Rapid Dissolution Formulation Of A Calcium Receptor-Active Compound - EP3578175

The patent EP3578175 was granted to Amgen on Nov 30, 2022. The application was originally filed on Sep 10, 2004 under application number EP19164145A. The patent is currently recorded with a legal status of "Revoked".

EP3578175

AMGEN
Application Number
EP19164145A
Filing Date
Sep 10, 2004
Status
Revoked
Feb 21, 2025
Grant Date
Nov 30, 2022
External Links
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Patent Summary

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Patent Family

Patent Oppositions (7)

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BIOGARANAug 30, 2023CASALONGAADMISSIBLE
GLENMARK PHARMACEUTICALS EUROPEAug 30, 2023SCHLICHADMISSIBLE
TAD PHARMAAug 30, 2023HOEFER & PARTNER PATENTANWALTE MBBWITHDRAWN
ARROW GENERIQUES PUREN PHARMAAug 29, 2023HAMM & WITTKOPPADMISSIBLE
ELKINGTON AND FIFEAug 29, 2023ELKINGTON AND FIFEADMISSIBLE
SANDOZAug 29, 2023MAIWALDADMISSIBLE
HAMM & WITTKOPPAug 24, 2023HAMM & WITTKOPPADMISSIBLE

Patent Citations (43) New

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

Citation PhasePublication NumberPublication Link
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Non-Patent Literature (NPL) Citations (83) 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
DESCRIPTION- BERGE et al., J. Pharm. Sci., (19770000), vol. 66, page 1-
EXAMINATION- FRANCESCHINI N ET AL, "CINACALCET HCI: A CALCIMIMETIC AGENT FOR THE MANAGEMENT OF PRIMARY AND SECONDARY HYPERPARATHYROIDISM", EXPERT OPINION ON INVESTIGATIONAL DRUGS, INFORMA HEALTHCARE, UK, (20030101), vol. 12, no. 8, doi:10.1517/13543784.12.8.1413, ISSN 1354-3784, pages 1413 - 1421, XP009083254
OPPOSITION- Ainley Wade and Paul J Weller, "Microcrystalline Cellulose / Crospovidone / Pregelatinized Starch", Ainley Wade and Paul J Weller, Ainley Wade and Paul J Weller, Handbook of Pharmaceutical Excipients, (19940101), pages 84 - 87,143-144,491-493, ISBN 978-0-85369-305-5, XP055673621-
OPPOSITION- A. L. Negri null, "Agentes Calciomiméticos en el Tratamiento del Hiperparatiroidismo Primario y Secundario", REEMO 2003; 12(4); 83-86 , (20037), vol. 12, XP055790209-
OPPOSITION- Anonymous, "(1088) IN VITRO AND IN VIVO EVALUATION OF DOSAGE FORMS", USP 26: The United States Pharmacopeia , USPC, (20030101), pages 2334 - 2335, XP093116943-
OPPOSITION- Anonymous, "2005 Pharma Achievement Award Finalists Announced", Bio-IT World News, Bio-IT World, (20050101), pages 1 - 3, Bio-IT World News, URL: http://www.bio-itworld.com/newsitems/2005/05/05-11-05-news-pharmawards/, XP093177141-
OPPOSITION- Anonymous, "(711) DISSOLUTION", USP 26: The United States Pharmacopeia, USPC, (20030101), pages 1 - 7, XP093116944-
OPPOSITION- Anonymous, "Amgen Submitted New Drug Applicatioin for Cinacalcet HCI", Amgen Press Release, (20030908), URL: https://www.amgen.com/newsroom/press-releases/2003/09/amgen-submitted-new-drug-applicatioin-for-cinacalcet-hci, XP093115786-
OPPOSITION- Anonymous, "Amgen Submitted New Drug Applicatioin for Cinacalcet HCI", Amgen Press Releases, (20030908), Amgen Press Releases, URL: https://www.amgen.com/newsroom/press-releases/2003/09/amgen-submitted-new-drug-applicatioin-for-cinacalcet-hci, (20240208), XP093129251-
OPPOSITION- Anonymous, "Amgen Submitted New Drug Applicatioin for Cinacalcet HCI ", Amgen's press release, (20030908), Amgen's press release, (20240112), XP093118729-
OPPOSITION- Anonymous, "A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis | ClinicalTrials.gov", (20130508), URL: https://clinicaltrials.gov/study/NCT00042653, (20240103), XP093115784-
OPPOSITION- Anonymous, "A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis | ClinicalTrials.gov", (20130508), URL: https://clinicaltrials.gov/study/NCT00042653, XP093115784-
OPPOSITION- Anonymous, "A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis", ClinicalTrials.gov Identifier: NCT00042653, (20130508), ClinicalTrials.gov Identifier: NCT00042653, URL: https://classic.clinicaltrials.gov/ct2/show/NCT00042653?term=NCT00042653&draw=2&rank=1, (20240112), XP093118728-
OPPOSITION- Anonymous, "A Study of an Investigational Medication for the Treatment of Secondary Hyperparathyroidism in Patients on Dialysis", ClinicalTrials.gov /NCT00042653/, (20020806), ClinicalTrials.gov /NCT00042653/, URL: https://clinicaltrials.gov/ct2/show/NCT00042653, (20200226), XP055671896-
OPPOSITION- Anonymous, "Biopharmaceutical principles of drug delivery", Anonymous, Michael E Aulton, Pharmaceutics The Science of Dosage Form Design, London UK, Harcourt Publishers Limited, (20020101), pages 244 - 249, XP093129484-
OPPOSITION- Anonymous, "Chapter 905 Uniformity of Dosage Units", The United States Pharmacopeia, US, The United States Pharmacopeia Convention, Inc., (20030101), vol. USP 26, pages 2227 - 2229, ISBN 1-889788-13-9, XP009555087-
OPPOSITION- Anonymous, "Cinacalcet ", DrugBank, (20050613), DrugBank, URL: https://go.drugbank.com/drugs/DB01012, (20240106), XP093116417-
OPPOSITION- Anonymous, "Dosage from design and manufacture", Anonymous, Michael E Aulton, Pharmaceutics The Science of Dosage Form Design, London UK, Harcourt Publishers Limited, (20010101), pages 404 - 412, XP093129488-
OPPOSITION- Anonymous, "Drug Approval Package: Sensipar (Cinacalcet HCI) NDA #021688", (20040507), URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm, XP093115782-
OPPOSITION- Anonymous, "Feste und trockene Arzneiformen", Anonymous, Ursula Schoffling, Arznei-Formenlehre, Deutscher Apotheker Verlag, (19980101), pages 188 - 189, XP093129464-
OPPOSITION- Anonymous, "International Nonproprieta Names for Pharmaceutical Substances (INN) ", World Health Organization, (20030101), vol. 17, no. 1, pages 41 - 77, XP093129492-
OPPOSITION- Anonymous, "Sensiparâ„¢ (cinacalcet HCI) Tablets", AMGEN - Product Label, (20040101), AMGEN - Product Label, (20240112), XP093118708-
OPPOSITION- Anonymous, "Winners of the 2005 Pharma Achievement Awards", Bio-IT World News, Bio-IT World, (20050101), pages 1 - 4, Bio-IT World News, URL: http://www.bio-itworld.com/newsitems/2005/05/05-11-05-news-pharmawards/, XP093177154-
OPPOSITION- Anonymus, "NDA 21-688 Sensipar 30, 60, 90 mg Tablets", Chemistry reviews, Application number 21-688. Center for drug evaluation and research, (20040201), XP055677936-
OPPOSITION- Augsburger Larry L., Brzeczko, Shah, Hahm, Swarbrick, Boylan, "Super Disintegrants: Characterization and Function", Encyclopedia of pharmaceutical technology, New York, Dekker, (19880101), pages 268 - 293, ISBN 978-0-8247-2800-7, XP093118742-
OPPOSITION- Banakar Umesh V., "Table 5.2 Factors Influencing Dissolution Rate of Drugs from Tablets and Capsules", Pharmaceutical Dissolution Testing, Marcel Dekker Inc. , (19920101), pages 136 - 137, XP093118296-
OPPOSITION- Bradway Robert A., "A Letter From Amgen's Chairman and Chief Executive Officer", Amgen Stories, Amgen Inc., (20130404), pages 1 - 4, Amgen Stories, URL: https://www.amgen.com/stories/2013/04/a-letter-from-amgens-chairman-and-chief-executive-officer, XP093177169-
OPPOSITION- Bronson Barbara, "First-In-Class Oral Calcimimetic Shown To Reduce Parathyroid Hormone Levels In Chronic Kidney Disease ", Amgen's press release, (20021103), pages 1 - 2, Amgen's press release, (20240112), XP093118702-
OPPOSITION- B. Wang et al., "PHARMACOKINETICS (PK) OF CALCIMIMETIC AMG 073 IN SECONDARY HYPERPARATHYROIDISM (SHPT)", Clinical Pharmacology & Therapeutics, (2001), vol. 69, XP093115779-
OPPOSITION- Excerpt from National Drug Code Directory; 12th column, XP093118704-
OPPOSITION- Fda, "CINACALCET HYDROCHLORIDE (SENSIPAR) TABLET EQ 30MG BASE", Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, (20200101), pages 1 - 2, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, URL: https://www.fda.gov/, (20240106), XP093116418-
OPPOSITION- Fda, "Drug approval Package: Sensipar (Cinacalcet HCI) NDA #021688", (20040101), URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-688_Sensipar.cfm, (20200304), XP055673613-
OPPOSITION- Fda, "Sensipar (Cinacalcet HCI) Tablets", Drug Approval Package, (20040507), pages 1 - 2, Drug Approval Package, URL: https://www.accessdata.fda.gov/, (20240106), XP093116415-
OPPOSITION- Fda, "SENSIPAR (cinacalcet hydrochloride) 30,60,90 mg Tablets", CENTER FOR DRUG EVALUATION AND RESEARCH. Chemistry Review(s), Application no. 21-688, (20040303), CENTER FOR DRUG EVALUATION AND RESEARCH. Chemistry Review(s), Application no. 21-688, (20240106), XP093116416-
OPPOSITION- Fda, "SENSIPAR (cinacalcet hydrochloride) 30, 60, 90 mg Tablets", CENTER FOR DRUG EVALUATION AND RESEARCH - Chemistry Review(s); application number 21-688, (20040301), CENTER FOR DRUG EVALUATION AND RESEARCH - Chemistry Review(s); application number 21-688, (20240112), XP093118714-
OPPOSITION- Fda, "Sensipar (Cinacalcet MCI) Tablet", Drug Approval Package, (20040803), pages 1 - 2, Drug Approval Package, (20240112), XP093118710-
OPPOSITION- Fda, "SENSIPARâ„¢", CENTER FOR DRUG EVALUATION AND RESEARCH. APPLICATIONNUMBER: 21-688 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S), (20030905), CENTER FOR DRUG EVALUATION AND RESEARCH. APPLICATIONNUMBER: 21-688 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S), (20240112), XP093118724-
OPPOSITION- Fda, "Sensiparâ„¢ (cinacalcet HCI) Tablets", CENTER FOR DRUG EVALUATION AND RESEARCH D25 APPLICATIONNUMBER: 21-688. APPROVED LABELING, (20040803), CENTER FOR DRUG EVALUATION AND RESEARCH D25 APPLICATIONNUMBER: 21-688. APPROVED LABELING, (20240109), XP093116937-
OPPOSITION- Fiese E. F., Hagen, Lachman, Lieberman, Kanig, "Preformulation", The Theory and Practice of Industrial Pharmacy. 3re ed., Varghese Publishing House, (19870101), pages 171 - 197, 298-303, XP093118740-
OPPOSITION- "First-In-Class Oral Calcimimetic Shown To Reduce Parathyroid Hormone Levels In Chronic Kidney Disease", Amgen Press Release, (20021103), Amgen Press Release, URL: https://www.amgen.com/newsroom/press-releases/2002/11/first-in-class-oral-calcimimetic-shown-to-reduce-parathyroid-hormone-levels-in-chronic-kidney-disease, XP093115780-
OPPOSITION- Frazao Joao M, Patricia Martins , Jack W Coburn , "The calcimimetic agents: Perspectives for treatment", Kidney International, (20020101), vol. 61, no. Supplement 80 , pages S149 - S154, XP093129470-
OPPOSITION- Gibaldi, "Biopharmaceutics and Clinical Pharmacokinetics", (19910101), page 51, (20161007), XP055308521-
OPPOSITION- GOODMAN W G , ET AL, "The Calcimimetic agent AMG 073 lowers plasma parathyroid hormone levels in hemodialysis patients with secondary hyperparathyroidism.", Journal of the American Society of Nephrology, WILLIAMS AND WILKINS, BALTIMORE, MD., US, US , (20020401), vol. 13, no. 4, ISSN 1046-6673, pages 1017 - 1024, XP002313387-
OPPOSITION- Herbert P. Fiedler, "Tab", Lexikon der Hilfsstoffe für Pharmazie, Kosmetik und angrenzende Gebiete, Aulendorf, Editio Cantor, (20020101), pages 1642 - 1646, ISBN 3-87193-230-2, XP009555085-
OPPOSITION- Kathleen Lee, "Overview of Drug Product Development", Current Protocols in Pharmacology, (20010101), pages 1 - 10, XP093129476-
OPPOSITION- Kibbe Arthur H., "Cellulose Microcrystalline , Povidone, Magnesium Stearate, Crospovidone, Starch Pregelatinized, Lactose, Calcium Phosphate, Dibasic AnhydrousMannitol, Sorbitol, Hydroxypropyl Methylcellulose, Carboxymethylcellulose Sodium, Hydroxypropyl Cellulose", Handbook of pharmaceutical excipients. 3rd ed., American Pharmaceutical Association, (20000101), XP093118700-
OPPOSITION- Kibbe Arthur H., Handbook of Pharmaceutical Excipients, 3rd ed., (20000101), pages 87, 102, 103, 143, 163, 164, 244, 305 - 306, 324 433, 515, 528, 529, XP093115776-
OPPOSITION- K. L. Andrew Chan et al., "Applications of Attenuated Total Reflection Infrared Spectroscopic Imaging to Pharmaceutical Formulations", Anal. Chem. 2003, 75, 2140-2146 , (20035), vol. 75-
OPPOSITION- Lachman Leon, Herbert A. Lieberman, Joseph L. Kanig, "Weight Variation", The theory and practice of Industrial Pharmacy. 3rd ed., VARGHESE PUBLISHING HOUSE, (19870101), pages 300 - 303, XP093116938-
OPPOSITION- Lee Kathleen M., "7.3 Overview of Drug Product Developme", Pharmacokinetics. Current Protocols in Pharmacology, (20010101), pages 7.3.1 - 7.3.10, XP093118766-
OPPOSITION- Lieberman Herbert A., Leon Lachman, Joseph B. Schwartz, "Cellulose", Lieberman Herbert A., Leon Lachman, Joseph B. Schwartz, LIEBERMAN H.A.; LACHMAN L.; SCHAWARTZ J.B., Pharmaceutical Dosage Forms: Tablets, US , Marcel Dekker , (19890101), pages 210 - 211, ISBN 978-0-8247-8044-9, XP093116949-
OPPOSITION- Limdberg Jill S, Et Al., "Cinacalcet HCI, an oral Calcimimetic agent for the treatment of secondary hyperparathyroidism in hemoddialysis and peritoneal dialysis: A randomized, double-blind , multicenter study", American Society of Nephrology, (20050101), vol. 16, XP055966686-
OPPOSITION- Lindberg Jill S. et al., "Cinacalcet HCI, an oral Calcimimetic agent for the treatment of secondary hyperparathyroidism in hemoddialysis and peritoneal dialysis: A randomized, double-blind , multicenter study", American Society of Nephrology, (20050101), vol. 16, XP055966686-
OPPOSITION- Raymond C. Rowe, "Arrangement", Raymond C. Rowe, Royal Pharmaceutical Society of Great Britain, Handbook of Pharmaceutical Excipients, UK/USA , Pharmaceutical Press; The American Pharmacists Association , (20060101), pages xvii - xviii, ISBN 0-85369-618-7, XP009555086-
OPPOSITION- Remington, "Remington, The Science and Practice of Pharmacy", Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins , (20000101), pages 656,chapter 45, 858 - 870,885,1970, ISBN 978-0-683-30647-7, XP055301025-
OPPOSITION- Ritschel W A, A Bauer -Brandl, "Standard Tabletten", Die Tablette Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Edito Cantor Verlag , (20020101), pages 20, - 116, 123, 126-129, 478-480, ISBN 978-3-87193-228-1, XP093118691-
OPPOSITION- Ritschel W A, A Bauer -Brandl, "Standard Tabletten", Die Tablette Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Edito Cantor Verlag , (20020101), pages 20 - 21, 73, 115-116, 123, 126-130, 478-480, ISBN 978-3-87193-228-1, XP093118691-
OPPOSITION- Ritschel W.A., Bauer-Brandl, Die Tablettte - handbuch der entwicklung, herstellung und qualitatssicherung, 2.Auflage, (20020101), pages 20, 21, 63 - 73, 115, 116, 123, 126 - 129, 478 - 480, XP093115737-
OPPOSITION- Ritschel Wolfgang A., Annette Bauer-Brandl, "Mikrokristalline Cellulose", Die Tablette Handbuch der Entwicklung, Herstellung und Qualitätssicherung, Edito Cantor Verlag , (20020101), page 86, 259, ISBN 978-3-87193-228-1, XP093116951-
OPPOSITION- Rowe, Sheskey Paul J, Quinn Marian E, "Cellulose. Microcrystalline, Colloidal Silicon Dioxide, Crospovidone, Magnesium Stearate, Povidone, Starch, Pregelatinized", Handbook of Pharmaceutical Excipients. 6th ed., Pharmaceutical Press and American Pharmacists Association, (20090101), pages 129 - 582, 691-692, XP093118734-
OPPOSITION- Rudnic Edward M., Schwartz Joseph D, Gennaro Alfonso R., "Salt Expansion: Exploring the Molecular Possibilities of A'. Oral Solid Dosage Forms", Remington: The Science and Practice of Pharmacy, Lippincott Williams & Wilkins , (20000101), pages 704. 858 - 893, ISBN 978-0-683-30647-7, XP093118752-
OPPOSITION- Rudolf Voigt, "8.5 Hilfsstoffe zur Tablettierung", Lehrbuch der pharmazeutischen Technologie, Weinheim, Verlag Chemie, (19790101), pages 193 - 200, ISBN 3-527-25667-9, XP009555084-
OPPOSITION- "SENSIPAR (CINACALCET HCL) TABLETS", (20040308), URL: http://www.fda.gov/cder/foi/label/2004/21688_Sensipar_lbl.pdf, XP002400332-
OPPOSITION- Sensipar, "cinacalcet", Search Orphan Drug Designations and Approvals, FDA US Food & Drug Administration, (20030512), pages 1 - 1, Search Orphan Drug Designations and Approvals , URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=163402, XP093176962-
OPPOSITION- Sensipar, "cinacalcet", Search Orphan Drug Designations and Approvals, FDA US Food & Drug Administration, (20100430), pages 1 - 2, Search Orphan Drug Designations and Approvals , URL: https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=165102, XP093176964-
OPPOSITION- U. V. Banakar, "Pharmaceutical Dissolution Testing", (19920101), pages 136 - 137, (20160818), XP055296133-
OPPOSITION- U. V. Banakar, Pharmaceutical Dissolution Testing, Marcel Dekker , (19920101), pages 136 - 137, XP055641322-
OPPOSITION- Wade Ainley, Paul J Weller, "Microcrystalline Cellulose", Handbook of Pharmaceutical Excipients, 2nd ed, The Pharmaceutical Press, (19940101), pages 84 - 87, XP093116945-
OPPOSITION- Wang B., K. Osborn Et Al., "PIII-107 - PHARMACOKINETICS (PK) OF CALCIMIMETIC AMG 073 IN SECONDARY HYPERPARATHYROIDISM (SHPT)", CLINICAL PHARMACOLOGY & THERAPEUTICS, Abstracts of Papers, (20010101), vol. 69, no. 2, page P91, XP093115779-
OPPOSITION- Wells James, Aiderborn Goran, Aulton Michael E., "8 Pharmaceutical preformulation: the physicochemical properties of drug substances. 27 Tablets and compaction", Pharmaceutics The Science of Dosage Form Design. 2nd ed., Churchill Livingston, (20020101), pages 113 - 440, XP093118747-
OPPOSITION- Zheng Jack Y., "An Overview", Zheng Jack Y., Zheng Jack, Formulation and analytical development for low-dose oral drug products, Hoboken, N.J. , John Wiley & Sons, Inc. , (20090122), pages 1 - 21, doi:10.1002/9780470386361.ch1, ISBN 978-0-470-05609-7, XP093176947
OPPOSITION- Eugene S. Barabas, "Chapter 3: Crospovidone", Eugene S. Barabas, Harry G. Brittain, Analytical Profiles of Drug Substances and Excipients, Elsevier, (19960101), vol. 24, pages 87 - 163, doi:10.1016/S0099-5428(08)60692-9, ISSN 1075-6280, ISBN 978-0-12-260824-7, XP093167295
OPPOSITION- Darryl L. Quarles et al., "The Calcimimetic AMG 073 as a Potential Treatment for Secondary Hyperparathyroidism of End-Stage Renal Disease", Journal of the American Society of Nephrology, (2003), vol. 14, doi:10.1097/01.ASN.0000050224.03126.AD, XP055671891
OPPOSITION- L. D. Quarles, Donald J Sherrard, Stephen Adler, Steven J Rosansky, Laura C Mccary, Wei Liu, Stewart A Turner, David A Bushinsky, "The Calcimimetic AMG 073 as a Potential Treatment for Secondary Hyperparathyroidism of End-Stage Renal Disease", Journal of the American Society of Nephrology, WILLIAMS AND WILKINS, BALTIMORE, MD., US, US , (20030301), vol. 14, no. 3, doi:10.1097/01.ASN.0000050224.03126.AD, ISSN 1046-6673, pages 575 - 583, XP055671891
OPPOSITION- Zaborenko Nikolay; Shi Zhenqi; Corredor Claudia C.; Smith-Goettler Brandye M.; Zhang Limin; Hermans Andre; Neu Colleen M.; Alam Md Anik; Cohen Michael J.; Lu Xujin; Xiong Leah; Zacour Brian M., "First-Principles and Empirical Approaches to PredictingIn VitroDissolution for Pharmaceutical Formulation and Process Development and for Product Release Testing", The AAPS Journal, Springer International Publishing, Cham, Cham , (20190221), vol. 21, no. 3, doi:10.1208/s12248-019-0297-y, pages 1 - 20, XP036830033
OPPOSITION- FRANCESCHINI N. et al, "CINACALCET HCI: A CALCIMIMETIC AGENT FOR THE MANAGEMENT OF PRIMARY AND SECONDARY HYPERPARATHYROIDISM", Expert Opinion on Investigational Drugs, Informa Healthcare, UK, UK , (20030101), vol. 12, no. 8, doi:10.1517/13543784.12.8.1413, ISSN 1354-3784, pages 1413 - 1421, XP009083254
OPPOSITION- Nora Franceschini et al., "Cinacalcet HCl: a calcimimetic agent for the management of primary and secondary hyperparathyroidism", Expert Opin. Investig. Drugs, (2003), vol. 12, doi:10.1517/13543784.12.8.1413, XP009083254
OTHER- Amgen, Inc.,, "NDA 21-688 - SENSIPAR (cinacalcet hydrochloride) 30,60,90 mg Tablets", CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 21-688 CHEMISTRY REVIEW(S), page 22pp-
OTHER- Anonymous, "Sensiparâ„¢ (cinacalcet HCI) Tablets", Amgen Inc.,, (20040803), pages 1 - 17, XP055789588-
SEARCH- AMGEN, "Amgen submitted new drug application for Cinacalcet HCI", (20030908), AMGEN NEWS RELEASE, URL: http://www.amgen.com/news/news03/pressRelease030908a.pdf, (20050112), XP002313388 [A] 1-15 * the whole document *-
SEARCH- GOODMAN WILLIAM G ET AL, "The Calcimimetic agent AMG 073 lowers plasma parathyroid hormone levels in hemodialysis patients with secondary hyperparathyroidism.", JOURNAL OF THE AMERICAN SOCIETY OF NEPHROLOGY : JASN. APR 2002, (200204), vol. 13, no. 4, ISSN 1046-6673, pages 1017 - 1024, XP002313387 [Y] 1-15 * table 2 *-
SEARCH[ ] - NEMETH EDWARD F ET AL, "Pharmacodynamics of the type II calcimimetic compound cinacalcet HCl.", THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS. FEB 2004, (200402), vol. 308, no. 2, ISSN 0022-3565, pages 627 - 635, XP009042339 [ ] * the whole document *
SEARCH- DRUGS IN R&D, "Cinacalcet: AMG 073, Calcimimetics--Amgen/NPS Pharmaceuticals, KRN 1493, NPS 1493.", DRUGS IN R&D. 2003, (20030101), vol. 4, no. 6, ISSN 1174-5886, pages 349 - 351, XP009042342 [A] 1-15 * the whole document *

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