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Dosing Regimen For Missed Doses For Long-Acting Injectable Paliperidone Esters - EP3280416

The patent EP3280416 was granted to Janssen Pharmaceutica on Apr 22, 2020. The application was originally filed on Mar 30, 2016 under application number EP16777058A. The patent is currently recorded with a legal status of "Granted And Under Opposition".

EP3280416

JANSSEN PHARMACEUTICA
Application Number
EP16777058A
Filing Date
Mar 30, 2016
Status
Granted And Under Opposition
Mar 20, 2020
Grant Date
Apr 22, 2020
External Links
Slate, Register, Google Patents

Patent Summary

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Patent Family

Patent Oppositions (8)

Patent oppositions filed by competitors challenge the validity of a granted patent. These oppositions are typically based on claims of prior art, lack of novelty, or non-obviousness. They are a key part of the process for determining a patent's strength and enforceability.

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DF MP DORRIES FRANK MOLNIA & POHLMAN PATENTANWALTE RECHTSANWALTE PARG MBBJan 22, 2021ADMISSIBLE
HOFFMANN EITLEJan 22, 2021ADMISSIBLE
STADA ARZNEIMITTELJan 22, 2021ADMISSIBLE
ACCORD HEALTHCAREJan 21, 2021ADMISSIBLE
HEXALJan 21, 2021ADMISSIBLE
TEVA PHARMACEUTICALSJan 21, 2021ADMISSIBLE
HAMM & WITTKOPPJan 19, 2021WITHDRAWN
INSTONEDec 1, 2020ADMISSIBLE

Patent Citations (13) New

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

Citation PhasePublication NumberPublication Link
DESCRIPTIONUS2011105536
DESCRIPTIONUS5254556
DESCRIPTIONUS6077843
DESCRIPTIONUS6555544
DESCRIPTIONWO2006114384
INTERNATIONAL-SEARCH-REPORTEP2529757
INTERNATIONAL-SEARCH-REPORTUS2009163519
INTERNATIONAL-SEARCH-REPORTUS2011105536
INTERNATIONAL-SEARCH-REPORTUS2012277253
OPPOSITIONUS2009163519
OPPOSITIONUS2011105536
OPPOSITIONWO2011053829
OPPOSITIONWO2016164218

Non-Patent Literature (NPL) Citations (25) 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
OPPOSITION- Anonymous, "A Randomized, Multicenter, Double-Blind, Non- inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia", ClinicalTrials.gov, (20120101), ClinicalTrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT01515423?V 40=View#StudyPaqeTop, (20221024), XP055974171-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION For INVEGA® SUSTENNA® (paliperidone palmitate) extended-releaseinjectable suspension, for intramuscular use", U.S. Food and Drug Administration, (20141100), pages 1 - 56, XP055760741-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION For INVEGA® SUSTENNA® (paliperidone palmitate) extended-releaseinjectable suspension, for intramuscular use", U.S. Food and Drug Administration, (20141101), pages 1 - 56, XP055760741-
OPPOSITION- Anonymous, "HIGHLIGHTS OF PRESCRIBING INFORMATION ", Invega Sustenna Patient Leaflet 3657038, (20141101), Invega Sustenna Patient Leaflet 3657038, (20221024), XP055974134-
OPPOSITION- Anonymous, "lnvega Sustenna Reference ID: 3657038", lnvega, (20141100), pages 1 - 56, XP055780705-
OPPOSITION- Anonymous, "Risperdal - HIGHLIGHTS OF PRESCRIBING INFORMATION", (20070801), (20240321), XP093144160-
OPPOSITION- Jambhekar Sunil S, Et Al., "BASIC PHARMACOKINETICS", (20120101), page 41, XP055974095-
OPPOSITION- OSBORNE et al., Health and Quality of Life Outcomes, (20120000), vol. 10, no. 35-
OPPOSITION- Stringer Janet L., "Basic Concepts in Pharmacology. What you need to know for each drug class", (20110101), XP055974115-
OPPOSITION- 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, (20150000), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, 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., (20150329), vol. 72, no. 8, 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, (20150329), vol. 72, no. 8, 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, American Medical Association, US, US , (20150801), vol. 72, no. 8, doi:10.1001/jamapsychiatry.2015.0241, ISSN 2168-622X, page 830, XP055525842
OPPOSITION- GOPAL, S. et al., "Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia", Current medical Research and Opinion, (20150000), vol. 31, doi:10.1185/03007995.2015.1085849, 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- Pierre Chue, Chue James, "A review of paliperidone palmitate", EXPERT REVIEW OF NEUROTHERAPEUTICS, FUTURE DRUGS, LONDON, GB, GB , (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 1, 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, 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, (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, pages 829 - 845, XP055760743
OPPOSITION- SAMTANI et al., "Dosing and Switching Strategies for Paliperidone Palmitate. Based on Population Pharmacokinetic Modelling and Clinical Trial Data", CNS Drugs, (20110000), vol. 25, no. 10, pages 829 - 845, XP055760743
OPPOSITION- SAMTANI, M.-N. et al., "Dosing and switching strategies for paliperidone palmitate", CNS Drugs, (20110000), vol. 25, pages 829 - 845, XP055760743
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- 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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