CA2778301C - Compositions comprising palonosetron and netupitant for treating nausea and vomiting - Google Patents

Compositions comprising palonosetron and netupitant for treating nausea and vomiting Download PDF

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Publication number
CA2778301C
CA2778301C CA2778301A CA2778301A CA2778301C CA 2778301 C CA2778301 C CA 2778301C CA 2778301 A CA2778301 A CA 2778301A CA 2778301 A CA2778301 A CA 2778301A CA 2778301 C CA2778301 C CA 2778301C
Authority
CA
Canada
Prior art keywords
netupitant
palonosetron
pharmaceutically acceptable
acceptable salt
vomiting
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
CA2778301A
Other languages
English (en)
French (fr)
Other versions
CA2778301A1 (en
Inventor
Fabio Trento
Sergio Cantoreggi
Giorgia Rossi
Roberta Cannella
Daniele Bonadeo
Riccardo Braglia
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.)
Helsinn Healthcare SA
Original Assignee
Helsinn Healthcare SA
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=43608757&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2778301(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Helsinn Healthcare SA filed Critical Helsinn Healthcare SA
Publication of CA2778301A1 publication Critical patent/CA2778301A1/en
Application granted granted Critical
Publication of CA2778301C publication Critical patent/CA2778301C/en
Active legal-status Critical Current
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • 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
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
    • A61K31/4178—1,3-Diazoles not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin
    • 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
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
    • 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
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
    • 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
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4858—Organic compounds
    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4841—Filling excipients; Inactive ingredients
    • A61K9/4866—Organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/38—Drugs for disorders of the endocrine system of the suprarenal hormones
    • A61P5/44—Glucocorticosteroids; Drugs increasing or potentiating the activity of glucocorticosteroids

Landscapes

  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Endocrinology (AREA)
  • Diabetes (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Plant Substances (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Paints Or Removers (AREA)
CA2778301A 2009-11-18 2010-11-18 Compositions comprising palonosetron and netupitant for treating nausea and vomiting Active CA2778301C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US26247009P 2009-11-18 2009-11-18
US61/262,470 2009-11-18
US38270910P 2010-09-14 2010-09-14
US61/382,709 2010-09-14
PCT/IB2010/003106 WO2011061622A1 (en) 2009-11-18 2010-11-18 Compositions for treating centrally mediated nausea and vomiting

Publications (2)

Publication Number Publication Date
CA2778301A1 CA2778301A1 (en) 2011-05-26
CA2778301C true CA2778301C (en) 2016-06-14

Family

ID=43608757

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2778301A Active CA2778301C (en) 2009-11-18 2010-11-18 Compositions comprising palonosetron and netupitant for treating nausea and vomiting

Country Status (40)

Country Link
US (1) US12042494B2 (OSRAM)
EP (3) EP2727590B1 (OSRAM)
JP (1) JP5890780B2 (OSRAM)
KR (1) KR101615108B1 (OSRAM)
CN (6) CN107050455B (OSRAM)
AP (1) AP3083A (OSRAM)
AU (1) AU2010320598B2 (OSRAM)
BR (1) BR112012011485B1 (OSRAM)
CA (1) CA2778301C (OSRAM)
CL (1) CL2012001276A1 (OSRAM)
CO (1) CO6551693A2 (OSRAM)
CR (1) CR20120216A (OSRAM)
CU (1) CU24048B1 (OSRAM)
CY (1) CY1118062T1 (OSRAM)
DK (2) DK2361090T3 (OSRAM)
DO (1) DOP2012000138A (OSRAM)
EA (1) EA026815B1 (OSRAM)
EC (1) ECSP12011907A (OSRAM)
ES (4) ES2559475T3 (OSRAM)
GE (1) GEP20156226B (OSRAM)
GT (1) GT201200156A (OSRAM)
HK (2) HK1214147A1 (OSRAM)
HR (3) HRP20140759T1 (OSRAM)
HU (1) HUE029677T2 (OSRAM)
IL (1) IL219576A (OSRAM)
LT (1) LT2722045T (OSRAM)
MA (1) MA33810B1 (OSRAM)
MX (1) MX2012005347A (OSRAM)
MY (1) MY159393A (OSRAM)
NI (1) NI201200090A (OSRAM)
NZ (1) NZ599439A (OSRAM)
PE (1) PE20121483A1 (OSRAM)
PH (1) PH12012500887A1 (OSRAM)
PL (3) PL2722045T3 (OSRAM)
PT (2) PT2361090E (OSRAM)
RS (2) RS53491B1 (OSRAM)
SI (2) SI2361090T1 (OSRAM)
SM (1) SMT201400112B (OSRAM)
TN (1) TN2012000170A1 (OSRAM)
WO (1) WO2011061622A1 (OSRAM)

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EP2722045B1 (en) 2009-11-18 2016-07-06 Helsinn Healthcare SA Compositions for treating centrally mediated nausea and vomiting
LT2722045T (lt) 2009-11-18 2016-09-26 Helsinn Healthcare Sa Kompozicija skirta gydyti centralizuotai kontroliuojamą pykinimą ir vėmimą
WO2013004766A1 (en) * 2011-07-04 2013-01-10 Ferrari Giulio Nk-1 receptor antagonists for treating corneal neovascularisation
JP2014530249A (ja) * 2011-10-18 2014-11-17 ヘルシン ヘルスケア ソシエテ アノニム ネツピタントおよびパロノセトロンの治療学的組合せ
US8426450B1 (en) * 2011-11-29 2013-04-23 Helsinn Healthcare Sa Substituted 4-phenyl pyridines having anti-emetic effect
US9403772B2 (en) 2011-11-29 2016-08-02 Helsinn Healthcare Sa 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator
CN103520725B (zh) * 2012-07-05 2017-10-24 海思科医药集团股份有限公司 一种治疗呕吐的药物组合物
CA3213864A1 (en) 2015-03-04 2016-09-09 Vanda Pharmaceuticals Inc. Dosing regimen of tradipitant
CN106902086B (zh) * 2015-12-23 2020-10-20 江苏恒瑞医药股份有限公司 一种包含奈妥匹坦的固体组合物
GB201618425D0 (en) * 2016-11-01 2016-12-14 Acacia Pharma Ltd method
GB201702250D0 (en) 2017-02-10 2017-03-29 Acacia Pharma Ltd Method
CN108721214B (zh) * 2017-04-14 2020-06-16 和龙 奈妥吡坦和帕洛诺司琼复方纳米粒溶液、纳米粒及制备方法和用途
CN108853010A (zh) * 2017-05-15 2018-11-23 和龙 奈妥吡坦环糊精包合物、复方组合制剂及其制备方法和用途
CN109200018A (zh) * 2017-07-04 2019-01-15 南京诺瑞特医药科技有限公司 含有奈妥吡坦的微乳制剂
FI3710000T3 (fi) * 2017-11-17 2025-07-03 Vanda Pharmaceuticals Inc Tradipitantti käytettäväksi gastropareesin hoidossa
JP2021512869A (ja) * 2018-02-02 2021-05-20 ユーストラリス ファーマシューティカルズ リミテッド （トレーディング アズ プレススラ ニューロ） 経口製剤及びその使用
MX2023007578A (es) * 2020-12-25 2023-07-06 Shanghai Shengdi Pharmaceutical Co Ltd Uso del compuesto profarmaco antagonista nk1 en combinacion con un antagonista del receptor 5-ht3.
EP4385497A1 (en) 2022-12-12 2024-06-19 Alfred E. Tiefenbacher (GmbH & Co. KG) Antioxidant-free fixed dose combination of netupitant and palonosetron
IL321446A (en) 2022-12-12 2025-08-01 Tiefenbacher Alfred E Gmbh & Co Kg Fixed-dose combination including netopitant and flunosterone
EP4385500A1 (en) 2022-12-12 2024-06-19 Alfred E. Tiefenbacher (GmbH & Co. KG) Fixed dose combination comprising netupitant and palonosetron
EP4633608A1 (en) 2022-12-12 2025-10-22 Alfred E. Tiefenbacher (GmbH & Co. KG) Antioxidant-free fixed dose combination of netupitant and palonosetron

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Also Published As

Publication number Publication date
LT2722045T (lt) 2016-09-26
HRP20161277T1 (hr) 2016-11-18
CL2012001276A1 (es) 2012-12-07
HK1214147A1 (zh) 2016-07-22
NZ599439A (en) 2014-06-27
SMT201400112B (it) 2014-11-10
SI2722045T1 (sl) 2017-02-28
PH12012500887A1 (en) 2016-08-26
JP2013511507A (ja) 2013-04-04
TN2012000170A1 (en) 2013-12-12
BR112012011485A2 (pt) 2018-04-03
CY1118062T1 (el) 2017-06-28
EP2361090A1 (en) 2011-08-31
EP2722044A1 (en) 2014-04-23
EP2722044B1 (en) 2017-01-04
GT201200156A (es) 2014-03-27
HUE029677T2 (hu) 2017-03-28
EP2727590A1 (en) 2014-05-07
DOP2012000138A (es) 2012-11-15
GEP20156226B (en) 2015-01-26
PL2722044T3 (pl) 2017-08-31
ES2559475T3 (es) 2016-02-12
CN106421793B (zh) 2023-06-16
CN107050455B (zh) 2020-09-29
SI2361090T1 (sl) 2014-09-30
AU2010320598A1 (en) 2012-06-14
CA2778301A1 (en) 2011-05-26
IL219576A0 (en) 2012-06-28
PL2722045T3 (pl) 2017-03-31
HRP20140759T1 (hr) 2014-10-24
EP2361090B1 (en) 2014-05-21
CN107050455A (zh) 2017-08-18
HK1214148A1 (zh) 2016-07-22
US20230263799A1 (en) 2023-08-24
PE20121483A1 (es) 2012-12-02
CN104856999A (zh) 2015-08-26
WO2011061622A1 (en) 2011-05-26
BR112012011485B1 (pt) 2021-06-29
ECSP12011907A (es) 2012-10-30
IL219576A (en) 2017-08-31
RS55206B1 (sr) 2017-01-31
DK2722045T3 (en) 2016-10-24
MA33810B1 (fr) 2012-12-03
HRP20170419T1 (hr) 2017-06-02
ES2494015T3 (es) 2014-09-12
AP3083A (en) 2015-01-31
CN104856998A (zh) 2015-08-26
KR20120101456A (ko) 2012-09-13
EA201290356A1 (ru) 2012-12-28
ES2595077T3 (es) 2016-12-27
CN106421793A (zh) 2017-02-22
JP5890780B2 (ja) 2016-03-22
RS53491B1 (sr) 2015-02-27
CR20120216A (es) 2012-07-24
US12042494B2 (en) 2024-07-23
NI201200090A (es) 2012-11-13
CN106512010A (zh) 2017-03-22
CU20120078A7 (es) 2012-10-15
CO6551693A2 (es) 2012-10-31
PT2361090E (pt) 2014-09-03
EP2727590B1 (en) 2015-10-21
KR101615108B1 (ko) 2016-05-12
PL2361090T3 (pl) 2014-10-31
AP2012006278A0 (en) 2012-06-30
AU2010320598B2 (en) 2016-06-16
CN102655864A (zh) 2012-09-05
CU24048B1 (es) 2014-12-26
DK2361090T3 (da) 2014-08-25
MY159393A (en) 2016-12-30
PT2722045T (pt) 2016-10-18
EA026815B1 (ru) 2017-05-31
ES2623503T3 (es) 2017-07-11
MX2012005347A (es) 2012-08-03

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