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Dosing Regimen For Missed Doses For Long-Acting Injectable Paliperidone Esters - EP3744326

The patent EP3744326 was granted to Janssen Pharmaceutica on Dec 6, 2023. The application was originally filed on Mar 30, 2016 under application number EP20169861A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3744326

JANSSEN PHARMACEUTICA
Application Number
EP20169861A
Filing Date
Mar 30, 2016
Status
Granted And Under Opposition
Nov 3, 2023
Grant Date
Dec 6, 2023
External Links
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Patent Oppositions (9)

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ADVANZ PHARMA SERVICES UKSep 6, 2024FUCHS PATENTANWALTE PARTNERSCHAFT MBBADMISSIBLE
APPLEYARD LEESSep 5, 2024APPLEYARD LEESADMISSIBLE
HOFFMANN EITLESep 5, 2024HOFFMANN EITLEADMISSIBLE
STADA ARZNEIMITTELSep 5, 2024HAMM & WITTKOPPADMISSIBLE
ELKINGTON AND FIFESep 4, 2024ELKINGTON AND FIFEADMISSIBLE
SANDOZSep 4, 2024MAIWALDADMISSIBLE
STRAWMANSep 4, 2024VOSSIUS & PARTNER PATENTANWALTE RECHTSANWALTE MBBADMISSIBLE
ACCORD HEALTHCAREAug 28, 2024BRAND MURRAY FULLERADMISSIBLE
TEVA PHARMACEUTICALSAug 28, 2024D YOUNGADMISSIBLE

Patent Citations (12) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2009163519
DESCRIPTIONUS5254556
DESCRIPTIONUS6077843
DESCRIPTIONUS6555544
DESCRIPTIONWO2006114384
OPPOSITIONUS2009163519
OPPOSITIONUS2011105536
OPPOSITIONWO2011053829
OPPOSITIONWO2016164218
OTHERWO2016164218
SEARCHUS2009163519
SEARCHUS2011105536

Non-Patent Literature (NPL) Citations (53) 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- Fda, "HIGHLIGHTS OF PRESCRIBING INFORMATION INVEGA TRINZATM ", (20150501), XP093007896-
OPPOSITION- Jambhekar, Sunil S. ; Breen, Philip J., "3.7 Intravenous bolus administration of drugs:summary", Jambhekar, Sunil S. ; Breen, Philip J., SUNIL S JAMBHEKAR AND PHILIP J BREEN, Basic Pharmacokinetics, 2nd edition, PHARMACEUTICAL PRESS, (20120327), page 41, ISBN 978-0-85369-980-4, XP009559638-
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OPPOSITION- Osborne Richard H, Dalton Andrew, Hertel Judy, Schrover Rudolf, Smith Dell Kingsford, "Health-related quality of life advantage of longacting injectable antipsychotic treatment for schizophrenia: a time trade-off study", Health and Quality of Life Outcomes, (20120101), vol. 10, no. 35, XP093210737-
OPPOSITION- Ravenstijn Paulien , Mahesh Samtani , Alberto Russu , David Hough , Srihari Gopal, "Paliperidone Palmitate Long-Acting Injectable Given Intramuscularly in the Deltoid Versus the Gluteal Muscle Are They Therapeutically Equivalent?", Journal of Clynical Psychopharmacology, (20161201), vol. 36, no. 6, pages 744 - 745, XP093217481-
OPPOSITION- Renato Urso, P Blardi, Gustavo Di Giorgi, "A short introduction to pharmacokinetics", European review for medical and pharmacological, (20020301), vol. 6, no. 2-3, pages 33 - 44, XP055732403-
OPPOSITION- Stringer Janet L., "Chapter 4: Pharmacokinetics", Basic Concepts in Pharmacology, 4th ed., MCGRAW-HILL MEDICAL, (20110101), pages 16 - 23, ISBN 978-0-07-176942-6, XP055974115-
OPPOSITION- Stringer Janet L., "Chapter 4: Pharmacokinetics", Stringer Janet L., JANET L. STRINGER, Basic Concepts in Pharmacology, 4th ed., MCGRAW-HILL MEDICAL, (20110101), pages 16 - 23, ISBN 978-0-07-176942-6, XP055974115-
OPPOSITION- SUNIL S JAMBHEKAR, PHILIP J BREEN, "Passage; Basic Pharmacokinetics", Basic Pharmacokinetics, 2nd edition, PHARMACEUTICAL PRESS, (20120101), page 41, ISBN 978-0-85369-980-4, XP055974095-
OPPOSITION- SUNIL S JAMBHEKAR, PHILIP J BREEN, "Passage; Basic Pharmacokinetics", SUNIL S JAMBHEKAR, PHILIP J BREEN, Sunil S. Jambhekar, Philip J. Breen, Basic Pharmacokinetics, 2nd edition, PHARMACEUTICAL PRESS, (20120101), page 41, ISBN 978-0-85369-980-4, XP055974095-
OPPOSITION- Anonymous, "A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3-Month Formulation for the Treatment of Patients with Schizophrenia", Redacted Clinical Protocol for Journal Use; Protocol R092670PSY3012; Phase 3 AMENDMENT INT-4 R092670 (paliperidone palmitate); NCT01529515, (20130725), XP093210708
OPPOSITION- Janssen Research And Development L L C, "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia; Supplemental Content: Redacted Clinical Protocol for Journal Use: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3-Month Formulation for the Treatment of Patients with Schizophrenia Protocol R092670PSY3012; Phase 3", JAMA Psychiatry, American Medical Association, US, US , (20130725), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, pages 1 - 51, XP093159190
OPPOSITION- Janssen Research And Development L L C, "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia; Supplemental Content: Redacted Clinical Protocol for Journal Use: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3-Month Formulation for the Treatment of Patients with Schizophrenia Protocol R092670PSY3012; Phase 3", JAMA Psychiatry, American Medical Association, US, US , (20130725), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, pages 1 - 51, XP093210708
OPPOSITION- Joris Berwaerts, Liu Yanning, Gopal Srihari, Nuamah Isaac, Xu Haiyan, Savitz Adam, Coppola Danielle, Schotte Alain, Remmerie Bart, Maruta Nataliya, Hough David W., "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia : A Randomized Clinical Trial", JAMA Psychiatry, American Medical Association, US, US , (20150801), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, page 830, XP055525842
OPPOSITION- Joris Berwaerts, Liu Yanning, Gopal Srihari, Nuamah Isaac, Xu Haiyan, Savitz Adam, Coppola Danielle, Schotte Alain, Remmerie Bart, Maruta Nataliya, Hough David W., "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia : A Randomized Clinical Trial", JAMA Psychiatry, American Medical Association, US, US , (20150801), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, pages 830 - 839, XP055525842
OPPOSITION- Joris Berwaerts, Liu Yanning, Gopal Srihari, Nuamah Isaac, Xu Haiyan, Savitz Adam, Coppola Danielle, Schotte Alain, Remmerie Bart, Maruta Nataliya, Hough David W., "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia : A Randomized Clinical Trial", JAMA Psychiatry, US , (20150801), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, pages 830 - 839, XP055525842
OPPOSITION- Joris Berwaerts, "Supplementary Online Content: Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia : A Randomized Clinical Trial", JAMA Psychiatry, American Medical Association, US, US , (20150801), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, pages 1 - 17, XP093159183
OPPOSITION- Ravenstijn Paulien, Remmerie Bart, Savitz Adam, Samtani Mahesh N., Nuamah Isaac, Chang Cheng‐tao, De Meulder Marc, Hough David, Gopal Srihari, "Pharmacokinetics, safety, and tolerability of paliperidone palmitate 3‐month formulation in patients with schizophrenia: A phase‐1, single‐dose, randomized, open‐label study", The Journal of clinical pharmacology, LIPPINCOTT CO, HAGERSTOWN, MD, US, US , (20160301), vol. 56, no. 3, doi:10.1002/jcph.597, ISSN 0091-2700, pages 330 - 339, XP093212289
OPPOSITION- Mats O. Magnusson, Mahesh N. Samtani, Elodie L. Plan, E. Niclas Jonsson, Stefaan Rossenu, An Vermeulen & Alberto Russu , "Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia", CLINICAL PHARMACOKINETICS., ADIS INTERNATIONAL LTD., AUCKLAND, NZ, NZ , (20161014), vol. 56, no. 4, doi:10.1007/s40262-016-0459-3, ISSN 0312-5963, pages 421 - 433, XP009557541
OPPOSITION- Berwaerts Joris, Yanning Liu; Srihari Gopal; Isaac Nuamah; Haiyan Xu; Adam Savitz; Danielle Coppola; Alain Schotte; Bart Remmerie; Nataliya Maruta; David W Hough, "Efficacy and Safety of Paliperidone Palmitate 3 month Formulation: A Randomized, Double-blind, Placebo-controlled Study", Schizophrenia Bulletin, Oxford University Press, (20150301), vol. 41, no. Suppl. 1, doi:10.1093/schbul/sbv010, ISSN 0586-7614, pages S302 - S302, XP093212050
OPPOSITION- Anonymous, "College of Psychiatric and Neurologic Pharmacists 2009 Poster Abstracts", JOURNAL OF PHARMACY PRACTICE, TECHNOMIC PUBLISHING CO, US, US , (20090401), vol. 22, no. 2, doi:10.1177/0897190009333553, ISSN 0897-1900, pages 203 - 268, XP093210720
OPPOSITION- Anonymous, "ERRATUM - College of Psychiatric and Neurologic Pharmacists 2009 Poster Abstracts", JOURNAL OF PHARMACY PRACTICE, TECHNOMIC PUBLISHING CO, US, US , (20090401), vol. 22, no. 2, doi:10.1177/0897190009333553, ISSN 0897-1900, pages 1 - 1, XP093210725
OPPOSITION- Gopal, Gassmann Mayer, Palumbo, Samtani, Shiwach, Alphs, "Practical guidance for dosing and switching paliperidone palmitate treatment in patients with schizophrenia", Current Medical Research and Opinion, HANTS, GB, GB , (20091210), vol. 26, no. 2, doi:10.1185/03007990903482772, ISSN 0300-7995, pages 377 - 387, XP009557394
OPPOSITION- Srihari Gopal, An Vermeulen, Partha Nandy, Paulien Ravenstijn, Isaac Nuamah, Jose Antonio Buron Vidal, Joris Berwaerts, Adam Savitz, David Hough, Mahesh N. Samtani, "Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia", Current Medical Research and Opinion, GB , (20151102), vol. 31, no. 11, doi:10.1185/03007995.2015.1085849, ISSN 0300-7995, pages 2043 - 2054, XP055627208
OPPOSITION- Srihari Gopal, An Vermeulen, Partha Nandy, Paulien Ravenstijn, Isaac Nuamah, José Antonio Buron Vidal, Joris Berwaerts, Adam Savitz, David Hough, Mahesh N. Samtani, "Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia", Current Medical Research and Opinion, HANTS, GB, GB , (20151102), vol. 31, no. 11, doi:10.1185/03007995.2015.1085849, ISSN 0300-7995, pages 2043 - 2054, XP055627208
OPPOSITION- Richard H Osborne;Andrew Dalton;Judy Hertel;Rudolf Schrover;Dell Kingsford Smith, "Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study", HEALTH AND QUALITY OF LIFE OUTCOMES, BIOMED CENTRAL, LONDON, GB, GB , (20120402), vol. 10, no. 1, doi:10.1186/1477-7525-10-35, ISSN 1477-7525, page 35, XP021095723
OPPOSITION- Richard H Osborne;Andrew Dalton;Judy Hertel;Rudolf Schrover;Dell Kingsford Smith, "Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study", Health and quality of life outcomes, GB , (20120402), vol. 10, no. 1, doi:10.1186/1477-7525-10-35, ISSN 1477-7525, page 35, XP021095723
OPPOSITION- Pierre Chue, Chue James, "A review of paliperidone palmitate", Expert Review of Neurotherapeutics, Taylor & Francis, (20121209), vol. 12, no. 12, doi:10.1586/ern.12.137, ISSN 1473-7175, pages 1383 - 1397, XP055525726
OPPOSITION- Samtani Cynthia, Sheehan, Fu, Remmerie, Sliwa, Alphs, "Management of antipsychotic treatment discontinuation and interruptions using model-based simulations", Clinical Pharmacology: Advances and Applications, (20120701), vol. 4, doi:10.2147/CPAA.S32735, pages 25 - 40, XP055974109
OPPOSITION- Samtani Mahesh, Nuamah I, Gopal Srihari, Remmerie, Sliwa, Alphs Larry, "Expansion of guidance for the day 8 initiation dose of paliperidone palmitate to avoid a missed dose", Neuropsychiatric Disease and Treatment, doi:10.2147/NDT.S40836, (20130101), pages 721 - 730, Neuropsychiatric Disease and Treatment, URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3665573/pdf/ndt-9-721.pdf, XP055979077
OPPOSITION- Mahesh N. Samtani, Srihari Gopal, Cristiana Gassmann-Mayer, Larry Alphs & Joseph M. Palumbo, "Dosing and Switching Strategies for Paliperidone Palmitate Based on Population Pharmacokinetic Modelling and Clinical Trial Data", CNS Drugs, (20110101), vol. 25, no. 10, pages 829 - 845, XP055760743
OPPOSITION- Mahesh N. Samtani, Srihari Gopal, Cristiana Gassmann-Mayer, Larry Alphs & Joseph M. Palumbo, "Dosing and Switching Strategies for Paliperidone Palmitate Based on Population Pharmacokinetic Modelling and Clinical Trial Data", CNS Drugs, (20111001), vol. 25, no. 10, doi:10.2165/11591690-000000000-00000, pages 829 - 845, XP055760743
OPPOSITION- Samtani Mahesh N., Gopal Srihari, Gassmann-Mayer Cristiana, Alphs Larry, Palumbo Joseph M., "Supplemental Digital Content: Dosing and switching strategies for paliperidone palmitate: based on population pharmacokinetic modelling and clinical trial data", CNS DRUGS, ADIS INTERNATIONAL, AUCKLAND, NZ, AUCKLAND, NZ , (20111001), vol. 25, no. 10, doi:10.2165/11591690-000000000-00000, ISSN 1172-7047, pages 1 - 21, XP093212282
SEARCH- JORIS BERWAERTS ET AL, "Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia : A Randomized Clinical Trial", JAMA PSYCHIATRY, (20150325), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, page 830, XP055525842 [Y] 1-8 * abstract *
SEARCH- RICHARD H OSBORNE ET AL, "Health-related quality of life advantage of long-acting injectable antipsychotic treatment for schizophrenia: a time trade-off study", HEALTH AND QUALITY OF LIFE OUTCOMES, BIOMED CENTRAL, LONDON, GB, (20120402), vol. 10, no. 1, doi:10.1186/1477-7525-10-35, ISSN 1477-7525, page 35, XP021095723 [Y] 1-8 * abstract *
SEARCH- PIERRE CHUE ET AL, "A review of paliperidone palmitate", EXPERT REVIEW OF NEUROTHERAPEUTICS, GB, (20121209), vol. 12, no. 12, doi:10.1586/ern.12.137, ISSN 1473-7175, pages 1383 - 1397, XP055525726 [Y] 1-8 * abstract *

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