AU2021387679B2 - Dosing regimens associated with extended release paliperidone injectable formulations - Google Patents

Dosing regimens associated with extended release paliperidone injectable formulations Download PDF

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Publication number
AU2021387679B2
AU2021387679B2 AU2021387679A AU2021387679A AU2021387679B2 AU 2021387679 B2 AU2021387679 B2 AU 2021387679B2 AU 2021387679 A AU2021387679 A AU 2021387679A AU 2021387679 A AU2021387679 A AU 2021387679A AU 2021387679 B2 AU2021387679 B2 AU 2021387679B2
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AU
Australia
Prior art keywords
dose
pp6m
paliperidone palmitate
paliperidone
patient
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Active
Application number
AU2021387679A
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English (en)
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AU2021387679A1 (en
AU2021387679A9 (en
Inventor
Srihari Gopal
Huybrecht T'jollyn
Raja Venkatasubramanian
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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 AU2021387679A1 publication Critical patent/AU2021387679A1/en
Application granted granted Critical
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Priority to AU2024202306A priority Critical patent/AU2024202306B2/en
Publication of AU2021387679A9 publication Critical patent/AU2021387679A9/en
Priority to AU2026201895A priority patent/AU2026201895A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • 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
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
AU2021387679A 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations Active AU2021387679B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2024202306A AU2024202306B2 (en) 2020-11-30 2024-04-10 Dosing regimens associated with extended release paliperidone injectable formulations
AU2026201895A AU2026201895A1 (en) 2020-11-30 2026-03-12 Dosing regimens associated with extended release paliperidone injectable formulations

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063119382P 2020-11-30 2020-11-30
US63/119,382 2020-11-30
PCT/EP2021/062144 WO2022111858A1 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2024202306A Division AU2024202306B2 (en) 2020-11-30 2024-04-10 Dosing regimens associated with extended release paliperidone injectable formulations

Publications (3)

Publication Number Publication Date
AU2021387679A1 AU2021387679A1 (en) 2023-07-20
AU2021387679B2 true AU2021387679B2 (en) 2024-01-18
AU2021387679A9 AU2021387679A9 (en) 2024-10-17

Family

ID=75888042

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2021387679A Active AU2021387679B2 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations
AU2024202306A Active AU2024202306B2 (en) 2020-11-30 2024-04-10 Dosing regimens associated with extended release paliperidone injectable formulations
AU2026201895A Pending AU2026201895A1 (en) 2020-11-30 2026-03-12 Dosing regimens associated with extended release paliperidone injectable formulations

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2024202306A Active AU2024202306B2 (en) 2020-11-30 2024-04-10 Dosing regimens associated with extended release paliperidone injectable formulations
AU2026201895A Pending AU2026201895A1 (en) 2020-11-30 2026-03-12 Dosing regimens associated with extended release paliperidone injectable formulations

Country Status (24)

Country Link
US (2) US11324751B1 (https=)
EP (2) EP4025187B1 (https=)
JP (2) JP7792409B2 (https=)
KR (1) KR20230116837A (https=)
CN (1) CN116507320A (https=)
AU (3) AU2021387679B2 (https=)
CA (1) CA3203448A1 (https=)
DK (1) DK4025187T3 (https=)
ES (1) ES2974822T3 (https=)
FI (1) FI4025187T3 (https=)
HR (1) HRP20240086T1 (https=)
HU (1) HUE065387T2 (https=)
IL (1) IL303251A (https=)
LT (1) LT4025187T (https=)
MA (1) MA71365A (https=)
MX (2) MX2023006370A (https=)
PL (1) PL4025187T3 (https=)
PT (1) PT4025187T (https=)
RS (1) RS65133B1 (https=)
SI (1) SI4025187T1 (https=)
SM (1) SMT202400075T1 (https=)
TW (2) TWI897289B (https=)
WO (1) WO2022111858A1 (https=)
ZA (1) ZA202400851B (https=)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7839162B2 (ja) 2020-11-30 2026-04-01 ヤンセン ファーマシューティカ エヌ．ベー． パルミチン酸パリペリドン製剤の再懸濁を確実にする方法
ES2981035T3 (es) 2020-11-30 2024-10-07 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada
MX2023006370A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
WO2023030870A1 (en) * 2021-08-30 2023-03-09 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
US20170281629A1 (en) * 2015-04-07 2017-10-05 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US20190183896A1 (en) * 2017-12-14 2019-06-20 SpecGx LLC One step milling process for preparing micronized paliperidone esters

Family Cites Families (16)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5254556A (en) 1988-11-07 1993-10-19 Janssen Pharmaceutica N.V. 3-piperidinyl-1,2-benzisoxazoles
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
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
WO2006114384A1 (en) 2005-04-25 2006-11-02 Janssen Pharmaceutica N.V. Preparation of aseptic 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-9-hydroxy-2-methyl-4h-pyridio[1,2-a]pyrimidin-4-one palmitate ester
KR102318070B1 (ko) 2007-12-19 2021-10-27 얀센 파마슈티카 엔.브이. 장기 작용성 주사가능 팔리페리돈 에스테르와 관련된 투여 요법
WO2011042453A1 (en) 2009-10-06 2011-04-14 Ascendis Pharma As Subcutaneous paliperidone composition
BR112012010195A2 (pt) 2009-10-30 2016-04-26 Janssen Pharmaceutica Nv regime de dosagem associado a ésteres de paliperidona injetável de longa ação
ES2456917T3 (es) 2011-05-31 2014-04-24 Laboratorios Farmacéuticos Rovi, S.A. Formulación de implante de paliperidona
HK1254640A1 (zh) 2015-06-19 2019-07-26 Janssen Pharmaceutica, N.V. 用於药物施用和混合的设备和方法及用於所述设备和方法的适当技术的训练
MX2023006370A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
ES2981035T3 (es) 2020-11-30 2024-10-07 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada
KR102794804B1 (ko) 2020-11-30 2025-04-10 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법
JP7839162B2 (ja) 2020-11-30 2026-04-01 ヤンセン ファーマシューティカ エヌ．ベー． パルミチン酸パリペリドン製剤の再懸濁を確実にする方法
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
WO2023030870A1 (en) 2021-08-30 2023-03-09 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
US20170281629A1 (en) * 2015-04-07 2017-10-05 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US10143693B2 (en) * 2015-04-07 2018-12-04 Janssen Pharmaceuticals, Inc. Dosing regimen for missed doses for long-acting injectable paliperidone esters
US20190183896A1 (en) * 2017-12-14 2019-06-20 SpecGx LLC One step milling process for preparing micronized paliperidone esters

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "lnvega Sustenna Reference ID: 3657038", LNVEGA, 1 November 2014 (2014-11-01), pages 1 - 56, XP055780705, Retrieved from the Internet [retrieved on 20210301] *

Also Published As

Publication number Publication date
DK4025187T3 (da) 2024-03-04
HUE065387T2 (hu) 2024-05-28
MA71365A (fr) 2025-04-30
EP4025187B1 (en) 2024-01-03
JP7792409B2 (ja) 2025-12-25
RS65133B1 (sr) 2024-02-29
TWI897289B (zh) 2025-09-11
LT4025187T (lt) 2024-02-12
SMT202400075T1 (it) 2024-03-13
PT4025187T (pt) 2024-02-28
EP4025187A1 (en) 2022-07-13
US12208100B2 (en) 2025-01-28
TWI838623B (zh) 2024-04-11
CN116507320A (zh) 2023-07-28
FI4025187T3 (fi) 2024-02-13
AU2024202306B2 (en) 2026-01-15
TW202440122A (zh) 2024-10-16
SI4025187T1 (sl) 2024-03-29
HRP20240086T1 (hr) 2024-03-29
CA3203448A1 (en) 2022-06-02
AU2021387679A1 (en) 2023-07-20
AU2026201895A1 (en) 2026-04-02
EP4385564A3 (en) 2024-10-09
MX2024013364A (es) 2024-12-06
IL303251A (en) 2023-07-01
MX2023006370A (es) 2023-08-07
JP2026027249A (ja) 2026-02-18
ZA202400851B (en) 2025-04-30
KR20230116837A (ko) 2023-08-04
WO2022111858A1 (en) 2022-06-02
AU2024202306A1 (en) 2024-05-02
US20230105276A1 (en) 2023-04-06
PL4025187T3 (pl) 2024-04-29
TW202222318A (zh) 2022-06-16
US11324751B1 (en) 2022-05-10
EP4385564A2 (en) 2024-06-19
ES2974822T3 (es) 2024-07-01
US20220168306A1 (en) 2022-06-02
JP2023552149A (ja) 2023-12-14

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