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Stable Liquid Formulation Of Amg 416 Hcl (Etelcalcetide) - EP3246017

The patent EP3246017 was granted to Amgen on Mar 24, 2021. The application was originally filed on Jun 27, 2014 under application number EP17160312A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3246017

AMGEN
Application Number
EP17160312A
Filing Date
Jun 27, 2014
Status
Granted And Under Opposition
Feb 19, 2021
Grant Date
Mar 24, 2021
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (4)

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ADALVODec 22, 2021SLAVIKADMISSIBLE
STADA ARZNEIMITTELDec 22, 2021HAMM & WITTKOPPADMISSIBLE
SYNTHONDec 22, 2021HAMM & WITTKOPPADMISSIBLE
FRESENIUS KABI DEUTSCHLANDDec 21, 2021FRESENIUS KABI DEUTSCHLANDADMISSIBLE

Patent Citations (7) New

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

Citation PhasePublication Number
DESCRIPTIONWO2011014707
OPPOSITIONEP2399604
OPPOSITIONWO2007040711
OPPOSITIONWO2012170955
OPPOSITIONWO2013071262
SEARCHWO2011014707
SEARCHWO2015154031

Non-Patent Literature (NPL) Citations (41) 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
OPPOSITION- AKERS et al., "Peptides and Proteins as Parenteral Solutions", Pharmaceutical Formulation Development of Peptides and Proteins, (20000000), XP055454710
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OPPOSITION- Anonymous, "Assessment Report for Parsabiv", European Medicines Agency Sciences Medicines Health, (20160915), pages 1 - 10, XP055909221
OPPOSITION- Anonymous, "History of changes for study: NCT01576146 Open-label Study to Assess the Long-term Safety and Efficacy of AMG 416 (Also Known as KAI-4169) in Patients With Secondary Hyperparathyroiddism", ClinicalTrials.gov, (20170501), pages 1 - 6, XP055909238
OPPOSITION- ANONYMOUS, "History of changes for study: NCT01576146 Open-label Study to Assess the Long-term Safety and Efficacy of AMG 416 (Also Known as KAI-4169) in Patients With Secondary Hyperparathyroiddism", ClinicalTrials.gov, (20170501), pages 1 - 6, XP055909238
OPPOSITION- Anonymous, "History of changes for study: NCT01785849 20120229: Assess the Efficacy and Safety of AMG 416 in the treatment of Secondary Hyperparathyroidism (SHPT) in Subjects with Chronic Kidney Disease on Hemodialysis", ClinicalTrials.gov, (20190805), pages 1 - 15, XP055909230
OPPOSITION- Anonymous, "Note for Guidance on Stability Testing: Stability Testing of New Drug Substances and Products", European Medicines Agency, (20030800), pages 1 - 20, XP055908989
OPPOSITION- "A survey in the 1995 issue of Index Nominum yielded the following results", P. Heinrich Stahl, Handbook of Pharmaceutical Salts, (20110000), XP055447611
OPPOSITION- AULTON, MICHAEL E. et al., "Design of Dosage Forms; Dosage Form Design and Manufacture; Delivery of Pharmeceutical Proteins", Aulton's Pharmaceutics: The Design and Manufacture of Medicines Third Edition, Edinburgh, (20070000), pages 8, 368-369 - 616-620, XP055908976
OPPOSITION- Bauer K. H. et al., "Kapitel 9 : Parenteralia, einschlieBlich Blutzubereitungen, Sera und Impfstoffe", Pharmazeutische Technologie, (19930000), pages 225 - 228, XP055877953
OPPOSITION- Burcu Devrim, "Parental Preparations", PHA486 PHARMACEUTICAL TECHNOLOGY IV, pages 1 - 73, URL: https://acikders.ankara.edu.tr/course/view.php?id=5752
OPPOSITION- CARL, S.M. et al., "Biotechnology-Derived Drug Product Development", Pharmaceutical Manufacturing Handbook, (20080000), pages 19-21 - 330-333, XP055909004
OPPOSITION- C. AVANTI, "Innovative strategies for stabilization of therapeutic peptides in aqueous formulations", Thesis, (20120000), pages 1 - 34, XP055127921
OPPOSITION- "chapter 9 Parenteralia, einschlieBlich Blutzubereitungen, Sera und Impfstoffe", Bernhard C et al, LEHRBUCH DER PHARMAZEUTISCHEN TECHNOLOGIE, Stuttgart, (20060000), XP055877953
OPPOSITION- D Voet, G Voet, "Säuren, Basen und Puffersysteme", Biochemie, VCH Verlag , (19940101), pages 35 - 41, ISBN 978-3-527-29249-3, XP055455581
OPPOSITION- "Formulation and Packaging", Pharmaceutical Dosage Forms - Parental Medications Third Edition Volume 1, 20100000, vol. 1, pages 222 - 253, XP055874783
OPPOSITION- Fukagawa Masafumi, Et Al., "Hyperparathyroidism in chronic kidney disease patients: an update on current pharmacotherapy", Expert Opin. Pharmacother, (20130000), vol. 14, no. 7, pages 863 - 871, XP055909639
OPPOSITION- FUKAGAWA MASAFUMI ET AL, "Hyperparathyroidism in chronic kidney disease patients: an update on current pharmacotherapy", Expert Opin. Pharmacother, (20130000), vol. 14, no. 7, pages 863 - 871, XP055909639
OPPOSITION- H Feltkamp, P Fuchs, H Sucker, "4. Haltbarkeit von Wirkstoffen und Arzneizubereitungen", Pharmazeutische Qualitätskontrolle, Georg Thieme Verlag Stuttgart New York , (19830101), pages 502 - 511, XP055420091
OPPOSITION- JACOB et al., "Stability of proteins in aqueous solution and solid state", Indian J Pharm Sci, (20060000), vol. 68, no. 2, pages 154 - 163, XP009088344
OPPOSITION- JEFFREY L. et al., "Formulation and Delivery of Proteins and Peptides - Design and Development Strategies", Pharmaceutical Research and Development, (19940819), pages 1 - 19, XP055908912
OPPOSITION- JR, ALLEN et al., "Section II Drug Dosage Form and Drug Delivery System Design", Ansel's pharmaceutical dosage forms and drug delivery systems, (20120000), pages 90 - 141, XP055908965
OPPOSITION- LACHMAN et al., "The Theory and practice of industrial pharmacy", The Theory and practice of industrial pharmacy, (19860000), XP055877941
OPPOSITION- LACHMAN, LEON et al., "The Theory and Practice of Industrial Pharmacy", The Theory and Practice of Industrial Pharmacy, (19860000), pages 190-195 - 764-768, XP055877941
OPPOSITION- Lars Hovgaard, Et Al, "8.2.1. Buffers", Pharmaceutical Formulation Development of Peptides and Proteins, (20130101), page 155, XP055579993
OPPOSITION- LONOVA Y et al., "Biologic excipients: Importance of clinical awareness of inactive ingredients", PLOS ONE, (20200000), vol. 15, no. 6, pages 1 - 13, XP055908908
OPPOSITION- Mark B. Abelson, et al., "Controlling for the Placebo Effect", Review of Ophthalmology, (20030417), URL: https://www.reviewofophthalmology.com/article/controlling-for-the-placebo- effect, XP055877936
OPPOSITION- Michael E. Aulton, "DESIGN OF DOSAGE FORMS", Aulton's Pharmaceutics, Elsevier, (20070000), 3rd edition, XP055877950
OPPOSITION- Michael F. Powell, "Chapter 7 Peptide Stability in Aqueous Parenteral Formulations Prediction of Chemical Stability Based on Primary Sequence", FORMULATION AND DELIVERY OF PROTEINS AND PEPTIDES,, (19940000), vol. 567, pages 100 - 117, XP055877948
OPPOSITION- Nema Sandeep et al., "Formulation and Packaging", Pharmaceutical Dosage Forms, (20100000), vol. 1, pages 222 - 253, XP055874783
OPPOSITION- Paula D. Johnson et al., "Practical Aspects of Experimental Design in Animal Research", ILAR Journal, (20020000), vol. 43, no. 4, XP055877935
OPPOSITION- WALTER S; BARUCH A; DONG J; TOMLINSON J E; ALEXANDER S T; JANES J; HUNTER T; YIN Q; MACLEAN D; BELL G; MENDEL D B; JOHNSON R M; KA, "Pharmacology of AMG 416 (Velcalcetide), a Novel Peptide Agonist of the Calcium-Sensing Receptor, for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients", JPET Fast Forward, pages 1 - 53, XP055909659
OPPOSITION- Walter S; Baruch A; Dong J; Tomlinson J E; Alexander S T; Janes J; Hunter T; Yin Q; Maclean D; Bell G; Mendel D B; Johnson R M; Karim F, "Pharmacology of AMG 416 (Velcalcetide), a Novel Peptide Agonist of the Calcium-Sensing Receptor, for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients", JPET Fast Forward, (20130514), pages 1 - 53, XP055909659
OPPOSITION- WANG et al., "Parenteral Formulations of Proteins and Peptides: Stability and Stabilizers", Journal of Parenteral Science and Technolog y, (19880000), vol. 42, no. 2S, XP055877945
OPPOSITION- Wang J. Y., Et Al., "Parental Formulations of Proteins and Peptides: Stability and Stabilizers ( Technical Report No. 10)", Journal of Parenteral Science and Technology, (19880000), vol. 42, pages S3 - S26, XP055909680
OPPOSITION- WANG J. Y., ET AL, "Parental Formulations of Proteins and Peptides: Stability and Stabilizers ( Technical Report No. 10)", Journal of Parenteral Science and Technology, (19880000), vol. 42, pages S3 - S26, XP055909680
OPPOSITION- WANG Y-C J; HANSON M A, "Parenteral formulations of proteins and peptides: stability and stabilizers", Journal of Parenteral Science and Technology, (19880000), vol. 42, pages S1 - S24, XP002911772
OPPOSITION- VOLKIN et al., "Degradative Covalent Reactions Important to Protein Stability", Molecular Biotechnology, (19970000), vol. 8, doi:10.1007/BF02752255, XP037124905
OPPOSITION- SARAH WALTER et al., "Pharmacology of AMG 416 (velcalcetide), a Novel Peptide Agonist of the Calcium Sensing Receptor, for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients", Journal of Pharmacology and Experimental Therapeutics, (20130514), pages 1 - 13, XP055275398
OPPOSITION- WALTER et al., "Pharmacology of AMG 416 (Velcalcetide), a Novel Peptide Agonist of the Calcium-Sensing Receptor, for the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients", J Pharmacol Exp Ther, (20130514), vol. 346, doi:10.1124/jpet.113.204834, pages 229 - 240, XP055275398
SEARCH- SHEN JUN ET AL, "A pharmacokinetic/pharmacodynamic model for AMG 416, a novel calcimimetic peptide, following a single intravenous dose in healthy subjects.", vol. 54, no. 10, ISSN 1552-4604, (201410), pages 1125 - 1133, JOURNAL OF CLINICAL PHARMACOLOGY OCT 2014, URL: http://onlinelibrary.wiley.com/doi/10.1002/jcph.314/pdf, (20140923), XP002730170 [A] 1-15 * the whole document * * abstract *

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