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Compositions Comprising A Delivery Agent And Preparation Thereof - EP2827845

The patent EP2827845 was granted to Novo Nordisk on Dec 26, 2018. The application was originally filed on Mar 15, 2013 under application number EP13709232A. The patent is currently recorded with a legal status of "Revoked".

EP2827845

NOVO NORDISK
Application Number
EP13709232A
Filing Date
Mar 15, 2013
Status
Revoked
Oct 3, 2024
Publication Date
Dec 26, 2018
External Links
Slate, Register, Google Patents

Patent Summary

Patent Family

Patent Family

Patent Oppositions (5)

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CMS CAMERON MCKENNA NABARRO OLSWANGSep 26, 2019-ADMISSIBLE
GALENICUM HEALTH SLUSep 26, 2019GALENICUM HEALTH SLUADMISSIBLE
GENERICS UKSep 26, 2019TER MEER STEINMEISTER & PARTNERADMISSIBLE
HEXALSep 26, 2019MAIWALDADMISSIBLE
TEVA PHARMACEUTICALSSep 24, 2019VON KAUFFMANNADMISSIBLE

Patent Citations (14) New

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

Citation PhasePublication Number
INTERNATIONAL-SEARCH-REPORTUS2009124639
INTERNATIONAL-SEARCH-REPORTWO2005107773
OPPOSITIONEP2827845
OPPOSITIONNZ219575
OPPOSITIONUS2009124639
OPPOSITIONUS2010069410
OPPOSITIONWO0124777
OPPOSITIONWO03063838
OPPOSITIONWO2005099672
OPPOSITIONWO2005107773
OPPOSITIONWO2006124047
OPPOSITIONWO2009059188
OPPOSITIONWO2012080471
OPPOSITIONWO2013189988

Non-Patent Literature (NPL) Citations (39) 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
INTERNATIONAL-SEARCH-REPORT- XIAORONG HE ET AL, "Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength", JOURNAL OF PHARMACEUTICAL SCIENCES, (20070501), vol. 96, no. 5, doi:10.1002/jps.20938, ISSN 0022-3549, pages 1342 - 1355, XP055060697 [Y] 8 * the whole document *
INTERNATIONAL-SEARCH-REPORT- STEINERT R E 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, vol. 86, no. 6, doi:10.1038/CLPT.2009.159, ISSN 0009-9236, (20091201), pages 644 - 650, (20090902), XP002635568 [Y] 6,7 * the whole document *
OPPOSITION- "Chapter 12: Use of Nonactive Pharmaceutical Excipients in Oral Drug Formulations: Biopharmaceutical Classification System Considerations", Katdare A, Chaubal Mahesh et al, Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems, CRC Press, (20060000), pages 181 - 195, XP055634452
OPPOSITION- "chapter 2 ,8 and 9", parikh dilip m, THE HANDBOOK OF PHARMACEUTICAL GRANULATION TECHNOLOGy, (20100000), vol. 198, page 7-58,163-203, XP055634990
OPPOSITION- "Chapter 45: Oral solid dosage forms", Remington J., Remington: The Science and Practice of Pharmacy. 22nd ed., PhP, (20120000), page 947, XP055634446
OPPOSITION- C. M. KECK et al., "Moderne Pharmazeutische Technologie - Lehbuch fur Studierende", Delivery Systeme fur die perorale Applikation van Peptiden, (20090000), XP055634978
OPPOSITION- "Compression-coated and layer Tablets", LIEBERMAN H. A. et al., Pharmaceutical Dosage Forms: Tablets, MARCEL DEKKER, (19890000), pages 247 - 284, XP055634146
OPPOSITION- "Current Granulation Techniques and Research", Parikh D. M., Handbook of Pharmaceutical Granulation Technology 3rd ed., informa healthcare, (20100000), pages 2 - 3, ISBN 978-1-4398-0789-7, XP055635095
OPPOSITION- Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, Taylor & Francis Group, (20050000), pages 1 - 6, XP055435065
OPPOSITION- "Effect of lubricants", Mary E Mohr et al, Remington, The Science and Practice of Pharmacy, Lippincott Williams & Wilkins, (20050000), pages 677, 892 - 893, 896, 1040, ISBN 978-0-7817-4673-6, XP055635101
OPPOSITION- "History of changes for clinical trial NCT01037582", ClinicalTrials.gov archive, (20110317), URL: https://clinicaltrials.gov/ct2/history/NCT01037582?A=5&B=5&C=merged#StudyPageTop, XP055635512
OPPOSITION- KUSHER IV et al., "Scale-up model describing the impact of lubrication on tablet tensile strength", International Journal of Pharmaceutics, (20100000), vol. 399, no. 1-2, pages 19 - 30, XP027298450
OPPOSITION- LEVIN, "A Collaborative Search for Efficient Methods of Ensuring Unchanged Product Quality and Performance During Scale-Up of Immediate-Release Solid Oral Dosage Forms", LEVIN, LEVIN M., Pharmaceutical Process Scale-Up, MARCEL DEKKER, (20020000), pages 325 - 352, ISBN 978-0-8247-0625-0, XP055634150
OPPOSITION- "Mixing with lubricant", Jack Zheng, Formulation and analytical development for low-dose oral drug products, Wiley, (20090000), page 194, ISBN 978-0-470-05609-7, XP055635091
OPPOSITION- M. KIDRON et al., "A novel per-oral insulin formulation: proof of concept study in non-diabetic subjects", Diabetic Medicine, (20040000), vol. 21, no. 4, pages 354 - 357, XP055520543
OPPOSITION- "Oral Solid Dosage Forms", Ahmed Adel Sakr, Remington, The Science and Practice of Pharmacy, Philadelphia College of Pharmacy, page 947, 958, XP055635508
OPPOSITION- Raymond C Rowe et al., Handbook of Pharmaceutical Excipients, (19960000), pages 404 - 407; 651-653, XP055635485
OPPOSITION- Remington, Essentials of Pharmaceutics, (20130000), XP055634446
OPPOSITION- "Sodium Lauryl Sulphate", Rowe R. C. et al, Handbook of Pharmaceutical excipients, PhP, (20090000), pages 651 - 653, ISBN 978-0-85369-792-3, XP055629883
OPPOSITION- "Valtrex 500mg Tablets", Medicines.org, (15122011), pages 1 - 10, XP055634995
OPPOSITION- "Valtrex® prescribing information", GlaxoSmithKline, (20071000), pages 1 - 20, XP055635480
OPPOSITION- WHO, "International Nonproprietary Names for Pharmaceutical Substances (INN}", WHO Drug Information, (20090000), vol. 23, pages 129 - 130, XP055634142
OPPOSITION- HE et al., "Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength", J Pharma Sci, (20060000), vol. 96, no. 5, doi:10.1002/jps.20938, pages 1342 - 1355, XP055060697
OPPOSITION- XIAORONG HE et al., Journal of Pharmaceutical Sciences, (20060000), vol. 96, no. 5, pages 1342 - 1355, XP055060697
OPPOSITION- XIAORONG HE et al, "Mechanistic study of the effect of roller compaction and lubricant on tablet mechanical strength", JOURNAL OF PHARMACEUTICAL SCIENCES, (20070501), vol. 96, no. 5, pages 1342 - 1355, XP055060697
OPPOSITION- WITKAMP, R. F., "Current and Future Drug Targets in Weight Management", Pharm Res, (20110000), vol. 28, doi:10.1007/s11095-010-0341-1, pages 1792 - 1818, XP019921746
OPPOSITION- GRANHALL et al., "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, (20180000), vol. 58, no. 6, doi:10.1007/s40262-018-0728-4, ISSN 0312-5963, pages 781 - 791, XP055545538
OPPOSITION- MARRE, M. et al., "GLP-1 receptor agonists today", Diabetes Research and Clinical Practice, (20110000), vol. 93, doi:10.1016/j.diabres.2011.01.004, pages 317 - 327, XP028289489
OPPOSITION- TENG Y et al., "Systematical approach of formulation and process development using roller compaction", European Journal of Pharmaceutics and Biopharmaceutics, (20090000), vol. 73, pages 219 - 239, XP026652682
OPPOSITION- BEGLINGER et al., "Pharmacokinetics and Pharmacodynamic Effects of Oral GLP-1 and PYY3-36: A Proof of Concept Study in Healthy Subjects", Clinical Pharmacology and Therapeutics, (20080000), vol. 84, no. 4, doi:10.1038/clpt.2008.35, pages 468 - 474, XP008149454
OPPOSITION- STEINERT et al., "Orally administered glucagon-like peptide receptor 1 affects glucose homeostasis following an oral glucose tolerance test in healthy male subjects", Clinical Phamacology and Therapeutics, (20090000), vol. 86, no. 6, doi:10.1038/clpt.2009.159, pages 644 - 650, XP002635568
OPPOSITION- STEINERT RE et al., CLINICAL PHARMACOLOGY AND THERAPEUTICS, (20090000), vol. 86, no. 6, pages 644 - 650, XP002635568
OPPOSITION- STEINERT R. E. et al, "Orally Administered Glucagon-Like Peptide-1 Affects Glucose Homeostasis Following an Oral Glucose Tolerance Test in Healthy Male Subjects", CLINICAL PHARMACOLOGY & THERAPEUTICS, (20091201), vol. 86, no. 6, pages 644 - 650, XP002635568
OPPOSITION- GOLDBERG et al., "Challenges for the oral delivery of macromolecules", Nature Reviews, (20030000), vol. 2, doi:10.1038/nrd1067, pages 289 - 295, XP055085694
OPPOSITION- Helena J. Venables & J. I. Wells, "Powder Mixing", Drug Development and Industrial Pharmacy, (20010702), vol. 27, no. 7, pages 599 - 612, XP055635103
OPPOSITION- VON EGGELKRAUT-GOTTANKA et al., "Roller compaction and tabletting of St. John's wort plant dry extract using a gap width and force controlled roller compactor. II. Study of roller compaction variables on granule and tablet properties by a 3(3) factorial design", Pharmaceutical Development and Technology, (20020000), vol. 7, no. 4, pages 447 - 455, XP008166170
OPPOSITION- KIKUTA et al., "Effect of mixing time on the lubricating properties of magnesium stearate and the final characteristics of the compressed tablets", Drug development and industrial pharmacy, (19940000), vol. 20, no. 3, pages 343 - 355, XP055635107
OPPOSITION- "Intestinal Permeation Enhancers for Oral Delivery of Macromolecules: A Comparison between Salcaprozate Sodium (SNAC) and Sodium Caprate (C10)", Pharmaceutics, (20190213), vol. 11, no. 2, page 78, XP055634457
OPPOSITION- STEINERT et al., "Oral administration of glucagon- like peptide 1 or peptide YY 3-36 affects food intake in healthy male subjects", Am J Clin Nutr, (20101000), vol. 92, no. 4, pages 810 - 817, XP002677085

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