AU2016244801B2 - Dosing regimen for missed doses for long-acting injectable paliperidone esters - Google Patents

Dosing regimen for missed doses for long-acting injectable paliperidone esters Download PDF

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Publication number
AU2016244801B2
AU2016244801B2 AU2016244801A AU2016244801A AU2016244801B2 AU 2016244801 B2 AU2016244801 B2 AU 2016244801B2 AU 2016244801 A AU2016244801 A AU 2016244801A AU 2016244801 A AU2016244801 A AU 2016244801A AU 2016244801 B2 AU2016244801 B2 AU 2016244801B2
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AU
Australia
Prior art keywords
day
paliperidone palmitate
dose
patient
administering
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AU2016244801A
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English (en)
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AU2016244801A1 (en
Inventor
Srihari Gopal
Paulien Gerarda Maria RAVENSTIJN
Alberto Russu
Mahesh Narain Samtani
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Janssen Pharmaceutica NV
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Janssen Pharmaceutica NV
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Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Publication of AU2016244801A1 publication Critical patent/AU2016244801A1/en
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Priority to AU2020239611A priority Critical patent/AU2020239611B2/en
Assigned to JANSSEN PHARMACEUTICA NV reassignment JANSSEN PHARMACEUTICA NV Request for Assignment Assignors: Janssen Pharmaceuticals, Inc.
Priority to AU2022221405A priority patent/AU2022221405B2/en
Priority to AU2024227790A priority patent/AU2024227790A1/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Dermatology (AREA)
  • Psychiatry (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurology (AREA)
  • Inorganic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2016244801A 2015-04-07 2016-03-30 Dosing regimen for missed doses for long-acting injectable paliperidone esters Active AU2016244801B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2020239611A AU2020239611B2 (en) 2015-04-07 2020-09-21 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2022221405A AU2022221405B2 (en) 2015-04-07 2022-08-23 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2024227790A AU2024227790A1 (en) 2015-04-07 2024-10-31 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201562144054P 2015-04-07 2015-04-07
US62/144,054 2015-04-07
US201562162596P 2015-05-15 2015-05-15
US62/162,596 2015-05-15
PCT/US2016/024841 WO2016164218A1 (en) 2015-04-07 2016-03-30 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2020239611A Division AU2020239611B2 (en) 2015-04-07 2020-09-21 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Publications (2)

Publication Number Publication Date
AU2016244801A1 AU2016244801A1 (en) 2017-10-05
AU2016244801B2 true AU2016244801B2 (en) 2020-06-25

Family

ID=57072843

Family Applications (4)

Application Number Title Priority Date Filing Date
AU2016244801A Active AU2016244801B2 (en) 2015-04-07 2016-03-30 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2020239611A Active AU2020239611B2 (en) 2015-04-07 2020-09-21 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2022221405A Active AU2022221405B2 (en) 2015-04-07 2022-08-23 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2024227790A Pending AU2024227790A1 (en) 2015-04-07 2024-10-31 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Family Applications After (3)

Application Number Title Priority Date Filing Date
AU2020239611A Active AU2020239611B2 (en) 2015-04-07 2020-09-21 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2022221405A Active AU2022221405B2 (en) 2015-04-07 2022-08-23 Dosing regimen for missed doses for long-acting injectable paliperidone esters
AU2024227790A Pending AU2024227790A1 (en) 2015-04-07 2024-10-31 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Country Status (27)

Country Link
US (1) US10143693B2 (enExample)
EP (3) EP3280416B1 (enExample)
JP (3) JP6728221B2 (enExample)
KR (3) KR102755145B1 (enExample)
AU (4) AU2016244801B2 (enExample)
BR (1) BR112017021383A2 (enExample)
CA (2) CA3088401A1 (enExample)
CY (1) CY1123203T1 (enExample)
DK (2) DK3744326T3 (enExample)
EA (1) EA037185B1 (enExample)
ES (2) ES2802299T3 (enExample)
FI (1) FI3744326T3 (enExample)
HR (2) HRP20201027T1 (enExample)
HU (2) HUE065435T2 (enExample)
IL (3) IL254669B2 (enExample)
LT (2) LT3744326T (enExample)
MA (1) MA41917B1 (enExample)
MD (2) MD3280416T2 (enExample)
NZ (1) NZ735952A (enExample)
PL (2) PL3280416T3 (enExample)
PT (2) PT3744326T (enExample)
RS (2) RS65024B1 (enExample)
SI (2) SI3280416T1 (enExample)
SM (2) SMT202000351T1 (enExample)
TW (1) TWI694825B (enExample)
UA (1) UA118732C2 (enExample)
WO (1) WO2016164218A1 (enExample)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DK3744326T3 (da) 2015-04-07 2024-02-05 Janssen Pharmaceutica Nv Doseringsregime for glemte doser til langtidsvirkende injicerbare paliperidonestere
EP3700531B1 (en) 2017-10-27 2025-06-25 Geneora Pharma (Shijiazhuang) Co., Ltd. Dosage regimen of paliperidone palmitate extended-release injectable suspension
EP4025188B1 (en) * 2020-11-30 2024-01-10 Janssen Pharmaceutica NV Dosing regimens associated with extended release paliperidone injectable formulations
PL4005555T3 (pl) 2020-11-30 2024-09-02 Janssen Pharmaceutica Nv Sposoby zapewniania ponownego zawieszenia preparatów palmitynianu paliperydonu
SI4025187T1 (sl) 2020-11-30 2024-03-29 Janssen Pharmaceutica Nv Režimi odmerjanja, povezani s formulacijami paliperidona za injiciranje s podaljšanim sproščanjem
CN116528836A (zh) 2020-11-30 2023-08-01 詹森药业有限公司 与延长释放帕潘立酮可注射制剂相关的给药方案
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
CA3230291A1 (en) * 2021-08-30 2023-03-09 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
KR102869809B1 (ko) 2023-11-21 2025-10-13 주식회사 엘지에너지솔루션 양극 및 이를 포함하는 전고체 전지
CN121914111A (zh) * 2026-03-27 2026-04-24 济南大学 一种小粒度棕榈酸帕利哌酮的结晶工艺

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090163519A1 (en) * 2007-12-19 2009-06-25 An Vermeulen Dosing regimen associated with long acting injectable paliperidone esters
US20110105536A1 (en) * 2009-10-30 2011-05-05 Lewyn-Briscoe Peter H Dosing regimen associated with long-acting injectable paliperidone esters
US20120277253A1 (en) * 2009-10-06 2012-11-01 Sprogoee Kennett Subcutaneous paliperidone composition
EP2529757A1 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation

Family Cites Families (6)

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US5158952A (en) 1988-11-07 1992-10-27 Janssen Pharmaceutica N.V. 3-[2-[4-(6-fluoro-1,2-benzisoxozol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9 tetrahydro-9-hydroxy-2-methyl-4H-pyrido [1,2-a]pyrimidin-4-one, compositions and method of use
US5254556A (en) 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
TW487572B (en) 1996-05-20 2002-05-21 Janssen Pharmaceutica Nv Aqueous suspensions of 9-hydroxyrisperidone fatty acid esters
UA72189C2 (uk) 1997-11-17 2005-02-15 Янссен Фармацевтика Н.В. Фармацевтична композиція, що містить водну суспензію субмікронних ефірів 9-гідроксирисперидон жирних кислот
CN101163702B (zh) 2005-04-25 2011-09-07 詹森药业有限公司 制备无菌的3-[2-[4-(6-氟-1,2-苯并异唑-3-基)-1-哌啶基]乙基]-6,7,8,9-四氢-9-羟基-2-甲基-4H-吡啶并[1,2-a]嘧啶-4-酮棕榈酸酯的方法
DK3744326T3 (da) 2015-04-07 2024-02-05 Janssen Pharmaceutica Nv Doseringsregime for glemte doser til langtidsvirkende injicerbare paliperidonestere

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090163519A1 (en) * 2007-12-19 2009-06-25 An Vermeulen Dosing regimen associated with long acting injectable paliperidone esters
US20120277253A1 (en) * 2009-10-06 2012-11-01 Sprogoee Kennett Subcutaneous paliperidone composition
US20110105536A1 (en) * 2009-10-30 2011-05-05 Lewyn-Briscoe Peter H Dosing regimen associated with long-acting injectable paliperidone esters
EP2529757A1 (en) * 2011-05-31 2012-12-05 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation

Non-Patent Citations (1)

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Title
OSBORNE et al., "Health-related quality of life advantage of longacting injectable antipsychotic treatment for schizophrenia: a time trade-off study", Health and Quality of Life Outcomes, (2012-04-02), vol. 10, no. 1, pages 1 - 9 *

Also Published As

Publication number Publication date
AU2022221405A1 (en) 2022-09-15
KR20230162162A (ko) 2023-11-28
NZ735952A (en) 2022-02-25
EA201792209A1 (ru) 2018-02-28
MA41917B1 (fr) 2020-07-29
JP7228503B2 (ja) 2023-02-24
PL3744326T3 (pl) 2024-03-25
MD3744326T2 (ro) 2024-05-31
AU2020239611B2 (en) 2022-07-21
EP3744326B1 (en) 2023-12-06
NZ758246A (en) 2024-05-31
TWI694825B (zh) 2020-06-01
MD3280416T2 (ro) 2020-10-31
HUE049485T2 (hu) 2020-09-28
IL254669B2 (en) 2024-05-01
EA037185B1 (ru) 2021-02-17
WO2016164218A1 (en) 2016-10-13
IL324059A (en) 2025-12-01
IL309340A (en) 2024-02-01
KR102755145B1 (ko) 2025-01-14
IL254669B1 (en) 2024-01-01
RS65024B1 (sr) 2024-01-31
HRP20201027T1 (hr) 2020-12-11
JP2018510894A (ja) 2018-04-19
JP2021130680A (ja) 2021-09-09
CY1123203T1 (el) 2021-10-29
ES2802299T3 (es) 2021-01-18
US20170281629A1 (en) 2017-10-05
AU2022221405B2 (en) 2024-08-01
TW201642863A (zh) 2016-12-16
EP3744326A1 (en) 2020-12-02
SI3744326T1 (sl) 2024-02-29
EP3280416A4 (en) 2019-01-23
AU2020239611A1 (en) 2020-10-15
UA118732C2 (uk) 2019-02-25
AU2016244801A1 (en) 2017-10-05
KR20250013293A (ko) 2025-01-31
JP7422277B2 (ja) 2024-01-26
CA3088401A1 (en) 2016-10-07
CA2925908C (en) 2020-09-01
BR112017021383A2 (pt) 2018-07-03
LT3280416T (lt) 2020-06-25
SI3280416T1 (sl) 2020-07-31
EP3280416B1 (en) 2020-04-22
ES2967585T3 (es) 2024-05-03
EP3280416A1 (en) 2018-02-14
HRP20240022T1 (hr) 2024-03-29
DK3744326T3 (da) 2024-02-05
IL309340B1 (en) 2026-01-01
JP6728221B2 (ja) 2020-07-22
DK3280416T3 (da) 2020-05-11
KR20170134583A (ko) 2017-12-06
PT3280416T (pt) 2020-06-30
EP4349323A2 (en) 2024-04-10
CA2925908A1 (en) 2016-10-07
IL254669A0 (en) 2017-11-30
RS60510B1 (sr) 2020-08-31
AU2024227790A1 (en) 2024-11-21
PL3280416T3 (pl) 2020-12-14
SMT202300478T1 (it) 2024-01-10
SMT202000351T1 (it) 2020-09-10
EP4349323A3 (en) 2024-06-12
FI3744326T3 (fi) 2024-02-02
JP2020090498A (ja) 2020-06-11
KR102606678B1 (ko) 2023-11-24
HK1249047A1 (en) 2018-10-26
LT3744326T (lt) 2023-12-27
HUE065435T2 (hu) 2024-05-28
US10143693B2 (en) 2018-12-04
PT3744326T (pt) 2024-01-15

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Owner name: JANSSEN PHARMACEUTICA NV

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