AU2018366212B2 - Fulvestrant formulations and methods of their use - Google Patents

Fulvestrant formulations and methods of their use Download PDF

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Publication number
AU2018366212B2
AU2018366212B2 AU2018366212A AU2018366212A AU2018366212B2 AU 2018366212 B2 AU2018366212 B2 AU 2018366212B2 AU 2018366212 A AU2018366212 A AU 2018366212A AU 2018366212 A AU2018366212 A AU 2018366212A AU 2018366212 B2 AU2018366212 B2 AU 2018366212B2
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AU
Australia
Prior art keywords
days
dose
fulvestrant
microns
weeks
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
AU2018366212A
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English (en)
Other versions
AU2018366212A1 (en
Inventor
Feng-Jing Chen
Adrian HEPNER
Tara JASKOWSKI
Michael Joyce
Steven L. Krill
Rama Abu Shmeis
Charles WESCOTT
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.)
Eagle Pharmaceuticals Inc
Original Assignee
Eagle 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=64650494&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2018366212(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Eagle Pharmaceuticals Inc filed Critical Eagle Pharmaceuticals Inc
Publication of AU2018366212A1 publication Critical patent/AU2018366212A1/en
Application granted granted Critical
Publication of AU2018366212B2 publication Critical patent/AU2018366212B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61K31/495—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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/566—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol having an oxo group in position 17, e.g. estrone
    • 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
    • A61K47/24—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0021—Intradermal administration, e.g. through microneedle arrays or needleless injectors
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

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)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Dispersion Chemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
AU2018366212A 2017-11-08 2018-11-08 Fulvestrant formulations and methods of their use Active AU2018366212B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762583403P 2017-11-08 2017-11-08
US62/583,403 2017-11-08
PCT/US2018/059906 WO2019094650A1 (en) 2017-11-08 2018-11-08 Fulvestrant formulations and methods of their use

Publications (2)

Publication Number Publication Date
AU2018366212A1 AU2018366212A1 (en) 2020-05-14
AU2018366212B2 true AU2018366212B2 (en) 2024-06-20

Family

ID=64650494

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2018366212A Active AU2018366212B2 (en) 2017-11-08 2018-11-08 Fulvestrant formulations and methods of their use

Country Status (15)

Country Link
US (1) US12186427B2 (https=)
EP (1) EP3706719A1 (https=)
JP (1) JP7220712B2 (https=)
KR (1) KR102670293B1 (https=)
CN (1) CN111479556B (https=)
AU (1) AU2018366212B2 (https=)
BR (1) BR112020009141A2 (https=)
CO (1) CO2020006951A2 (https=)
IL (1) IL274433B2 (https=)
MA (1) MA50570A (https=)
MX (2) MX2020004792A (https=)
MY (1) MY204442A (https=)
UA (1) UA128158C2 (https=)
WO (1) WO2019094650A1 (https=)
ZA (1) ZA202002897B (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4074304A4 (en) * 2019-12-11 2024-01-10 Shanghai Bocimed Pharmaceutical Co., Ltd. PHARMACEUTICAL COMPOSITION OF FULVESTRANT, PREPARATION METHOD AND APPLICATION THEREOF
CN120284882A (zh) * 2020-12-10 2025-07-11 上海云晟研新生物科技有限公司 氟维司群药物组合物、其制备方法及应用
JP2024545690A (ja) * 2021-12-20 2024-12-10 サムヤン、ホールディングス、コーポレーション 溶解度が改善されたフルベストラントの医薬組成物及びその製造方法

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0000313D0 (en) 2000-01-10 2000-03-01 Astrazeneca Uk Ltd Formulation
US6495534B2 (en) 2000-05-15 2002-12-17 Pharmacia & Upjohn Spa Stabilized aqueous suspensions for parenteral use
PL367624A1 (en) 2001-07-07 2005-03-07 Astrazeneca Ab Pharmaceutical formulation for the intramuscular administration of fulvestrant
CA2575906C (en) 2004-08-04 2014-04-15 Camurus Ab Compositions forming non-lamellar dispersions
JP2006089386A (ja) * 2004-09-21 2006-04-06 Nippon Tenganyaku Kenkyusho:Kk ステロイドまたはステロイド誘導体を含有する懸濁性医薬組成物
CN1857217A (zh) * 2006-03-28 2006-11-08 济南康泉医药科技有限公司 一种含雌激素受体拮抗剂的抗癌缓释注射剂
CN101244029A (zh) * 2006-03-28 2008-08-20 济南康泉医药科技有限公司 含雌激素受体拮抗剂的抗癌缓释注射剂
JP2011514349A (ja) * 2008-03-07 2011-05-06 サイドース・エルエルシー フルベストラント配合物
CN101525364B (zh) 2008-03-07 2012-12-12 杭州九源基因工程有限公司 一种氟维司群的晶型及其制备方法
WO2011022861A1 (zh) 2009-08-31 2011-03-03 西安力邦医药科技有限责任公司 氟维司群纳米球/微球及其制备方法和用途
WO2011011978A1 (zh) * 2009-07-31 2011-02-03 西安力邦医药科技有限责任公司 微球药物载体、其制备方法、组合物及应用
CN103221052A (zh) 2010-09-16 2013-07-24 施摩达生物技术有限公司 氟维司群组合物及使用方法
EP2711010B1 (en) 2011-05-20 2018-10-31 Capital, Business Y Gestión De Finanzas, S.L Pharmaceutical composition
CA2869377C (en) * 2012-04-09 2022-11-08 Scidose, Llc Fulvestrant formulations
WO2013182668A1 (en) 2012-06-08 2013-12-12 F. Hoffmann-La Roche Ag Mutant selectivity and combinations of a phosphoinositide 3 kinase inhibitor compound and chemotherapeutic agents for the treatment of cancer
CN104782169B (zh) * 2013-07-08 2019-06-28 华为技术有限公司 视频播放的控制方法、设备及系统
CN104337761B (zh) * 2013-08-07 2019-03-26 江苏豪森药业集团有限公司 氟维司群药物组合物
WO2015033302A2 (en) * 2013-09-06 2015-03-12 Salah Uddin Ahmed Fulvestrant compositions
IL285928B2 (en) 2016-05-06 2025-06-01 Eagle Pharmaceuticals Inc Fulvestrant formulations and methods of their use
US11590077B2 (en) * 2016-05-06 2023-02-28 Eagle Pharmaceuticals, Inc. Fulvestrant formulations and methods of their use

Also Published As

Publication number Publication date
MA50570A (fr) 2020-09-16
MY204442A (en) 2024-08-28
RU2020118559A3 (https=) 2021-12-08
IL274433B1 (en) 2024-03-01
KR102670293B1 (ko) 2024-05-30
WO2019094650A1 (en) 2019-05-16
BR112020009141A2 (pt) 2020-10-27
EP3706719A1 (en) 2020-09-16
IL274433A (en) 2020-06-30
KR20200085809A (ko) 2020-07-15
MX2024010323A (es) 2025-02-10
US20230404918A1 (en) 2023-12-21
JP7220712B2 (ja) 2023-02-10
CA3082193A1 (en) 2019-05-16
JP2021502362A (ja) 2021-01-28
MX2020004792A (es) 2020-08-13
RU2020118559A (ru) 2021-12-08
CN111479556A (zh) 2020-07-31
ZA202002897B (en) 2023-10-25
US12186427B2 (en) 2025-01-07
AU2018366212A1 (en) 2020-05-14
CN111479556B (zh) 2023-09-01
CO2020006951A2 (es) 2020-06-19
UA128158C2 (uk) 2024-04-24
IL274433B2 (en) 2024-07-01

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