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Dosing Regimen Associated With Long Acting Injectable Paliperidone Esters - EP2234617

The patent EP2234617 was granted to Janssen Pharmaceutica on Nov 6, 2024. The application was originally filed on Dec 17, 2008 under application number EP08863534A. The patent is currently recorded with a legal status of "Patent Maintained As Amended".

EP2234617

JANSSEN PHARMACEUTICA
Application Number
EP08863534A
Filing Date
Dec 17, 2008
Status
Patent Maintained As Amended
Oct 3, 2024
Publication Date
Nov 6, 2024
External Links
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Patent Summary

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EGISDec 31, 2021STOLMAR & PARTNERWITHDRAWN
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ABBOTTDec 20, 2021REDDIE & GROSEWITHDRAWN
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Patent Citations (17) New

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

Citation PhasePublication Number
EXAMINATIONUS2003064998
INTERNATIONAL-SEARCH-REPORTUS2007197591
OPPOSITIONEP0904081
OPPOSITIONEP1033987
OPPOSITIONUS2006079846
OPPOSITIONUS20070014918P
OPPOSITIONUS2007197591
OPPOSITIONUS20080120276P
OPPOSITIONUS5254556
OPPOSITIONUS6077843
OPPOSITIONUS6555544
OPPOSITIONWO2004018312
OPPOSITIONWO2006114384
OPPOSITIONWO2009080651
OPPOSITIONWO9744039
OPPOSITIONWO9925354
OTHERUS6555544

Non-Patent Literature (NPL) Citations (134) 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
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OPPOSITION- Anonymous, "A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia NCT00210548", Clinicaltrials.gov NCT00210548, (20071011), pages 1 - 6, Clinicaltrials.gov NCT00210548, URL: https://clinicaltrials.gov/ct2/show/NCT00210548, (20210423), XP055798506
OPPOSITION- ANONYMOUS, "A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia NCT00210548", CLINICALTRIALS.GOV NCT00210548, (20071011), pages 1 - 6, XP055798506
OPPOSITION- Anonymous, "CENTER FOR DRUG EVALUATION AND RESEARCH 22-264 APPROVAL LETTER DEPARTMENT OF HEALTH AND HUMAN Public Health Service NDA 22-264 NDA APPROVAL", FDA Summery Review 22-264, (20090307), pages 1 - 7, FDA Summery Review 22-264, URL: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022264s000Approv.pdf, (20210423), XP055798510
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OPPOSITION- Anonymous, "Clinical Study Report Synopsis Protocol No.: CR002350 relating to trial NCT00119756", ClinicalTrials, (20070731), pages 1 - 5, ClinicalTrials, URL: www.clinicaltrials.gov, (20220111), XP055877512
OPPOSITION- Anonymous, "Clinical Trials: A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia", Internet Archive Wayback Machine, (20060621), pages 1 - 4, Internet Archive Wayback Machine, URL: https://web.archive.org/web/20060621093706/https://clinicaltrials.gov/ct/show/NCT00210548, (20220331), XP055907513
OPPOSITION- Anonymous, "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry", US department of Health and Human Services, (20180301), pages 1 - 69, US department of Health and Human Services, URL: https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/19400977fnl.pdf, (20211220), XP055874757
OPPOSITION- Anonymous, "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100mg eq., and 150 mg eq.) of Paliperidone Palmitate in patients with Schizophrenia", ClinicalTrials.gov Identifier: NCT00590577, (20081113), pages 1 - 9, XP055798515
OPPOSITION- Anonymous, "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia", ClinicalTrials.gov Identifier: NCT00590577, (20081113), pages 1 - 9, XP055798515
OPPOSITION- Anonymous, "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia /ClinicalTrials.gov/", Internet Archive Wayback Machine, (20081014), pages 1 - 3, Internet Archive Wayback Machine, URL: https://web.archive.org/web/20081014164744/https://clinicaltrials.gov/ct2/show/NCT00590577, (20220113), XP055878891
OPPOSITION- Anonymous, "Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia NCT00590577", ClinicalTrials.gov NCT00590577, (20081113), pages 1 - 9, ClinicalTrials.gov NCT00590577, URL: https://clinicaltrials.gov/ct2/show/NCT00590577, (20210423), XP055798515
OPPOSITION- Anonymous, "Elan Corporation PLC Announces the Johnson and Johnson Pharmaceutical Research and Development, LLC (CA) Submission of a New Drug Application to the FDA ", BioSpace, (20071029), pages 1 - 2, BioSpace, URL: https://www.biospace.com/article/releases/elan-corporation-plc-announces-the-johnson-and-johnson-pharmaceutical-research-and-development-llc-ca-submission-of-a-new-drug-application-to-the-f/, (20220118), XP055880444
OPPOSITION- Anonymous, "History of Changes for Study: NCT00210548 A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia", clinicaltrials.gov, (20071011), pages 1 - 4, clinicaltrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT00210548?A=14&B=14&C=merged#StudyPageTop, (20220113), XP055878905
OPPOSITION- Anonymous, "History of Changes for Study: NCT00210548 A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia", ClinicalTrials.gov NCT00210548, (20060526), pages 1 - 5, XP055907503
OPPOSITION- Anonymous, "History of Changes for Study: NCT00590577 Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in P Schizophrenia ", clinicaltrials.gov, (20081113), pages 1 - 5, clinicaltrials.gov, URL: https://clinicaltrials.gov/ct2/history/NCT00590577?A=4&B=4&C=merged#StudyPageTop, (20220113), XP055878912
OPPOSITION- ANONYMOUS, "INVEGAâ„¢ (paliperidone) Extended-Release Tablets", FDA Invega@ label, (20070927), pages 1 - 5, URL: https://web.archive.org/web/20070929081656if_/http://www.invega.com/invega/shared/pi/invega.pdf, XP055890538
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OPPOSITION- ANONYMOUS, "Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate | Johnson & Johnson", New Releases, (20071029), pages 1 - 3, URL: https://johnsonandjohnson.gcs-web.com, XP055798530
OPPOSITION- Anonymous L, "History of Changes for Study: NCT00210548 A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia", ClinicalTrials.gov archive, NIH, (20061011), ClinicalTrials.gov archive, (20211007), XP055849006
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OPPOSITION- "ASSESSMENT OF THE DOSE PROPORTIONALITY OF PALIPERIDONE PALMITATE 25, 50, 100 AND 150 MG EQ., A NEW LONG-ACTING INJECTABLE ANTIPSYCHOTIC FOLLOWING ADMINISTRATION IN THE DELTOID OR GLUTEAL MUSCLES.'' and PI-75 ''EVALUATION OF THE PHARMACOKINETIC PROFILE OF GLUTEAL VERSUS DELTOID INTRAMUSCULAR INJECTIONS OF PALIPERIDONE PALMITATE 100 MG EQUIVALENT IN PATIENTS WITH SCHIZOPHRENIA", Clin Pharm & Ther, (20080300), vol. 83, no. suppl. 1
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OPPOSITION- CLETON A. et al., "Assessment of the dose propor- tionality of paliperidone palmitate 25, 50, 100 and 150 mg-eq., a new long-acting injectable antipsychotic following admin- istration in the deltoid or gluteal muscles", Clinical Pharmacology and Therapeutics, (20080301), vol. 83, no. Suppl. 1, XP009131520
OPPOSITION- Cleton A et al, "Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg EQ. A new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles.", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20080405), vol. 83, no. suppl 1., ISSN 0009-9236, page S31, XP009131520
OPPOSITION- CLETON A. et al., "Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg EQ. A new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles", Clin Pharm & Ther., (20080301), vol. 83, page S31, XP009131520
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OPPOSITION- CLETON A. et al., "Effects of renal impairment on the pharmacokinetic profile of paliperidone extended-release tablets", Clinical Pharmacology and Therapeutics, (20070301), vol. 81, no. 1, page S63, XP009114090
OPPOSITION- Cleton A; et al, "Effects of renal impairment on the pharmacokinetic profile of paliperidone extended-release tablets", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20070301), vol. 81, no. Suppl. 1, ISSN 0009-9236, page 63, XP008097094
OPPOSITION- Cleton A; et al, "Effects of renal impairment on the pharmacokinetic profile of paliperidone extended-release tablets", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US, (20070301), vol. 81, no. Suppl. 1, ISSN 0009-9236, page 63, XP008097094
OPPOSITION- CLETON A. et al., "EFFECTS OF RENAL IMPAIRMENT ON THE PHARMACOKINETIC PROFILE OF PALIPERIDONE EXTENDED RELEASE TABLETS", Clin Pharm & Ther, (20070300), vol. 81, no. suppl. 1, XP008097094
OPPOSITION- CLETON A. et al., "Effects of renal impairment on the pharmacokinetic profile of paliperidone extended-release tablets", Clin Pharm & Ther, (20070301), vol. 81, page S63, XP008097094
OPPOSITION- Cleton A; Rossenu S; Hough D; Crauwels H; Berwaerts J; Gopal S; Vandebosch A; Fernandez C Rosso, "Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg EQ. A new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles.", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20080405), vol. 83, no. suppl 1., ISSN 0009-9236, page S31, XP009131520
OPPOSITION- Cleton A; Rossenu S; Hough D; Crauwels H; Berwaerts J; Gopal S; Vandebosch A; Fernandez C Rosso, "Assessment of the dose proportionality of paliperidone palmitate 25, 50, 100 and 150 mg EQ. A new long-acting injectable antipsychotic following administration in the deltoid or gluteal muscles.", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US, (20080405), vol. 83, no. suppl 1., ISSN 0009-9236, page S31, XP009131520
OPPOSITION- Cleton A, Rossenu S, Hough D, Crauwels H, Berwaerts J, Gopal S, Vandebosch A, Fernandez C Rosso, Johnso·n Johnson &, "Evaluation of the pharmacokinetic profile of gluteal versus deltoid intramuscular injections of paliperidone palmitate 100 mg equivalent in patients with schizophrenia.", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20080301), vol. 83, no. Suppl. 1 PI-75, ISSN 0009-9236, page S31, XP055846604
OPPOSITION- Cleton A, Rossenu S, Hough D, Crauwels H, Berwaerts J, Gopal S, Vandebosch A, Fernandez C Rosso, "PI-75 Evaluation of the pharmacokinetic profile of gluteal versus deltoid intramuscular injections of paliperidone palmitate 100 mg equivalent in patients with schizophrenia.", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20080301), vol. 83, no. Suppl. 1, ISSN 0009-9236, page S31, XP055846604
OPPOSITION- Cleton A., S. Rossenu D. Hough, H. Crauwels, J. Berwaerts, "PI-74 ASSESSMENT OF THE DOSE PROPORTIONALITY OF PALL PERIDONF PALMITATE 25, 50, 100 AND 150 MG EQ , A NEW LONG-ACTING INJECTABLE ANTIPSYCHOTIC FOLLOWINGADMINISTRATION IN THE DELTOID OR GLUTEAL MUSCLES", Clinical Pharmacology & Therapeutics, (20080301), vol. 81, no. 1S, page S31, XP055880397
OPPOSITION- Cleton A; Thijssen A; van Osselaer N; Boom S; Molz K; Janssens L; Eerdekens M E, "Effects of renal impairment on the pharmacokinetic profile of paliperidone extended-release tablets", Clinical Pharmacology and Therapeutics, Nature Publishing Group, US, US , (20070301), vol. 81, no. Suppl. 1, ISSN 0009-9236, page S63, XP009114090
OPPOSITION- D. HOUGH et al., "Paliperidone Palmitate, an Injectable Antipsychotic, in Prevention of Symptom Recurrence in Patients with Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study", Biol Psych, (20080000), vol. 63, page 285S, XP055798526
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OPPOSITION- Emea, "ICH Topic E 6 (R1) Guideline for Good Clinical Practice", European Medicines Agency, (20020701), pages 1 - 48, European Medicines Agency, URL: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e6-r1-guideline-good-clinical-practice_en.pdf, (20220124), XP055882590
OPPOSITION- FDA, "Invega® (Paliperidone) Extended-Release tablets", Highlights of prescribing information, (20071200), pages 1 - 29, URL: https://www.accessdata.fda.gov/, XP055882611
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OPPOSITION- Gopal Srihari, Et Al, "Safety and Tolerability of the Investigational Antipsychotic Paliperidone Palmitate Injected in the Deltoid or Gluteus Muscle in Patients with Schizophrenia", Biol Psych, (20080101), vol. 63, page 285s, XP055874751
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OPPOSITION- Hough David, "901 Paliperidone Palmitate, an injectable Antipsychotic, in prevention of Symptom Recurrence in Patients with Schizophrenia: A randomized, Double-blind, Placebo-Controlled Study", Biol Psychiatry, (20080101), vol. 63, pages 285S - 286S, XP055798526
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OPPOSITION- J M Kane, E Aguglia, A C Altamura, J L Ayuso Gutierrez, N Brunello, W W Fleischhacker, W Gaebel, J Gerlach, J D Guelfi, W Kissling, Y D Lapierre, E Lindström, J Mendlewicz, G Racagni, L S Carulla, N R Schooler, "Guidelines for depot antipsychotic treatment in schizophrenia", European Neuropsychopharmacology, (19980201), vol. 8, no. 1, pages 55 - 66, XP055910121
OPPOSITION- JOHNSON et al., Johnson & Johnson Pharmaceutical Research & Development Submits New Drug Application for Paliperidone Palmitate, (20071029), XP055798530
OPPOSITION- J.P. Lindenmayer, "Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia", SYNOPSIS Document No.: EDMS-PSDB-8557157:2.0, (20080912), XP055907487
OPPOSITION- Kamienski Mary, Et Al, "Drug action and drug interaction chapter 2", PHARMACOLOGY DEMYSTIFIED, (20060111), pages 1 - 22, XP055876145
OPPOSITION- Kamienski Mary, Et Al, "Drug Action and Drug Interactions", Pharmacology Demystified, mcGraw-Hill , (20060101), pages 23 - 40, XP055798485
OPPOSITION- Kamienski Mary, Et Al, "Drug Action and Drug Interactions", Pharmacology Demystified, mcGraw-Hill, (20060101), pages 23 - 40, XP055798485
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