JP7503632B2 - 液体タシメルテオン製剤及びそれを使用する方法 - Google Patents

液体タシメルテオン製剤及びそれを使用する方法 Download PDF

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Publication number
JP7503632B2
JP7503632B2 JP2022535961A JP2022535961A JP7503632B2 JP 7503632 B2 JP7503632 B2 JP 7503632B2 JP 2022535961 A JP2022535961 A JP 2022535961A JP 2022535961 A JP2022535961 A JP 2022535961A JP 7503632 B2 JP7503632 B2 JP 7503632B2
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Japan
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tasimelteon
composition
concentration
suspension
less
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Japanese (ja)
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JP2023506225A5 (enExample
JP2023506225A (ja
Inventor
パドケ、ディーパック
ポリメロプロス、ミハエル
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Vanda Pharmaceuticals Inc
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Vanda Pharmaceuticals Inc
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Publication of JP2023506225A publication Critical patent/JP2023506225A/ja
Publication of JP2023506225A5 publication Critical patent/JP2023506225A5/ja
Priority to JP2024064780A priority Critical patent/JP7875899B2/ja
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    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • 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
    • A61K9/08—Solutions
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)
JP2022535961A 2019-12-13 2020-12-11 液体タシメルテオン製剤及びそれを使用する方法 Active JP7503632B2 (ja)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2024064780A JP7875899B2 (ja) 2019-12-13 2024-04-12 液体タシメルテオン製剤及びそれを使用する方法
JP2026061286A JP2026117039A (ja) 2019-12-13 2026-04-02 液体タシメルテオン製剤及びそれを使用する方法

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201962947774P 2019-12-13 2019-12-13
US62/947,774 2019-12-13
US202062972902P 2020-02-11 2020-02-11
US62/972,902 2020-02-11
US202063119488P 2020-11-30 2020-11-30
US63/119,488 2020-11-30
PCT/US2020/064555 WO2021119456A1 (en) 2019-12-13 2020-12-11 Liquid tasimelteon formulations and methods of use thereof

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2024064780A Division JP7875899B2 (ja) 2019-12-13 2024-04-12 液体タシメルテオン製剤及びそれを使用する方法

Publications (3)

Publication Number Publication Date
JP2023506225A JP2023506225A (ja) 2023-02-15
JP2023506225A5 JP2023506225A5 (enExample) 2023-12-20
JP7503632B2 true JP7503632B2 (ja) 2024-06-20

Family

ID=73856392

Family Applications (3)

Application Number Title Priority Date Filing Date
JP2022535961A Active JP7503632B2 (ja) 2019-12-13 2020-12-11 液体タシメルテオン製剤及びそれを使用する方法
JP2024064780A Active JP7875899B2 (ja) 2019-12-13 2024-04-12 液体タシメルテオン製剤及びそれを使用する方法
JP2026061286A Pending JP2026117039A (ja) 2019-12-13 2026-04-02 液体タシメルテオン製剤及びそれを使用する方法

Family Applications After (2)

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JP2024064780A Active JP7875899B2 (ja) 2019-12-13 2024-04-12 液体タシメルテオン製剤及びそれを使用する方法
JP2026061286A Pending JP2026117039A (ja) 2019-12-13 2026-04-02 液体タシメルテオン製剤及びそれを使用する方法

Country Status (14)

Country Link
US (5) US11202770B2 (enExample)
EP (1) EP4072542A1 (enExample)
JP (3) JP7503632B2 (enExample)
KR (1) KR102650321B1 (enExample)
CN (1) CN114727978A (enExample)
AU (3) AU2020400065B2 (enExample)
CA (1) CA3161975A1 (enExample)
CL (1) CL2022001546A1 (enExample)
CO (1) CO2022009691A2 (enExample)
IL (2) IL292492A (enExample)
MX (2) MX2022006577A (enExample)
NZ (1) NZ811397A (enExample)
WO (1) WO2021119456A1 (enExample)
ZA (1) ZA202207188B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR101587394B1 (ko) * 2006-05-22 2016-01-21 반다 파마슈티칼즈, 인코퍼레이티드. 멜라토닌 효능제 치료
CN106604726A (zh) * 2014-09-02 2017-04-26 万达制药公司 用于治疗史密斯‑马吉利综合征的他司美琼
NZ811397A (en) * 2019-12-13 2025-11-28 Vanda Pharmaceuticals Inc Liquid tasimelteon formulations and methods of use thereof
AU2022345260A1 (en) 2021-09-14 2024-04-04 Vanda Pharmaceuticals Inc. Treatment of sleep disturbances in autism spectrum disorder patients
WO2024258786A1 (en) 2023-06-12 2024-12-19 Vanda Pharmaceuticals Inc. Tasimelteon for use in the treatment of delayed sleep-wake phase disorder

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001505916A (ja) 1996-12-10 2001-05-08 ブリストル−マイヤーズ スクイブ カンパニー ベンゾジオキソール、ベンゾフラン、ジヒドロベンゾフランおよびベンゾジオキサンメラトニン作用薬
US20120136050A1 (en) 2009-07-16 2012-05-31 Vanda Pharmaceuticals Inc. Use of a melatonin agonist for the treatment of sleep disorders including primary insomnia
JP2017526693A (ja) 2014-09-02 2017-09-14 バンダ・ファーマシューティカルズ・インコーポレイテッドＶａｎｄａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． スミス‐マゲニス症候群を治療するためのタシメルテオン

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050137247A1 (en) * 2003-12-22 2005-06-23 The Brigham And Women's Hospital, Inc. Methods and compositions for treatment of hypertension
KR101587394B1 (ko) 2006-05-22 2016-01-21 반다 파마슈티칼즈, 인코퍼레이티드. 멜라토닌 효능제 치료
US20080260837A1 (en) * 2007-04-20 2008-10-23 Qpharma, L.L.C. Physically stable aqueous suspensions of active pharmaceuticals
WO2011112167A1 (en) * 2009-03-13 2011-09-15 Reset Therapeutics, Inc. Compositions and methods for diabetes treatment
IL330095A (en) 2012-01-26 2026-08-01 Vanda Pharmaceuticals Inc Tesimalta for use in the treatment of asynchronous circadian rhythm of cortisol
CN102675268A (zh) 2012-05-18 2012-09-19 济南志合医药科技有限公司 制备（1r，2r）-2-（2,3-二氢苯并呋喃-4-基）环丙甲胺的方法
IL266159B2 (en) 2012-12-18 2024-07-01 Vanda Pharmaceuticals Inc Treatment of circadian rhythm disorders
US10376487B2 (en) 2013-11-12 2019-08-13 Vanda Pharmaceuticals Inc. Method of treatment
JP6921534B2 (ja) 2014-02-12 2021-08-18 バンダ・ファーマシューティカルズ・インコーポレイテッドＶａｎｄａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． 高純度医薬品等級タシメルテオン
CN106542973B (zh) * 2015-09-16 2019-06-25 南京华威医药科技集团有限公司 他司美琼中间体及其制备方法
WO2017059877A1 (en) 2015-10-07 2017-04-13 Rontis Hellas S.A. Pharmaceutical composition containing agomelatine and process for the preparation thereof
US9944616B2 (en) * 2016-06-08 2018-04-17 Apotex Inc. Processes for the preparation of Tasimelteon and intermediates thereof
NZ811397A (en) * 2019-12-13 2025-11-28 Vanda Pharmaceuticals Inc Liquid tasimelteon formulations and methods of use thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001505916A (ja) 1996-12-10 2001-05-08 ブリストル−マイヤーズ スクイブ カンパニー ベンゾジオキソール、ベンゾフラン、ジヒドロベンゾフランおよびベンゾジオキサンメラトニン作用薬
US20120136050A1 (en) 2009-07-16 2012-05-31 Vanda Pharmaceuticals Inc. Use of a melatonin agonist for the treatment of sleep disorders including primary insomnia
JP2017526693A (ja) 2014-09-02 2017-09-14 バンダ・ファーマシューティカルズ・インコーポレイテッドＶａｎｄａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｃ． スミス‐マゲニス症候群を治療するためのタシメルテオン

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
医薬品添加物事典 ２００７，株式会社薬事日報社，2007年07月25日，第１６６頁，第２２６頁，第２８６頁

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Publication number Publication date
US12447141B2 (en) 2025-10-21
JP2024084859A (ja) 2024-06-25
US20260007633A1 (en) 2026-01-08
US11759446B2 (en) 2023-09-19
US11202770B2 (en) 2021-12-21
MX2026003536A (es) 2026-05-04
US20210177799A1 (en) 2021-06-17
CL2022001546A1 (es) 2023-02-24
MX2022006577A (es) 2022-07-04
NZ811397A (en) 2025-11-28
US20250090492A1 (en) 2025-03-20
AU2026202446A1 (en) 2026-04-23
CN114727978A (zh) 2022-07-08
JP2026117039A (ja) 2026-07-14
JP7875899B2 (ja) 2026-06-18
AU2025205489B2 (en) 2026-01-29
KR102650321B1 (ko) 2024-03-21
CO2022009691A2 (es) 2022-07-29
US12440470B2 (en) 2025-10-14
WO2021119456A1 (en) 2021-06-17
AU2025205489A1 (en) 2025-08-14
AU2020400065B2 (en) 2025-08-14
EP4072542A1 (en) 2022-10-19
JP2023506225A (ja) 2023-02-15
US20210212980A1 (en) 2021-07-15
AU2020400065A1 (en) 2022-06-30
IL292492A (en) 2022-06-01
NZ811345A (en) 2025-07-25
KR20220113983A (ko) 2022-08-17
ZA202207188B (en) 2022-08-31
US20230372285A1 (en) 2023-11-23
IL317244A (en) 2025-01-01
NZ789270A (en) 2024-07-05
CA3161975A1 (en) 2021-06-17

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