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Solid Compositions Comprising A Glp-1 Agonist, A Salt Of N-(8-(2-Hydroxybenzoyl)Amino)Caprylic Acid And A Lubricant - EP3746111

The patent EP3746111 was granted to Novo Nordisk on Jul 19, 2023. The application was originally filed on Feb 1, 2019 under application number EP19702275A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3746111

NOVO NORDISK
Application Number
EP19702275A
Filing Date
Feb 1, 2019
Status
Granted And Under Opposition
Jun 16, 2023
Grant Date
Jul 19, 2023
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (5)

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HEXALApr 19, 2024MAIWALDADMISSIBLE
HOEFER & PARTNER PATENTANWALTE MBBApr 18, 2024HOEFER & PARTNER PATENTANWALTE MBBADMISSIBLE
KRAUS & LEDERER PARTGMBBApr 18, 2024KRAUS & LEDERER PARTGMBBADMISSIBLE
ACAPOApr 17, 2024ACAPOADMISSIBLE
ACAPO ONSAGERSApr 17, 2024ACAPOADMISSIBLE

Patent Citations (50) New

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

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Non-Patent Literature (NPL) Citations (30) 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
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OPPOSITION- Voigt Rudolf, Bornschein Manfred, "Granulierung. ", Lehrbuch der pharmazeutischen Technologie, Fünfte, völlig überarbeitete Auflage, Vertag Chemie, (19840101), pages 156-158, 162, 178-179 - 645-646, 659-660, XP093187235-
OPPOSITION- MELANIE DAVIES, "Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes : A Randomized Clinical Trial", THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, (20171017), vol. 318, doi:10.1001/jama.2017.14752, XP055492106
OPPOSITION- Melanie Davies et al, "Effect of Oral Semaglutide Compared With Placebo and Subcutaneous Semaglutide on Glycemic Control in Patients With Type 2 Diabetes : A Randomized Clinical Trial", JAMA, American Medical Association, Chicago, IL, Chicago, IL, (20171017), vol. 318, no. 15, doi:10.1001/jama.2017.14752, ISSN 0098-7484, pages 1460 - 1470, XP055492106
OPPOSITION- Bækdal Tine A., Thomsen Mette, Kupčová Viera, Hansen Cilie W., Anderson Thomas W., "Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20181001), vol. 58, no. 10, doi:10.1002/jcph.1131, ISSN 0091-2700, pages 1314 - 1323, XP093187856
OPPOSITION- Charlotte Granhall, Flemming L. Søndergaard, Mette Thomsen, Thomas W. Anderson, "Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects with Renal Impairment", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20180406), vol. 57, doi:10.1007/s40262-018-0649-2, ISSN 0312-5963, XP055491944
OPPOSITION- Charlotte Granhall, Morten Donsmark, Thalia M. Blicher, Georg Golor, Flemming L. Søndergaard, Mette Thomsen, Tine A. Bækdal, "Safety and Pharmacokinetics of Single and Multiple Ascending Doses of the Novel Oral Human GLP-1 Analogue, Oral Semaglutide, in Healthy Subjects and Subjects with Type 2 Diabetes", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20190601), vol. 58, no. 6, doi:10.1007/s40262-018-0728-4, ISSN 0312-5963, XP055545538
OPPOSITION- Edmonds David J., Price David A., "Oral GLP-1 Modulators for the Treatment of Diabetes", Edmonds David J., Price David A., D. M. Bailey and D. M. Bailey, ANNUAL REPORTS IN MEDICINAL CHEMISTRY, US , Academic Press , (20130101), vol. 48, pages 119 - 130, doi:10.1016/B978-0-12-417150-3.00009-0, ISSN 0065-7743, XP093187861
OPPOSITION- Maher Sam; Mrsny Randall J.; Brayden David J., "Intestinal permeation enhancers for oral peptide delivery", Advanced Drug Delivery Reviews, Elsevier, Amsterdam , NL, Amsterdam , NL , (20160616), vol. 106, doi:10.1016/j.addr.2016.06.005, ISSN 0169-409X, pages 277 - 319, XP029810692
OPPOSITION- Drucker Daniel J., "Mechanisms of Action and Therapeutic Application of Glucagon-like Peptide-1", Cell Metabolism, Cell Press, United States, United States , (20180401), vol. 27, no. 4, doi:10.1016/j.cmet.2018.03.001, ISSN 1550-4131, pages 740 - 756, XP093187858
OPPOSITION- D Dahlgren, "Intestinal absorption-modifying excipients: A current update on preclinical in vivo evaluations", European Journal of Pharmaceutics and Biopharmaceutics , (20190712), vol. 142, doi:10.1016/j.ejpb.2019.07.013, XP085764869
OPPOSITION- R.E. STEINERT et al, "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20091201), vol. 86, no. 6, doi:10.1038/clpt.2009.159, ISSN 0009-9236, pages 644 - 650, XP002635568
OPPOSITION- Daniel Drucker, "Advances in oral peptide therapeutics", Nature Reviews Drug Discovery , (20191217), vol. 19, doi:10.1038/s41573-019-0053-0, XP037082922
OPPOSITION- M. Kidron et al, "A novel per‐oral insulin formulation: proof of concept study in non‐diabetic subjects", DIABETIC MEDICINE., JOHN WILEY & SONS, LTD., GB, GB , (20040322), vol. 21, no. 4, doi:10.1111/j.1464-5491.2004.01160.x, ISSN 0742-3071, pages 354 - 357, XP071684198
OPPOSITION- S Buckley et al, "Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist", Sci. Transl. Med, (20181114), vol. 10, no. 14, doi:10.1126/scitranslmed.aar7047, pages 1 - 13, XP055655030
OPPOSITION- Stephen Buckley, "Transcellular stomach absorption of a derivatized glucagon-like peptide-1 receptor agonist", Sci. Transl. Med., (20181114), vol. 10, doi:10.1126/scitranslmed.aar7047, XP055655030
OPPOSITION- Francisca Araújo et al, "Oral Delivery of Glucagon-like Peptide-1 and Analogs: Alternatives for Diabetes Control?", Journal of Diabetes Science and Technology, Diabetes Technology Society, US, US , (20121101), vol. 6, no. 6, doi:10.1177/193229681200600630, ISSN 1932-2968, pages 1486 - 1497, XP055629598
OPPOSITION- Bruce J. Aungst, "Absorption Enhancers: Applications and Advances", AAPS JOURNAL, AMERICAN ASSOCIATION OF PHARMACEUTICAL SCIENTISTS, US, US , (20111122), vol. 14, no. 1, doi:10.1208/s12248-011-9307-4, ISSN 1550-7416, pages 10 - 18, XP035016737
OPPOSITION- Garett Morin, "The Effect of Lubricants on Powder Flowability for Pharmaceutical Application", AAPS PharmSciTech, (201309), vol. 14, doi:10.1208/s12249-013-0007-5, XP055896275
OPPOSITION- Lotte Bjerre Knudsen, Lau Jesper, "The Discovery and Development of Liraglutide and Semaglutide", Frontiers in Endocrinology, (20190412), vol. 10, doi:10.3389/fendo.2019.00155, pages 1 - 32, XP055658646
OPPOSITION- Li Ying, Yang Dandan, Zhu Chunyan, "Impact of Sodium N-[8-(2-Hydroxybenzoyl)amino]-caprylate on Intestinal Permeability for Notoginsenoside R1 and Salvianolic Acids in Caco-2 Cells Transport and Rat Pharmacokinetics", Molecules, SPRINGER VERLAG, BERLIN, DE, DE , (20181101), vol. 23, no. 11, doi:10.3390/molecules23112990, ISSN 1433-1373, page 2990, XP093187854
OPPOSITION- Caroline Twarog, Sarinj Fattah, Joanne Heade, Sam Maher, Elias Fattal, David J. Brayden, "Intestinal Permeation Enhancers for Oral Delivery of Macromolecules: A Comparison between Salcaprozate Sodium (SNAC) and Sodium Caprate (C10)", Pharmaceutics, (20190213), vol. 11, no. 2, doi:10.3390/pharmaceutics11020078, page 78, XP055634457
OPPOSITION- STEINERT ROBERT E, ET AL, "Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects.", American Journal of Clinical Nutrition, Elsevier, (20101001), vol. 92, no. 4, doi:10.3945/ajcn.2010.29663, ISSN 0002-9165, pages 810 - 817, XP002677085
OPPOSITION- Steinert Robert E, Poller Birk, Castelli M Cristina, Drewe Juergen, Beglinger Christoph, "Oral administration of glucagon-like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects", American Journal of Clinical Nutrition, Elsevier, (20101001), vol. 92, no. 4, doi:10.3945/ajcn.2010.29663, ISSN 0002-9165, pages 810 - 817, XP002797377

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