CA3203448A1 - Dosing regimens associated with extended release paliperidone injectable formulations - Google Patents

Dosing regimens associated with extended release paliperidone injectable formulations

Info

Publication number
CA3203448A1
CA3203448A1 CA3203448A CA3203448A CA3203448A1 CA 3203448 A1 CA3203448 A1 CA 3203448A1 CA 3203448 A CA3203448 A CA 3203448A CA 3203448 A CA3203448 A CA 3203448A CA 3203448 A1 CA3203448 A1 CA 3203448A1
Authority
CA
Canada
Prior art keywords
dose
paliperidone
pp6m
paliperidone palmitate
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CA3203448A
Other languages
English (en)
French (fr)
Inventor
Srihari Gopal
Raja Venkatasubramanian
Huybrecht T'jollyn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Janssen Pharmaceutica NV
Original Assignee
Janssen Pharmaceutica NV
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=75888042&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA3203448(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Pharmaceutica NV filed Critical Janssen Pharmaceutica NV
Publication of CA3203448A1 publication Critical patent/CA3203448A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K47/06—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (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)
CA3203448A 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations Pending CA3203448A1 (en)

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

Publications (1)

Publication Number Publication Date
CA3203448A1 true CA3203448A1 (en) 2022-06-02

Family

ID=75888042

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3203448A Pending CA3203448A1 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations

Country Status (24)

Country Link
US (2) US11324751B1 (enExample)
EP (2) EP4025187B1 (enExample)
JP (2) JP7792409B2 (enExample)
KR (1) KR20230116837A (enExample)
CN (1) CN116507320A (enExample)
AU (3) AU2021387679B2 (enExample)
CA (1) CA3203448A1 (enExample)
DK (1) DK4025187T3 (enExample)
ES (1) ES2974822T3 (enExample)
FI (1) FI4025187T3 (enExample)
HR (1) HRP20240086T1 (enExample)
HU (1) HUE065387T2 (enExample)
IL (1) IL303251A (enExample)
LT (1) LT4025187T (enExample)
MA (1) MA71365A (enExample)
MX (2) MX2023006370A (enExample)
PL (1) PL4025187T3 (enExample)
PT (1) PT4025187T (enExample)
RS (1) RS65133B1 (enExample)
SI (1) SI4025187T1 (enExample)
SM (1) SMT202400075T1 (enExample)
TW (2) TWI838623B (enExample)
WO (1) WO2022111858A1 (enExample)
ZA (1) ZA202400851B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Family Cites Families (21)

* 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
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
CA2655335C (en) 2007-12-19 2016-09-06 Janssen Pharmaceutica N.V. Prolonged-release injectable suspensions of paliperidone palmitate, and dosage forms and delivery systems incorporating same
US8758780B2 (en) 2009-10-06 2014-06-24 Ascendis Pharma As Subcutaneous paliperidone composition
AU2010313290A1 (en) * 2009-10-30 2012-05-17 Janssen Pharmaceutica Nv Dosing regimen associated with long-acting injectable paliperidone esters
SI2529757T1 (sl) 2011-05-31 2014-05-30 Laboratorios Farmaceuticos Rovi, S.A. Formulacija paliperidon implantata
WO2013063125A1 (en) * 2011-10-24 2013-05-02 Endo Pharmaceuticals Solutions Inc. Implantable drug delivery compositions and methods of treatment thereof
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
DK3744326T3 (da) * 2015-04-07 2024-02-05 Janssen Pharmaceutica Nv Doseringsregime for glemte doser til langtidsvirkende injicerbare paliperidonestere
CN114783258A (zh) 2015-06-19 2022-07-22 詹森药业有限公司 用于药物施用和混合的系统及用于所述系统的适当技术的训练
EP3700531B1 (en) * 2017-10-27 2025-06-25 Geneora Pharma (Shijiazhuang) Co., Ltd. Dosage regimen of paliperidone palmitate extended-release injectable suspension
US20190183896A1 (en) * 2017-12-14 2019-06-20 SpecGx LLC One step milling process for preparing micronized paliperidone esters
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
PL4005555T3 (pl) 2020-11-30 2024-09-02 Janssen Pharmaceutica Nv Sposoby zapewniania ponownego zawieszenia preparatów palmitynianu paliperydonu
EP4025188B1 (en) 2020-11-30 2024-01-10 Janssen Pharmaceutica NV Dosing regimens associated with extended release paliperidone injectable formulations
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

Also Published As

Publication number Publication date
TW202440122A (zh) 2024-10-16
MX2023006370A (es) 2023-08-07
MA71365A (fr) 2025-04-30
RS65133B1 (sr) 2024-02-29
FI4025187T3 (fi) 2024-02-13
AU2024202306A1 (en) 2024-05-02
DK4025187T3 (da) 2024-03-04
EP4385564A2 (en) 2024-06-19
AU2026201895A1 (en) 2026-04-02
JP2023552149A (ja) 2023-12-14
IL303251A (en) 2023-07-01
PT4025187T (pt) 2024-02-28
TWI838623B (zh) 2024-04-11
SI4025187T1 (sl) 2024-03-29
EP4025187A1 (en) 2022-07-13
CN116507320A (zh) 2023-07-28
AU2024202306B2 (en) 2026-01-15
US11324751B1 (en) 2022-05-10
KR20230116837A (ko) 2023-08-04
SMT202400075T1 (it) 2024-03-13
EP4385564A3 (en) 2024-10-09
US20230105276A1 (en) 2023-04-06
ES2974822T3 (es) 2024-07-01
PL4025187T3 (pl) 2024-04-29
TW202222318A (zh) 2022-06-16
HRP20240086T1 (hr) 2024-03-29
JP2026027249A (ja) 2026-02-18
WO2022111858A1 (en) 2022-06-02
ZA202400851B (en) 2025-04-30
AU2021387679A1 (en) 2023-07-20
JP7792409B2 (ja) 2025-12-25
EP4025187B1 (en) 2024-01-03
HUE065387T2 (hu) 2024-05-28
US20220168306A1 (en) 2022-06-02
LT4025187T (lt) 2024-02-12
US12208100B2 (en) 2025-01-28
MX2024013364A (es) 2024-12-06
AU2021387679B2 (en) 2024-01-18
TWI897289B (zh) 2025-09-11

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