CA2925908C - 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
CA2925908C
CA2925908C CA2925908A CA2925908A CA2925908C CA 2925908 C CA2925908 C CA 2925908C CA 2925908 A CA2925908 A CA 2925908A CA 2925908 A CA2925908 A CA 2925908A CA 2925908 C CA2925908 C CA 2925908C
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CA
Canada
Prior art keywords
dose
reinitiation
patient
paliperidone palmitate
pp3m
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.)
Active
Application number
CA2925908A
Other languages
English (en)
French (fr)
Other versions
CA2925908A1 (en
Inventor
Srihari Gopal
Paulien Gerada Maria Ravenstijn
Alberto Russu
Mahesh Narain Samtani
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 Pharmaceuticals Inc
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
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=57072843&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2925908(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Janssen Pharmaceuticals Inc filed Critical Janssen Pharmaceuticals Inc
Priority to CA3088401A priority Critical patent/CA3088401A1/en
Publication of CA2925908A1 publication Critical patent/CA2925908A1/en
Application granted granted Critical
Publication of CA2925908C publication Critical patent/CA2925908C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

Landscapes

  • 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)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Organic Chemistry (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)
CA2925908A 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters Active CA2925908C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA3088401A CA3088401A1 (en) 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Applications Claiming Priority (4)

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA3088401A Division CA3088401A1 (en) 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Publications (2)

Publication Number Publication Date
CA2925908A1 CA2925908A1 (en) 2016-10-07
CA2925908C true CA2925908C (en) 2020-09-01

Family

ID=57072843

Family Applications (2)

Application Number Title Priority Date Filing Date
CA2925908A Active CA2925908C (en) 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters
CA3088401A Abandoned CA3088401A1 (en) 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA3088401A Abandoned CA3088401A1 (en) 2015-04-07 2016-04-01 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Country Status (27)

Country Link
US (1) US10143693B2 (https=)
EP (3) EP3744326B1 (https=)
JP (3) JP6728221B2 (https=)
KR (3) KR102606678B1 (https=)
AU (4) AU2016244801B2 (https=)
BR (1) BR112017021383A2 (https=)
CA (2) CA2925908C (https=)
CY (1) CY1123203T1 (https=)
DK (2) DK3744326T3 (https=)
EA (1) EA037185B1 (https=)
ES (2) ES2802299T3 (https=)
FI (1) FI3744326T3 (https=)
HR (2) HRP20201027T1 (https=)
HU (2) HUE065435T2 (https=)
IL (3) IL309340B1 (https=)
LT (2) LT3744326T (https=)
MA (1) MA41917B1 (https=)
MD (2) MD3744326T2 (https=)
NZ (1) NZ735952A (https=)
PL (2) PL3744326T3 (https=)
PT (2) PT3280416T (https=)
RS (2) RS65024B1 (https=)
SI (2) SI3280416T1 (https=)
SM (2) SMT202300478T1 (https=)
TW (1) TWI694825B (https=)
UA (1) UA118732C2 (https=)
WO (1) WO2016164218A1 (https=)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016244801B2 (en) 2015-04-07 2020-06-25 Janssen Pharmaceutica Nv Dosing regimen for missed doses for long-acting injectable paliperidone esters
ES3036965T3 (en) * 2017-10-27 2025-09-25 Geneora Pharma Shijiazhuang Co Ltd Dosage regimen of paliperidone palmitate extended-release injectable suspension
IL303254A (en) 2020-11-30 2023-07-01 Janssen Pharmaceutica Nv Methods for ensuring resuspension of paliperidone palmitate formulations
MX2023006368A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
IL303253A (en) * 2020-11-30 2023-07-01 Janssen Pharmaceutica Nv Dosing regimens associated with delayed-release injectable formulations of paliperidone
PL4025187T3 (pl) 2020-11-30 2024-04-29 Janssen Pharmaceutica Nv Schematy dawkowania związane z formulacjami paliperydonu do wstrzykiwania o przedłużonym uwalnianiu
WO2023021008A1 (en) 2021-08-20 2023-02-23 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
IL311134A (en) * 2021-08-30 2024-04-01 Janssen Pharmaceutica Nv Dosing regimens associated with delayed-release paliperidone injection formulations
KR102869809B1 (ko) 2023-11-21 2025-10-13 주식회사 엘지에너지솔루션 양극 및 이를 포함하는 전고체 전지

Family Cites Families (10)

* 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
EP1879890A1 (en) 2005-04-25 2008-01-23 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
BRPI0821408A2 (pt) * 2007-12-19 2015-06-16 Janssen Pharmaceutica Nv Regime de dosagem associado a ésteres de paliperidona injetáveis de longa ação
EP2485712A1 (en) * 2009-10-06 2012-08-15 Ascendis Pharma A/S Subcutaneous paliperidone composition
MX2012005083A (es) * 2009-10-30 2012-09-28 Janssen Pharmaceutica Nv Regimen de dosificacion asociado con esteres de paliperidona inyetables de accion prolongada.
EP2529757B1 (en) * 2011-05-31 2014-01-08 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation
AU2016244801B2 (en) 2015-04-07 2020-06-25 Janssen Pharmaceutica Nv Dosing regimen for missed doses for long-acting injectable paliperidone esters

Also Published As

Publication number Publication date
US20170281629A1 (en) 2017-10-05
LT3744326T (lt) 2023-12-27
ES2967585T3 (es) 2024-05-03
EA201792209A1 (ru) 2018-02-28
SMT202300478T1 (it) 2024-01-10
AU2024227790A1 (en) 2024-11-21
HUE065435T2 (hu) 2024-05-28
SMT202000351T1 (it) 2020-09-10
EP4349323A3 (en) 2024-06-12
CY1123203T1 (el) 2021-10-29
KR20250013293A (ko) 2025-01-31
EP3280416A1 (en) 2018-02-14
JP2021130680A (ja) 2021-09-09
JP7228503B2 (ja) 2023-02-24
KR20230162162A (ko) 2023-11-28
TWI694825B (zh) 2020-06-01
IL254669A0 (en) 2017-11-30
EA037185B1 (ru) 2021-02-17
HRP20240022T1 (hr) 2024-03-29
MD3744326T2 (ro) 2024-05-31
FI3744326T3 (fi) 2024-02-02
JP7422277B2 (ja) 2024-01-26
HK1249047A1 (en) 2018-10-26
KR102606678B1 (ko) 2023-11-24
TW201642863A (zh) 2016-12-16
JP2020090498A (ja) 2020-06-11
JP2018510894A (ja) 2018-04-19
AU2022221405B2 (en) 2024-08-01
PL3744326T3 (pl) 2024-03-25
JP6728221B2 (ja) 2020-07-22
EP4349323A2 (en) 2024-04-10
IL324059A (en) 2025-12-01
SI3744326T1 (sl) 2024-02-29
AU2016244801B2 (en) 2020-06-25
DK3280416T3 (da) 2020-05-11
MA41917B1 (fr) 2020-07-29
KR102755145B1 (ko) 2025-01-14
IL309340B1 (en) 2026-01-01
RS65024B1 (sr) 2024-01-31
DK3744326T3 (da) 2024-02-05
EP3744326B1 (en) 2023-12-06
WO2016164218A1 (en) 2016-10-13
EP3280416A4 (en) 2019-01-23
AU2020239611A1 (en) 2020-10-15
IL309340A (en) 2024-02-01
AU2022221405A1 (en) 2022-09-15
PL3280416T3 (pl) 2020-12-14
MD3280416T2 (ro) 2020-10-31
AU2020239611B2 (en) 2022-07-21
HUE049485T2 (hu) 2020-09-28
PT3744326T (pt) 2024-01-15
PT3280416T (pt) 2020-06-30
US10143693B2 (en) 2018-12-04
IL254669B2 (en) 2024-05-01
NZ758246A (en) 2024-05-31
NZ735952A (en) 2022-02-25
RS60510B1 (sr) 2020-08-31
BR112017021383A2 (pt) 2018-07-03
IL254669B1 (en) 2024-01-01
LT3280416T (lt) 2020-06-25
UA118732C2 (uk) 2019-02-25
KR20170134583A (ko) 2017-12-06
SI3280416T1 (sl) 2020-07-31
ES2802299T3 (es) 2021-01-18
AU2016244801A1 (en) 2017-10-05
CA2925908A1 (en) 2016-10-07
EP3280416B1 (en) 2020-04-22
HRP20201027T1 (hr) 2020-12-11
EP3744326A1 (en) 2020-12-02
CA3088401A1 (en) 2016-10-07

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