect of Liraglutide on Body Weight in Overweight or Obese Subjects with Type 2 Diabetes: SCALE™—Diabetes”, May 2011, 4 pages.
[cited by applicant]
NCT03144271, “Dose Escalation Trial of Single Subcutaneous Doses of NNC 0113-0217 to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Male Subjects”, May 2017, 9 pages.
[cited by applicant]
NCT02461589, “Dose-finding of Semaglutide Administered Subcutaneously Once Daily Versus Placebo and Liraglutide in Subjects With Type 2 Diabetes”, Oct. 2017, 11 pages.
[cited by applicant]
Novo Nordisk 2016 Form 6-K, Feb. 9, 2017, 124 pages.
[cited by applicant]
Novo Nordisk Press Release, “Novo Nordisk reports up to 13.8% weight loss in people with obesity receiving semaglutide in phase 2 trial”, Jun. 23, 2017, 2 pages.
[cited by applicant]
Novo Nordisk, “Investor Presentation—First 6 months of 2017”, 2017, 110 pages.
[cited by applicant]
Novo Nordisk R&D Pipeline, “Semaglutide”, 2010, 3 pages.
[cited by applicant]
Ozempic Label, Highlights of Prescribing Information, Nov. 2024.
[cited by applicant]
Peterson et al., “Glucose Dysregulation and Response to Common Anti-diabetic Agents in the FATZO/Pco Mouse”, PLOS ONE, Jun. 2017, pp. 1-19.
[cited by applicant]
Pi-Sunyer et al., “A Randomized, Controlled Trial of 3.0 mg of Liraglutide in Weight Management”, New England Journal of Medicine, Jul. 2015, vol. 373, No. 1, pp. 11-22.
[cited by applicant]
Smith, “Summary Review for Regulatory Action-Saxenda”, Center for Drug Evaluation and Research, Nov. 2014, pp. 1-37.
[cited by applicant]
Sorli et al., “Efficacy and Safety of Once-Weekly Semaglutide Monotherapy Versus Placebo in Patients with Type 2 Diabetes (Sustain 1): A Double-Blind, Randomised, Placebo-Controlled, Parallel-Group, Multinational, Multi…
[cited by applicant]
Victoza Label, Highlights of Prescribing Information, Jan. 2010.
[cited by applicant]
Vilsboll et al., “Liraglutide, a Long-Acting Human Glucagon-Like Peptide-1 Analog, Given as Monotherapy Significantly Improves Glycemic Control and Lowers Body Weight Without Risk of Hypoglycemia in Patients with Type 2…
[cited by applicant]
Bode et al., “10-Fold Liraglutide Overdose Over 7 Months Resulted Only in Minor Side-Effects”, Journal of Clinical Pharmacology, 2013, vol. 53, No. 7, pp. 785-786.
[cited by applicant]
Davies et al., “Supplemental Online Content, Efficacy of Liraglutide for Weight Loss Among Patients with Type 2 Diabetes the Scale Diabetes Randomized Clinical Trial”, Journal of the American Medical Association, 2015, …
[cited by applicant]
Drugs at FDA Adlyxin, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208471, 2 pages.
[cited by applicant]
Drugs at FDA Byduryeon, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022200, 3 pages.
[cited by applicant]
Drugs at FDA Ozempic, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209637, 2 pages.
[cited by applicant]
Drugs at FDA Saxenda, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=206321, 3 pages.
[cited by applicant]
Drugs at FDA Tanzeum, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125431, 2 pages.
[cited by applicant]
Drugs at FDA Trulicity, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=125469, 3 pages.
[cited by applicant]
Drugs at FDA Victoza, retrieved on Nov. 5, 2024 from: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=022341, 4 pages.
[cited by applicant]
Elmehdawi et al., “An Accidental Liraglutide Overdose: Case Report”, Libyan Journal of Medicine, 2014, vol. 9, p. 1.
[cited by applicant]
Jimenez-Solem et al., “Dulaglutide, a Long-Acting GLP-1 Analog Fused with an Fc Antibody Fragment for the Potential Treatment of Type 2 Diabetes”, Current Opinion in Molecular Therapeutics, 2010, vol. 12, No. 6, pp. 790…
[cited by applicant]
Nakanishi et al., “Attempted Suicide with Liraglutide Overdose Did Not Induce Hypoglycemia”, Diabetes Research & Clinical Practice, Nov. 2012, vol. 99, p. e3-e4.
[cited by applicant]
Novo Nordisk, “Investor presentation First 9 months of 2016”, 2016, 113 pages.
[cited by applicant]
American Diabetes Association, “Standards of Medical Care in Diabetes”, Diabetes Care, Jan. 2004, vol. 27, Supplement 1, pp. S15-S35.
[cited by applicant]
American Diabetes Association, “Standards of Medical Care in Diabetes”, Diabetes Care, Jan. 2010, vol. 33, Supplement 1, pp. S11-S61.
[cited by applicant]
UK Prospective Diabetes Study (UKPDS) Group, “Effect of Intensive Blood-Glucose Control with Metformin on Complications in Overweight Patients with Type 2 Diabetes (UKPDS 34)”, Lancet, Sep. 1998, vol. 352, pp. 854-865.
[cited by applicant]
Victoza Label, Highlights of Prescribing Information, Aug. 2017.
[cited by applicant]
Ahmann et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER after 56 Weeks in Subjects with Type 2 Diabetes (Sustain 3),” Diabetes Research and Clinical Practice, 2016, vol. 120, page S51.
[cited by applicant]
Anonymous: “NCT02453711 on Jul. 26, 2017: ClinicalTrials.gov Archive,” Retrieved from Internet: URL:https://clincialtrials.gov/archive/NCT02453711/2017_07_26, retrieved on Jan. 26, 2018.
[cited by applicant]
Aroda et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Once-Daily Insulin Glargine in Insulin-Naive Subjects with Type 2 Diabetes (Sustain 4),” Diabetes Research and Clinical Practice, 2016, vol. 120, p. S…
[cited by applicant]
Blundell et al., “Effects of once-weekly Semaglutide on appetite, energy intake, control of eating, food preference and body weight in subjects with obesity,” Diabetes Obes Metab, 2017, vol. 19, pp. 1242-1251.
[cited by applicant]
Chow et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Sitagliptin as Add-On to Metformin and/or Thiazolidinediones in Subjects with T2D (Sustain 2),” Diabetes Research and Clinical Practice, 2016, vol. 120…
[cited by applicant]
Davies et al., “Dose-dependent glucose lowering and body weight reductions with the novel oral formulation of semaglutide in patients with early type 2 diabetes,” Abstract 149, Diabetologia, 2016, vol. 59, Suppl. 1, p. …
[cited by applicant]
Davies et al., “Effect of oral semaglutide compared with placebo and subcutaneous semaglutide on glycemic control in patients with type 2 diabetes,” JAMA, 2017, vol. 218, No. 15, pp. 1460-1470.
[cited by applicant]
Lingvay et al., “Treatment with semaglutide provides superior body weight reduction vs comparators in subjects with type 2 diabetes across the Sustain 1-5 trials,” Abstract 817, Diabetologia, 2017, vol. 60, Suppl. 1, p.…
[cited by applicant]
Nauck et al., “The once-weekly human GLP-1 analogue semaglutide provides significant reductions in HbA1c and body weight in patients with type 2 diabetes,” Abstract 2, Diabetologia, 2012, vol. 55, Suppl. 1, p. S7.
[cited by applicant]
Tan et al., “Efficacy and safety of once-weekly semaglutide for the treatment of type 2 diabetes,” Expert Opin Investig Drugs, 2017, vol. 26, No. 9, pp. 1083-1089.
[cited by applicant]
Nauck et al. “A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes.” Diabetes care, Feb. 2…
[cited by applicant]
O'Neil et al. “Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.” …
[cited by applicant]
Madsbad S. et al. An Overview of once-weekly glucagon-like peptide-1 receptor agonists available efficacy and safety data and perspectives for the future, 'Diabetes, Obesity and Metabolism Year 2011, vol. 13, No. 5, pp.…
[cited by applicant]
Buse B. J et al., Exenatide once weekly versus liraglutide once daily in patients with type 2 diabetes (Duration-6): a randomised, open-label study, Lancet, 2013, vol. 381, pp. 117-124.
[cited by applicant]
Kim et al. “Effects of Once-Weekly Dosing of a Long-Acting Release Formulation of Exentide on Glucose Control and Body Weight in Subjects with Type 2 Diabetes.” Diabetes care (2007) vol. 30 pp. 1487-1493.
[cited by applicant]
Bydureon Nda 022200/S-008 Package Information pp. 1-179 (Feb. 2014).
[cited by applicant]
Clinical Trial NCT00696657 entitled “A Randomized Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide.” pp. Mar. 1-5, 2015. Accessed Sep. 24, 2015 at clinicaltrials.gov/archive/…
[cited by applicant]
Lau et al. “Discovery of the Once-WEekly Glucagon-Like Peptide-1 (GLP-1) Analogue Semaglutide.” J. Med. Chem. (2015) vol. 58 pp. 7370-7380.
[cited by applicant]
Eperzan Assessment Report. Euro. Med. Agency. pp. 1-124 (2014) accessed Sep. 24, 2015 at URL ema.europa.ed/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002735/WC500165119.pdf.
[cited by applicant]
Trulicity Assessment Report. Euro. Med. Agency. pp. 1-172 (2014) accessed Sep. 24, 2015 at URL ema.europa.ed/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002825/WC500179473.pdf.
[cited by applicant]
Mizuta et al. “The Role for GLP-1 in Regulation of Body Weight.” Progress in Medicine 2008 vol. 28 No 8 pp. 1909-1912.
[cited by applicant]
CDC, “National Health and Nutrition Examination Survey: Healthy Weight, Overweight and Obesity among U.S. adults” 03-0260 pp. 1-2 (Jul. 2003), accessed May 10, 2016 at URL cdc.gov/nchs/data/nhanes/databriefs/adultweight…
[cited by applicant]
Application No. EP12/186,781, filed Oct. 1, 2012.
[cited by applicant]
Application No. EP12174535, filed Jul. 1, 2012.
[cited by applicant]
U.S. Appl. No. 61/694,837, filed Aug. 30, 2012.
[cited by applicant]
U.S. Appl. No. 61/708,162, filed Oct. 1, 2012.
[cited by applicant]
Astrup et al., “Effects of liraglutide in the treatment of obesity: a randomised, double-blind, placebo-controlled study.” Lancet, Nov. 2009, vol. 374, No. 9701, pp. 1606-1616.
[cited by applicant]
Astrup et al., “Safety, tolerability and sustained weight loss over 2 years with the once-daily human GLP-1 analog, liraglutide.” Int J Obes (Lond). Jun. 2012, vol. 36, No. 6, pp. 843-854.
[cited by applicant]
Barnett et al., “Obesity and Diabetes”, John Wiley & Sons, Mar. 12, 2009, pp. 87-101.
[cited by applicant]
Cleland et al., Formulation and Delivery of Proteins and Peptides, vol. 567, Aug. 1994, Chapter 1, p. 5.
[cited by applicant]
Clinical trial: NCT00422058 “The Effect of Liraglutide on Body Weight in Obese Subjects 11 Without Diabetes” Jan. 2007, 1 Page.
[cited by applicant]
European Medicines Agency EPAR Assessment Report for Victoza, Liraglutide , 2009, p. 7 and p. 9.
[cited by applicant]
Examination Division Exam Dec. 12, 2006.
[cited by applicant]
Frokjaer et al., “Pharmaceutical formulation development of peptides and proteins”, Jan. 2003, Chapter 8, p. 147.
[cited by applicant]
Full prosecution file of the opposed patent EP2866825B1 that can be found in European Patent register https://register.epo.org/applicationlng=en&tab=doclist&number=EP13737808&filter=ALL Accessed Jan. 25, 2021.
[cited by applicant]
Gibson, M., “Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection in Commercial Dosage Form”, Drugs and the Pharmaceutical Sciences, Informa Healthcare, 2009, vol. 199, p. 327.
[cited by applicant]
History of Changes for Study NCT00696657, ClinicalTrials.gov archive, Mar. 3, 2011.
[cited by applicant]
Novo Nordisk announcement Semaglutide 2.4mg for obesity 2020, “Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management” Dec. 4, 2020.
[cited by applicant]
Novo Nordisk Clinical trial report: NN8022-I 807 “Effect of Liraglutide on Body Weight in Obese Subjects Without Diabetes” Feb. 8, 2010 p. 34.
[cited by applicant]
Torekov et al., “Obesity-an indication for GLP-1 treatment?” Obesity pathophysiology and GIP-1 treatment potential, Obes Rev, Aug. 2011, vol. 12, No. 8, pp. 593-601.
[cited by applicant]
European Medicines Agency EPAR Ozempic, Semaglutide, Assessment Report, 2018 p. 11 and p. 21.
[cited by applicant]
Protocol of clinical trial NCT00696657 entitled A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide: Sep. 22, 2011, ClinicalTrials.gov archive, pp. 1-5.
[cited by applicant]
Yakushinyaku, “General Consideration for Clinical Evaluations of New Drugs”, Jun. 29, 1992, pp. 1-12.
[cited by applicant]
Kapitza et al., “Semaglutide, a Once-Weekly Human GLP-1 Analog, Does Not Reduce the Bioavailability of the Combined Oral Contraceptive, Ethinylestradiol/Levonorgestrel,” J Clin Pharmacol., May 2015, vol. 55, No. 5, pp. …
[cited by applicant]
Holst JJ., “The physiology of glucagon-like peptide 1,” Physiol Rev, Oct. 2007, vol. 87, No. 4, pp. 1409-1439.
[cited by applicant]
Lovshin et al., “Incretin-based therapies for type 2 diabetes mellitus”, Nature Reviews Endocrinology, May 2009, vol. 5, pp. 262-269.
[cited by applicant]
Baggio et al., “Biology of Incretins: GLP-1 and GIP,” Gastroenterology, 2007, vol. 132, pp. 2131-2157.
[cited by applicant]
Ahmann et al., “Efficacy and Safety of Once-Weekly Semaglutide Versus Exenatide ER in Subjects With Type 2 Diabetes (Sustain 3): A 56-Week, Open-Label, Randomized Clinical Trial”, Diabetes Care, Dec. 2017, vol. 41, No. …
[cited by applicant]
Aroda et al., “Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (Sustain 4): a rando…
[cited by applicant]
Li Jun et al., “Peoples Medical Publishing House” Clinical pharmacology 4th Edition, Jun. 2008, pp. 31, 48-49.
[cited by applicant]
ClinicalTrials.gov—NCT02453711, “Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus”, published on Oct. 1, 2015, updated Apr. 17, 2020, and available at https://cl…
[cited by applicant]
Strathe et al., “A model-based approach to predict individual weight loss with semaglutide in people with overweight or obesity” Diabetes Obesity and Metabolism, Jul. 2023, vol. 25, No. 11, pp. 3171-3180.
[cited by applicant]
Clinical Trial NCT00696657 entitled “A Randomized Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide”, ClinicalTrials.gov, Aug. 14, 2019, available and accessed on https://clin…
[cited by applicant]