IL273300B2 - High dose valbenazine formulation and related preparations, methods and kits - Google Patents

High dose valbenazine formulation and related preparations, methods and kits

Info

Publication number
IL273300B2
IL273300B2 IL273300A IL27330020A IL273300B2 IL 273300 B2 IL273300 B2 IL 273300B2 IL 273300 A IL273300 A IL 273300A IL 27330020 A IL27330020 A IL 27330020A IL 273300 B2 IL273300 B2 IL 273300B2
Authority
IL
Israel
Prior art keywords
pharmaceutical composition
solid pharmaceutical
dosage form
unit dosage
present
Prior art date
Application number
IL273300A
Other languages
English (en)
Hebrew (he)
Other versions
IL273300B1 (en
IL273300A (en
Original Assignee
Neurocrine Biosciences 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=63794661&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL273300(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Neurocrine Biosciences Inc filed Critical Neurocrine Biosciences Inc
Publication of IL273300A publication Critical patent/IL273300A/en
Publication of IL273300B1 publication Critical patent/IL273300B1/en
Publication of IL273300B2 publication Critical patent/IL273300B2/en

Links

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
    • A61K31/435—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
    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
    • 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
    • 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
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/36—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
    • A61K9/0012—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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system

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)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Physiology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Nutrition Science (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
IL273300A 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits IL273300B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762561629P 2017-09-21 2017-09-21
US201762564951P 2017-09-28 2017-09-28
PCT/US2018/051579 WO2019060322A2 (en) 2017-09-21 2018-09-18 HIGH DOSAGE VALBENAZINE FORMULATION AND COMPOSITIONS, METHODS AND KITS THEREOF

Publications (3)

Publication Number Publication Date
IL273300A IL273300A (en) 2020-04-30
IL273300B1 IL273300B1 (en) 2024-02-01
IL273300B2 true IL273300B2 (en) 2024-06-01

Family

ID=63794661

Family Applications (3)

Application Number Title Priority Date Filing Date
IL273300A IL273300B2 (en) 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits
IL309802A IL309802A (en) 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits
IL301770A IL301770B2 (en) 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits

Family Applications After (2)

Application Number Title Priority Date Filing Date
IL309802A IL309802A (en) 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits
IL301770A IL301770B2 (en) 2017-09-21 2018-09-18 High dose valbenazine formulation and related preparations, methods and kits

Country Status (24)

Country Link
US (3) US20200276184A1 (enExample)
EP (1) EP3684333B1 (enExample)
JP (1) JP7250006B2 (enExample)
CN (1) CN111372567B (enExample)
AU (1) AU2018335259B2 (enExample)
BR (1) BR112020005373A2 (enExample)
CA (1) CA3076000A1 (enExample)
DK (1) DK3684333T3 (enExample)
ES (1) ES3024958T3 (enExample)
FI (1) FI3684333T3 (enExample)
HR (1) HRP20250561T1 (enExample)
HU (1) HUE071873T2 (enExample)
IL (3) IL273300B2 (enExample)
LT (1) LT3684333T (enExample)
MA (1) MA50175B1 (enExample)
MD (1) MD3684333T2 (enExample)
MX (1) MX2020002841A (enExample)
PL (1) PL3684333T3 (enExample)
PT (1) PT3684333T (enExample)
RS (1) RS66714B1 (enExample)
SI (1) SI3684333T1 (enExample)
SM (1) SMT202500305T1 (enExample)
TW (1) TWI875681B (enExample)
WO (1) WO2019060322A2 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10065952B2 (en) 2015-10-30 2018-09-04 Neurocrine Biosciences, Inc. Valbenazine salts and polymorphs thereof
CN108925135B (zh) 2015-12-23 2025-09-19 纽罗克里生物科学有限公司 制备(S)-(2R,3R,11bR)-3-异丁基-9,10-二甲氧基-2,3,4,6,7,11b-六氢-1H-吡啶并[2,1-a]异喹啉-2-基2-氨基-3-甲基丁酸酯二(4-甲基苯磺酸盐)的合成方法
EA202090676A1 (ru) 2017-01-27 2021-10-08 Нейрокрин Байосайенсиз, Инк. Способы введения некоторых vmat2-ингибиторов
IL273300B2 (en) 2017-09-21 2024-06-01 Neurocrine Biosciences Inc High dose valbenazine formulation and related preparations, methods and kits
KR20200066661A (ko) 2017-10-10 2020-06-10 뉴로크린 바이오사이언시즈 인코퍼레이티드 특정 vmat2 억제제의 투여 방법
KR20250070134A (ko) 2017-10-10 2025-05-20 뉴로크린 바이오사이언시즈 인코퍼레이티드 특정 vmat2 억제제의 투여 방법
CA3086611C (en) 2017-12-26 2023-07-25 Crystal Pharmaceutical (Suzhou) Co., Ltd. A crystalline form of valbenazine ditosylate, processes for preparation thereof and use thereof
TW202011963A (zh) 2018-06-14 2020-04-01 美商紐羅克里生物科學有限公司 Vmat2抑制劑化合物、組合物及其相關方法
KR20210044817A (ko) 2018-08-15 2021-04-23 뉴로크린 바이오사이언시즈 인코퍼레이티드 특정 vmat2 억제제의 투여 방법
US10940141B1 (en) * 2019-08-23 2021-03-09 Neurocrine Biosciences, Inc. Methods for the administration of certain VMAT2 inhibitors
US20220363680A1 (en) 2019-09-13 2022-11-17 Neurocrine Biosciences, Inc. Processes for the synthesis of valbenazine
JP2024516199A (ja) 2021-04-26 2024-04-12 ニューロクライン バイオサイエンシーズ，インコーポレイテッド バルベナジンの合成方法
WO2025038959A1 (en) 2023-08-17 2025-02-20 Neurocrine Biosciences, Inc. Methods for the administration of certain vmat2 inhibitors
WO2025038938A1 (en) 2023-08-17 2025-02-20 Neurocrine Biosciences, Inc. Valbenazine for use in the treatment of huntington's chorea

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016210180A2 (en) * 2015-06-23 2016-12-29 Neurocrine Biosciences, Inc. Vmat2 inhibitors for treating neurological diseases or disorders

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