BR112017021383A2 - regime de dosagem para doses omitidas de ésteres de paliperidona injetáveis de longa ação - Google Patents

regime de dosagem para doses omitidas de ésteres de paliperidona injetáveis de longa ação

Info

Publication number
BR112017021383A2
BR112017021383A2 BR112017021383-4A BR112017021383A BR112017021383A2 BR 112017021383 A2 BR112017021383 A2 BR 112017021383A2 BR 112017021383 A BR112017021383 A BR 112017021383A BR 112017021383 A2 BR112017021383 A2 BR 112017021383A2
Authority
BR
Brazil
Prior art keywords
long
dosing regimen
acting injectable
missed doses
injectable paliperidone
Prior art date
Application number
BR112017021383-4A
Other languages
English (en)
Inventor
Gopal Srihari
Gerarda Maria Ravenstijn Paulien
Russu Alberto
Narain Samtani Mahesh
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
Family has litigation
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=BR112017021383(A2) "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.
Publication of BR112017021383A2 publication Critical patent/BR112017021383A2/pt

Links

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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Dermatology (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Psychiatry (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

o presente pedido fornece um método para o tratamento de pacientes que necessitam de tratamento psiquiátrico, sendo que o dito paciente está sendo tratado com a formulação trimestral de palmitato de paliperidona e esquece de tomar a próxima dose programada da formulação trimestral de palmitato de paliperidona.
BR112017021383-4A 2015-04-07 2016-03-30 regime de dosagem para doses omitidas de ésteres de paliperidona injetáveis de longa ação BR112017021383A2 (pt)

Applications Claiming Priority (5)

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
PCT/US2016/024841 WO2016164218A1 (en) 2015-04-07 2016-03-30 Dosing regimen for missed doses for long-acting injectable paliperidone esters

Publications (1)

Publication Number Publication Date
BR112017021383A2 true BR112017021383A2 (pt) 2018-07-03

Family

ID=57072843

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017021383-4A BR112017021383A2 (pt) 2015-04-07 2016-03-30 regime de dosagem para doses omitidas de ésteres de paliperidona injetáveis de longa ação

Country Status (27)

Country Link
US (1) US10143693B2 (pt)
EP (3) EP4349323A2 (pt)
JP (3) JP6728221B2 (pt)
KR (2) KR102606678B1 (pt)
AU (3) AU2016244801B2 (pt)
BR (1) BR112017021383A2 (pt)
CA (2) CA3088401A1 (pt)
CY (1) CY1123203T1 (pt)
DK (2) DK3280416T3 (pt)
EA (1) EA037185B1 (pt)
ES (2) ES2802299T3 (pt)
FI (1) FI3744326T3 (pt)
HK (1) HK1249047A1 (pt)
HR (2) HRP20240022T1 (pt)
HU (1) HUE049485T2 (pt)
IL (2) IL254669B2 (pt)
LT (2) LT3744326T (pt)
MA (1) MA41917B1 (pt)
MD (1) MD3280416T2 (pt)
NZ (1) NZ735952A (pt)
PL (2) PL3744326T3 (pt)
PT (2) PT3744326T (pt)
RS (2) RS65024B1 (pt)
SI (2) SI3280416T1 (pt)
TW (1) TWI694825B (pt)
UA (1) UA118732C2 (pt)
WO (1) WO2016164218A1 (pt)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
LT3744326T (lt) 2015-04-07 2023-12-27 Janssen Pharmaceutica Nv Dozavimo schema praleistoms ilgai veikiančių injekcinių paliperidono esterių dozėms
CA3077224A1 (en) 2017-10-27 2019-05-02 Shandong Luye Pharmaceutical Co., Ltd. Dosage regimen of paliperidone palmitate extended-release injectable suspension
KR20230116836A (ko) 2020-11-30 2023-08-04 얀센 파마슈티카 엔.브이. 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법
CN116528837A (zh) * 2020-11-30 2023-08-01 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
WO2022111859A1 (en) 2020-11-30 2022-06-02 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
FI4025187T3 (fi) * 2020-11-30 2024-02-13 Janssen Pharmaceutica Nv Pitkävaikutteisiin injektoitaviin paliperidoniformulaatioihin liittyviä annosteluohjelmia
JP2023551007A (ja) 2020-11-30 2023-12-06 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
WO2023021008A1 (en) 2021-08-20 2023-02-23 Janssen Pharmaceutica Nv Dosing regimens associated with extended release paliperidone injectable formulations
KR20240052810A (ko) * 2021-08-30 2024-04-23 얀센 파마슈티카 엔브이 서방형 팔리페리돈 주사용 제형과 관련된 투약 요법

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
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
CN105560176A (zh) * 2007-12-19 2016-05-11 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
US8758780B2 (en) * 2009-10-06 2014-06-24 Ascendis Pharma As Subcutaneous paliperidone composition
NZ599558A (en) 2009-10-30 2014-09-26 Janssen Pharmaceutica Nv Dosing regimen associated with long-acting injectable paliperidone esters
PT2529757E (pt) * 2011-05-31 2014-02-27 Rovi Lab Farmaceut Sa Formulação para implante de paliperidona
LT3744326T (lt) 2015-04-07 2023-12-27 Janssen Pharmaceutica Nv Dozavimo schema praleistoms ilgai veikiančių injekcinių paliperidono esterių dozėms

Also Published As

Publication number Publication date
EP3744326B1 (en) 2023-12-06
AU2016244801A1 (en) 2017-10-05
HUE049485T2 (hu) 2020-09-28
ES2802299T3 (es) 2021-01-18
PT3280416T (pt) 2020-06-30
KR102606678B1 (ko) 2023-11-24
IL254669A0 (en) 2017-11-30
RS65024B1 (sr) 2024-01-31
AU2020239611B2 (en) 2022-07-21
EA037185B1 (ru) 2021-02-17
JP7422277B2 (ja) 2024-01-26
US20170281629A1 (en) 2017-10-05
MA41917B1 (fr) 2020-07-29
NZ735952A (en) 2022-02-25
EP3280416A1 (en) 2018-02-14
JP2018510894A (ja) 2018-04-19
HRP20201027T1 (hr) 2020-12-11
PT3744326T (pt) 2024-01-15
WO2016164218A1 (en) 2016-10-13
US10143693B2 (en) 2018-12-04
EA201792209A1 (ru) 2018-02-28
UA118732C2 (uk) 2019-02-25
JP7228503B2 (ja) 2023-02-24
JP2020090498A (ja) 2020-06-11
CY1123203T1 (el) 2021-10-29
LT3280416T (lt) 2020-06-25
CA3088401A1 (en) 2016-10-07
EP4349323A2 (en) 2024-04-10
LT3744326T (lt) 2023-12-27
HK1249047A1 (zh) 2018-10-26
FI3744326T3 (fi) 2024-02-02
KR20170134583A (ko) 2017-12-06
KR20230162162A (ko) 2023-11-28
RS60510B1 (sr) 2020-08-31
HRP20240022T1 (hr) 2024-03-29
CA2925908A1 (en) 2016-10-07
SI3744326T1 (sl) 2024-02-29
JP2021130680A (ja) 2021-09-09
PL3280416T3 (pl) 2020-12-14
MD3280416T2 (ro) 2020-10-31
CA2925908C (en) 2020-09-01
IL309340A (en) 2024-02-01
DK3744326T3 (da) 2024-02-05
EP3280416A4 (en) 2019-01-23
SI3280416T1 (sl) 2020-07-31
TW201642863A (zh) 2016-12-16
EP3744326A1 (en) 2020-12-02
PL3744326T3 (pl) 2024-03-25
DK3280416T3 (da) 2020-05-11
IL254669B1 (en) 2024-01-01
IL254669B2 (en) 2024-05-01
EP3280416B1 (en) 2020-04-22
ES2967585T3 (es) 2024-05-03
AU2016244801B2 (en) 2020-06-25
AU2020239611A1 (en) 2020-10-15
TWI694825B (zh) 2020-06-01
JP6728221B2 (ja) 2020-07-22
AU2022221405A1 (en) 2022-09-15

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Legal Events

Date Code Title Description
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09B Patent application refused [chapter 9.2 patent gazette]