JP7792409B2 - 持続放出パリペリドン注射可能製剤に関連する投与レジメン - Google Patents

持続放出パリペリドン注射可能製剤に関連する投与レジメン

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Publication number
JP7792409B2
JP7792409B2 JP2023532443A JP2023532443A JP7792409B2 JP 7792409 B2 JP7792409 B2 JP 7792409B2 JP 2023532443 A JP2023532443 A JP 2023532443A JP 2023532443 A JP2023532443 A JP 2023532443A JP 7792409 B2 JP7792409 B2 JP 7792409B2
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JP
Japan
Prior art keywords
dose
paliperidone
paliperidone palmitate
pp6m
administration
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
JP2023532443A
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English (en)
Japanese (ja)
Other versions
JP2023552149A (ja
JP2023552149A5 (OSRAM
Inventor
ゴパール，シュリハリ
ヴェンカタサブラマニアン，ラジャ
ティージョリン，ユイブレシュト
Original Assignee
ヤンセン ファーマシューティカ エヌ．ベー．
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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=JP7792409(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by ヤンセン ファーマシューティカ エヌ．ベー． filed Critical ヤンセン ファーマシューティカ エヌ．ベー．
Publication of JP2023552149A publication Critical patent/JP2023552149A/ja
Publication of JP2023552149A5 publication Critical patent/JP2023552149A5/ja
Priority to JP2025172891A priority Critical patent/JP2026027249A/ja
Application granted granted Critical
Publication of JP7792409B2 publication Critical patent/JP7792409B2/ja
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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)
  • 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)
  • Oil, Petroleum & Natural Gas (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (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)
JP2023532443A 2020-11-30 2021-05-07 持続放出パリペリドン注射可能製剤に関連する投与レジメン Active JP7792409B2 (ja)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2025172891A JP2026027249A (ja) 2020-11-30 2025-10-14 持続放出パリペリドン注射可能製剤に関連する投与レジメン

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
JP2025172891A Division JP2026027249A (ja) 2020-11-30 2025-10-14 持続放出パリペリドン注射可能製剤に関連する投与レジメン

Publications (3)

Publication Number Publication Date
JP2023552149A JP2023552149A (ja) 2023-12-14
JP2023552149A5 JP2023552149A5 (OSRAM) 2024-05-17
JP7792409B2 true JP7792409B2 (ja) 2025-12-25

Family

ID=75888042

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2023532443A Active JP7792409B2 (ja) 2020-11-30 2021-05-07 持続放出パリペリドン注射可能製剤に関連する投与レジメン
JP2025172891A Pending JP2026027249A (ja) 2020-11-30 2025-10-14 持続放出パリペリドン注射可能製剤に関連する投与レジメン

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2025172891A Pending JP2026027249A (ja) 2020-11-30 2025-10-14 持続放出パリペリドン注射可能製剤に関連する投与レジメン

Country Status (24)

Country Link
US (2) US11324751B1 (OSRAM)
EP (2) EP4385564A3 (OSRAM)
JP (2) JP7792409B2 (OSRAM)
KR (1) KR20230116837A (OSRAM)
CN (1) CN116507320A (OSRAM)
AU (3) AU2021387679B2 (OSRAM)
CA (1) CA3203448A1 (OSRAM)
DK (1) DK4025187T3 (OSRAM)
ES (1) ES2974822T3 (OSRAM)
FI (1) FI4025187T3 (OSRAM)
HR (1) HRP20240086T1 (OSRAM)
HU (1) HUE065387T2 (OSRAM)
IL (1) IL303251A (OSRAM)
LT (1) LT4025187T (OSRAM)
MA (1) MA71365A (OSRAM)
MX (2) MX2023006370A (OSRAM)
PL (1) PL4025187T3 (OSRAM)
PT (1) PT4025187T (OSRAM)
RS (1) RS65133B1 (OSRAM)
SI (1) SI4025187T1 (OSRAM)
SM (1) SMT202400075T1 (OSRAM)
TW (2) TWI838623B (OSRAM)
WO (1) WO2022111858A1 (OSRAM)
ZA (1) ZA202400851B (OSRAM)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2023006370A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
CA3203015A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
CN116528837B (zh) 2020-11-30 2025-03-14 詹森药业有限公司 用于确保棕榈酸帕潘立酮制剂再悬浮的方法
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
AU2022337993A1 (en) * 2021-08-30 2024-04-11 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Citations (3)

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Publication number Priority date Publication date Assignee Title
JP2013509435A (ja) 2009-10-30 2013-03-14 ヤンセン ファーマシューティカ エヌ．ベー． 長時間作用型注入可能パリペリドンエステルに関連した投与レジメン
JP2018510894A (ja) 2015-04-07 2018-04-19 ヤンセン ファーマシューティカルズ，インコーポレーテッド 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン
JP2018520382A (ja) 2015-06-19 2018-07-26 ヤンセン ファーマシューティカ エヌ．ベー． 薬物の投与及び混合のための装置及び方法、並びにそのための適切な技法のトレーニング

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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
JP5249748B2 (ja) 2005-04-25 2013-07-31 ジヤンセン・フアーマシユーチカ・ナームローゼ・フエンノートシヤツプ 無菌３−［２−［４−（６−フルオロ−１，２−ベンズイソオキサゾール−３−イル）−１−ピペリジニル］エチル］−６，７，８，９−テトラヒドロ−９−ヒドロキシ−２−メチル−４Ｈ−ピリド［１，２−ａ］ピリミジン−４−オンパルミチン酸エステルの製造
CN101932327A (zh) 2007-12-19 2010-12-29 詹森药业有限公司 与长效注射用帕潘立酮酯相关的给药方案
WO2011042453A1 (en) 2009-10-06 2011-04-14 Ascendis Pharma As Subcutaneous paliperidone composition
EP2529757B1 (en) 2011-05-31 2014-01-08 Laboratorios Farmaceuticos Rovi, S.A. Paliperidone implant formulation
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
ES3037855T3 (en) * 2017-12-14 2025-10-08 SpecGx LLC One step milling process for preparing micronized paliperidone esters
SMT202400077T1 (it) 2020-11-30 2024-03-13 Janssen Pharmaceutica Nv Regimi di dosaggio associati con formulazioni iniettabili di paliperidone a rilascio prolungato
MX2023006370A (es) 2020-11-30 2023-08-07 Janssen Pharmaceutica Nv Regimenes de dosificacion asociados con formulaciones inyectables de paliperidona de liberacion prolongada.
CA3203015A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
CN116528837B (zh) 2020-11-30 2025-03-14 詹森药业有限公司 用于确保棕榈酸帕潘立酮制剂再悬浮的方法
MX2024002215A (es) 2021-08-20 2024-05-10 Janssen Pharmaceutica Nv Regímenes de dosificación asociados con formulaciones inyectables de paliperidona de liberación prolongada.
AU2022337993A1 (en) 2021-08-30 2024-04-11 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013509435A (ja) 2009-10-30 2013-03-14 ヤンセン ファーマシューティカ エヌ．ベー． 長時間作用型注入可能パリペリドンエステルに関連した投与レジメン
JP2018510894A (ja) 2015-04-07 2018-04-19 ヤンセン ファーマシューティカルズ，インコーポレーテッド 長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン
JP2018520382A (ja) 2015-06-19 2018-07-26 ヤンセン ファーマシューティカ エヌ．ベー． 薬物の投与及び混合のための装置及び方法、並びにそのための適切な技法のトレーニング

Non-Patent Citations (2)

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Title
"A Study of Paliperidone Palmitate 6-MonthFormulation",［online］，2020年06月16日，[令和7年5月28日検索], インターネット, ＜URL：https://clinicaltrials.gov/study/NCT03345342?tab=history&a=34#version-content-panel＞
Health and Quality of Life Outcomes，2012年，Vol.10, No.35，pp.1-9

Also Published As

Publication number Publication date
TWI838623B (zh) 2024-04-11
RS65133B1 (sr) 2024-02-29
TW202440122A (zh) 2024-10-16
FI4025187T3 (fi) 2024-02-13
DK4025187T3 (da) 2024-03-04
SI4025187T1 (sl) 2024-03-29
US20220168306A1 (en) 2022-06-02
US11324751B1 (en) 2022-05-10
CA3203448A1 (en) 2022-06-02
TW202222318A (zh) 2022-06-16
AU2024202306A1 (en) 2024-05-02
SMT202400075T1 (it) 2024-03-13
ES2974822T3 (es) 2024-07-01
IL303251A (en) 2023-07-01
MX2024013364A (es) 2024-12-06
HRP20240086T1 (hr) 2024-03-29
PT4025187T (pt) 2024-02-28
AU2026201895A1 (en) 2026-04-02
EP4025187A1 (en) 2022-07-13
MX2023006370A (es) 2023-08-07
KR20230116837A (ko) 2023-08-04
AU2021387679A1 (en) 2023-07-20
PL4025187T3 (pl) 2024-04-29
HUE065387T2 (hu) 2024-05-28
LT4025187T (lt) 2024-02-12
JP2026027249A (ja) 2026-02-18
TWI897289B (zh) 2025-09-11
AU2024202306B2 (en) 2026-01-15
CN116507320A (zh) 2023-07-28
ZA202400851B (en) 2025-04-30
EP4385564A2 (en) 2024-06-19
US12208100B2 (en) 2025-01-28
EP4385564A3 (en) 2024-10-09
EP4025187B1 (en) 2024-01-03
US20230105276A1 (en) 2023-04-06
WO2022111858A1 (en) 2022-06-02
JP2023552149A (ja) 2023-12-14
MA71365A (fr) 2025-04-30
AU2021387679B2 (en) 2024-01-18

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