ES2586122T3 - Formulaciones de testosterona - Google Patents

Formulaciones de testosterona Download PDF

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Publication number
ES2586122T3
ES2586122T3 ES12700406.7T ES12700406T ES2586122T3 ES 2586122 T3 ES2586122 T3 ES 2586122T3 ES 12700406 T ES12700406 T ES 12700406T ES 2586122 T3 ES2586122 T3 ES 2586122T3
Authority
ES
Spain
Prior art keywords
weight
formulation
testosterone
amount
transdermal
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
ES12700406.7T
Other languages
English (en)
Spanish (es)
Inventor
Arnaud Grenier
Dario N. CARRARA
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.)
Ferring BV
Original Assignee
Ferring BV
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=44146428&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2586122(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ferring BV filed Critical Ferring BV
Application granted granted Critical
Publication of ES2586122T3 publication Critical patent/ES2586122T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • 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
    • A61K31/568—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 substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
    • 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
    • A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A61P19/10—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease for osteoporosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00—Drugs for disorders of the muscular or neuromuscular system
    • 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
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/02—Nutrients, e.g. vitamins, minerals
    • 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
    • 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
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/26—Androgens
    • 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
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Dermatology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Inorganic Chemistry (AREA)
  • Neurology (AREA)
  • Dispersion Chemistry (AREA)
  • Rheumatology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Obesity (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Pregnancy & Childbirth (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Nutrition Science (AREA)
  • Neurosurgery (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
ES12700406.7T 2011-01-26 2012-01-18 Formulaciones de testosterona Active ES2586122T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161436207P 2011-01-26 2011-01-26
EP11152210 2011-01-26
US201161436207P 2011-01-26
EP11152210 2011-01-26
PCT/EP2012/050695 WO2012101016A1 (en) 2011-01-26 2012-01-18 Testosterone formulations

Publications (1)

Publication Number Publication Date
ES2586122T3 true ES2586122T3 (es) 2016-10-11

Family

ID=44146428

Family Applications (2)

Application Number Title Priority Date Filing Date
ES12700406.7T Active ES2586122T3 (es) 2011-01-26 2012-01-18 Formulaciones de testosterona
ES16169138T Active ES2741744T3 (es) 2011-01-26 2012-01-18 Formulaciones de testosterona

Family Applications After (1)

Application Number Title Priority Date Filing Date
ES16169138T Active ES2741744T3 (es) 2011-01-26 2012-01-18 Formulaciones de testosterona

Country Status (28)

Country Link
US (2) US8895053B2 (enExample)
EP (2) EP2667851B1 (enExample)
JP (2) JP6012632B2 (enExample)
KR (1) KR101877476B1 (enExample)
CN (1) CN103327962B (enExample)
AR (1) AR085090A1 (enExample)
AU (1) AU2012210691B2 (enExample)
BR (1) BR112013018951B1 (enExample)
CA (1) CA2824941A1 (enExample)
DK (2) DK3072505T3 (enExample)
ES (2) ES2586122T3 (enExample)
HR (2) HRP20160887T1 (enExample)
HU (3) HUE027453T4 (enExample)
IL (1) IL227454A (enExample)
JO (1) JO3755B1 (enExample)
LT (2) LT3072505T (enExample)
MX (1) MX340259B (enExample)
NO (1) NO2018034I1 (enExample)
PL (2) PL3072505T3 (enExample)
PT (2) PT3072505T (enExample)
RS (2) RS59012B1 (enExample)
RU (1) RU2613891C2 (enExample)
SA (1) SA112330224B1 (enExample)
SI (2) SI3072505T1 (enExample)
TR (1) TR201909271T4 (enExample)
TW (1) TWI564029B (enExample)
WO (1) WO2012101016A1 (enExample)
ZA (1) ZA201305665B (enExample)

Families Citing this family (18)

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GB0117057D0 (en) * 2001-07-12 2001-09-05 Ferring Bv Pharmaceutical composition
TWI539959B (zh) 2008-02-11 2016-07-01 菲瑞茵國際中心股份有限公司 治療轉移階段攝護腺癌的方法
US8722088B2 (en) * 2009-05-01 2014-05-13 Ferring International Center S.A. Pharmaceutical compositions and methods for the treatment of prostate cancer
US20110039787A1 (en) * 2009-07-06 2011-02-17 Ferring International Center S.A. Compositions, kits and methods for treating benign prostate hyperplasia
WO2012055903A1 (en) 2010-10-27 2012-05-03 Ferring B.V. Process for the manufacture of degarelix and its intermediates
EP2447276A1 (en) 2010-10-27 2012-05-02 Ferring B.V. Process for the manufacture of Degarelix and its intermediates
US9034858B2 (en) 2010-11-30 2015-05-19 Lipocine Inc. High-strength testosterone undecanoate compositions
US20180153904A1 (en) 2010-11-30 2018-06-07 Lipocine Inc. High-strength testosterone undecanoate compositions
JO3755B1 (ar) 2011-01-26 2021-01-31 Ferring Bv تركيبات تستوستيرون
EP2854831B1 (en) 2012-06-01 2024-07-10 Ferring B.V. Manufacture of degarelix
US8785426B1 (en) * 2013-12-13 2014-07-22 Upsher-Smith Laboratories, Inc. Testosterone gel compositions and related methods
US20160361322A1 (en) 2015-06-15 2016-12-15 Lipocine Inc. Composition and method for oral delivery of androgen prodrugs
CN107949389A (zh) * 2015-09-30 2018-04-20 富士胶片株式会社 经皮吸收用组合物
TWI857942B (zh) * 2017-10-30 2024-10-11 日商帝國製藥股份有限公司 經皮投與製劑
WO2019140087A1 (en) 2018-01-10 2019-07-18 Celista Pharmaceuticals Llc Testosterone transdermal spray with film
EP3817731B1 (en) 2018-07-05 2025-09-03 Celista Pharmaceuticals Llc Testosterone and estradiol transdermal spray
AU2019308326B2 (en) 2018-07-20 2025-07-31 Lipocine Inc. Liver disease
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US20110039787A1 (en) 2009-07-06 2011-02-17 Ferring International Center S.A. Compositions, kits and methods for treating benign prostate hyperplasia
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EP2447276A1 (en) 2010-10-27 2012-05-02 Ferring B.V. Process for the manufacture of Degarelix and its intermediates
WO2012055903A1 (en) 2010-10-27 2012-05-03 Ferring B.V. Process for the manufacture of degarelix and its intermediates
JO3755B1 (ar) 2011-01-26 2021-01-31 Ferring Bv تركيبات تستوستيرون
CN103841970A (zh) 2011-07-15 2014-06-04 辉凌公司 其中施用匹可硫酸盐组合物的结肠镜检查定时方法

Also Published As

Publication number Publication date
HUE027453T2 (en) 2016-09-28
HRP20160887T1 (hr) 2016-09-23
IL227454A0 (en) 2013-09-30
KR20140041431A (ko) 2014-04-04
US8895053B2 (en) 2014-11-25
HRP20191216T1 (hr) 2019-10-18
WO2012101016A1 (en) 2012-08-02
HUE044327T2 (hu) 2019-10-28
MX2013008463A (es) 2013-10-03
RS59012B1 (sr) 2019-08-30
CN103327962A (zh) 2013-09-25
KR101877476B1 (ko) 2018-07-11
TR201909271T4 (tr) 2019-07-22
US20130295166A1 (en) 2013-11-07
AU2012210691B2 (en) 2016-05-12
EP3072505A1 (en) 2016-09-28
HUS1800036I1 (hu) 2018-09-28
ZA201305665B (en) 2014-03-26
JP6012632B2 (ja) 2016-10-25
ES2741744T3 (es) 2020-02-12
SI3072505T1 (sl) 2019-08-30
HK1192719A1 (zh) 2014-08-29
PL3072505T3 (pl) 2019-12-31
NZ613029A (en) 2014-03-28
DK2667851T3 (en) 2016-07-25
CN103327962B (zh) 2016-04-27
JO3755B1 (ar) 2021-01-31
SA112330224B1 (ar) 2015-02-22
RU2613891C2 (ru) 2017-03-21
JP2017019819A (ja) 2017-01-26
LTPA2018516I1 (lt) 2018-11-12
SI2667851T1 (sl) 2016-07-29
LT3072505T (lt) 2019-08-26
AU2012210691A1 (en) 2013-08-01
CA2824941A1 (en) 2012-08-02
RS54898B1 (sr) 2016-10-31
BR112013018951B1 (pt) 2020-03-10
PL2667851T3 (pl) 2017-01-31
HUE027453T4 (hu) 2018-12-28
EP2667851B1 (en) 2016-05-18
PT2667851T (pt) 2016-07-26
TW201309341A (zh) 2013-03-01
MX340259B (es) 2016-07-04
BR112013018951A2 (pt) 2017-04-04
IL227454A (en) 2017-02-28
RU2013133082A (ru) 2015-03-10
US20150110856A1 (en) 2015-04-23
TWI564029B (zh) 2017-01-01
EP3072505B1 (en) 2019-06-12
DK3072505T3 (da) 2019-08-12
PT3072505T (pt) 2019-07-04
NO2018034I1 (no) 2018-09-27
AR085090A1 (es) 2013-09-11
EP2667851A1 (en) 2013-12-04
JP2014503565A (ja) 2014-02-13

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