ES2973583T3 - Regímenes de administración asociados a las formulaciones inyectables de paliperidona de liberación prolongada - Google Patents

Regímenes de administración asociados a las formulaciones inyectables de paliperidona de liberación prolongada Download PDF

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Publication number
ES2973583T3
ES2973583T3 ES21724652T ES21724652T ES2973583T3 ES 2973583 T3 ES2973583 T3 ES 2973583T3 ES 21724652 T ES21724652 T ES 21724652T ES 21724652 T ES21724652 T ES 21724652T ES 2973583 T3 ES2973583 T3 ES 2973583T3
Authority
ES
Spain
Prior art keywords
paliperidone palmitate
suspension
dose
approximately
paliperidone
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
ES21724652T
Other languages
English (en)
Spanish (es)
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=75888043&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2973583(T3) "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
Application granted granted Critical
Publication of ES2973583T3 publication Critical patent/ES2973583T3/es
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
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (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)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Psychiatry (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (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)
ES21724652T 2020-11-30 2021-05-07 Regímenes de administración asociados a las formulaciones inyectables de paliperidona de liberación prolongada Active ES2973583T3 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063119405P 2020-11-30 2020-11-30
PCT/EP2021/062147 WO2022111859A1 (en) 2020-11-30 2021-05-07 Dosing regimens associated with extended release paliperidone injectable formulations

Publications (1)

Publication Number Publication Date
ES2973583T3 true ES2973583T3 (es) 2024-06-20

Family

ID=75888043

Family Applications (1)

Application Number Title Priority Date Filing Date
ES21724652T Active ES2973583T3 (es) 2020-11-30 2021-05-07 Regímenes de administración asociados a las formulaciones inyectables de paliperidona de liberación prolongada

Country Status (22)

Country Link
US (3) US11304951B1 (https=)
EP (2) EP4025188B1 (https=)
JP (2) JP7792959B2 (https=)
KR (2) KR102794804B1 (https=)
CN (1) CN116583270A (https=)
AU (2) AU2021386450B2 (https=)
CA (1) CA3203566A1 (https=)
DK (1) DK4025188T3 (https=)
ES (1) ES2973583T3 (https=)
FI (1) FI4025188T3 (https=)
HR (1) HRP20240074T1 (https=)
HU (1) HUE065573T2 (https=)
IL (1) IL303253A (https=)
LT (1) LT4025188T (https=)
MX (2) MX2023006366A (https=)
PL (1) PL4025188T3 (https=)
PT (1) PT4025188T (https=)
RS (1) RS65178B1 (https=)
SI (1) SI4025188T1 (https=)
SM (1) SMT202400077T1 (https=)
TW (2) TWI877363B (https=)
WO (1) WO2022111859A1 (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
KR102794804B1 (ko) * 2020-11-30 2025-04-10 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법
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.

Family Cites Families (14)

* 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
WO2016157061A1 (en) * 2015-03-31 2016-10-06 Wockhardt Limited Aseptic wet milling process for paliperidone palmitate
RS65024B1 (sr) * 2015-04-07 2024-01-31 Janssen Pharmaceutica Nv Dozni režim za propuštene doze injektibilnih estara paliperidona sa produženim delovanjem
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
PL3723760T3 (pl) * 2017-12-14 2025-10-20 SpecGx LLC Jednoetapowy sposób mielenia w celu wytworzenia zmikronizowanych estrów paliperydonu
KR102794804B1 (ko) * 2020-11-30 2025-04-10 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법

Also Published As

Publication number Publication date
SMT202400077T1 (it) 2024-03-13
WO2022111859A1 (en) 2022-06-02
AU2021386450A1 (en) 2023-07-13
SI4025188T1 (sl) 2024-03-29
AU2024204213B2 (en) 2026-02-26
US11304951B1 (en) 2022-04-19
US20260060986A1 (en) 2026-03-05
EP4025188A1 (en) 2022-07-13
JP2026027255A (ja) 2026-02-18
JP7792959B2 (ja) 2025-12-26
JP2023552329A (ja) 2023-12-15
KR20250053980A (ko) 2025-04-22
US20220249495A1 (en) 2022-08-11
TWI877363B (zh) 2025-03-21
KR102794804B1 (ko) 2025-04-10
MX2024009188A (es) 2024-08-06
PT4025188T (pt) 2024-02-29
AU2024204213A1 (en) 2024-07-11
HUE065573T2 (hu) 2024-06-28
RS65178B1 (sr) 2024-03-29
CA3203566A1 (en) 2022-06-02
LT4025188T (lt) 2024-03-12
TW202222319A (zh) 2022-06-16
AU2021386450B2 (en) 2024-03-21
EP4356966A3 (en) 2024-07-17
DK4025188T3 (da) 2024-03-04
HRP20240074T1 (hr) 2024-03-29
CN116583270A (zh) 2023-08-11
IL303253A (en) 2023-07-01
PL4025188T3 (pl) 2024-06-17
EP4356966A2 (en) 2024-04-24
TW202539685A (zh) 2025-10-16
FI4025188T3 (fi) 2024-02-21
AU2021386450A9 (en) 2025-03-13
EP4025188B1 (en) 2024-01-10
MX2023006366A (es) 2023-08-07
KR20230116013A (ko) 2023-08-03

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