AU2013277234B2 - Soluble estradiol capsule for vaginal insertion - Google Patents

Soluble estradiol capsule for vaginal insertion Download PDF

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Publication number
AU2013277234B2
AU2013277234B2 AU2013277234A AU2013277234A AU2013277234B2 AU 2013277234 B2 AU2013277234 B2 AU 2013277234B2 AU 2013277234 A AU2013277234 A AU 2013277234A AU 2013277234 A AU2013277234 A AU 2013277234A AU 2013277234 B2 AU2013277234 B2 AU 2013277234B2
Authority
AU
Australia
Prior art keywords
formulation
estradiol
vaginal
fatty acid
micrograms
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
AU2013277234A
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English (en)
Other versions
AU2013277234A1 (en
Inventor
Julia M. Amadio
Brian A. Bernick
Janice Louise Cacace
Peter H. R. Persicaner
Thorsteinn Thorsteinsson
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.)
TherapeuticsMD Inc
Original Assignee
TherapeuticsMD 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=49769313&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2013277234(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US13/684,002 external-priority patent/US8633178B2/en
Priority claimed from PCT/US2013/023309 external-priority patent/WO2013112947A1/en
Priority claimed from US13/843,428 external-priority patent/US9301920B2/en
Application filed by TherapeuticsMD Inc filed Critical TherapeuticsMD Inc
Publication of AU2013277234A1 publication Critical patent/AU2013277234A1/en
Application granted granted Critical
Publication of AU2013277234B2 publication Critical patent/AU2013277234B2/en
Priority to AU2017208300A priority Critical patent/AU2017208300A1/en
Priority to AU2019204653A priority patent/AU2019204653B2/en
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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/02—Drugs for disorders of the urinary system of urine or of the urinary tract, e.g. urine acidifiers
    • 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
    • A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
    • 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
    • A61P15/04—Drugs for genital or sexual disorders; Contraceptives for inducing labour or abortion; Uterotonics
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Urology & Nephrology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Diabetes (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pregnancy & Childbirth (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
AU2013277234A 2012-06-18 2013-06-18 Soluble estradiol capsule for vaginal insertion Active AU2013277234B2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2017208300A AU2017208300A1 (en) 2012-06-18 2017-07-27 Soluble Estradiol Capsule For Vaginal Insertion
AU2019204653A AU2019204653B2 (en) 2012-06-18 2019-06-28 Soluble Estradiol Capsule For Vaginal Insertion

Applications Claiming Priority (13)

Application Number Priority Date Filing Date Title
US201261661302P 2012-06-18 2012-06-18
US61/661,302 2012-06-18
US201261662265P 2012-06-20 2012-06-20
US61/662,265 2012-06-20
US13/684,002 US8633178B2 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
US13/684,002 2012-11-21
US201261745313P 2012-12-21 2012-12-21
US61/745,313 2012-12-21
PCT/US2013/023309 WO2013112947A1 (en) 2012-01-26 2013-01-25 Transdermal hormone replacement therapies
AUPCT/US2013/023309 2013-01-25
US13/843,428 US9301920B2 (en) 2012-06-18 2013-03-15 Natural combination hormone replacement formulations and therapies
US13/843,428 2013-03-15
PCT/US2013/046443 WO2013192249A1 (en) 2012-06-18 2013-06-18 Soluble estradiol capsule for vaginal insertion

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2017208300A Division AU2017208300A1 (en) 2012-06-18 2017-07-27 Soluble Estradiol Capsule For Vaginal Insertion

Publications (2)

Publication Number Publication Date
AU2013277234A1 AU2013277234A1 (en) 2015-01-22
AU2013277234B2 true AU2013277234B2 (en) 2017-04-27

Family

ID=49769313

Family Applications (3)

Application Number Title Priority Date Filing Date
AU2013277234A Active AU2013277234B2 (en) 2012-06-18 2013-06-18 Soluble estradiol capsule for vaginal insertion
AU2017208300A Abandoned AU2017208300A1 (en) 2012-06-18 2017-07-27 Soluble Estradiol Capsule For Vaginal Insertion
AU2019204653A Ceased AU2019204653B2 (en) 2012-06-18 2019-06-28 Soluble Estradiol Capsule For Vaginal Insertion

Family Applications After (2)

Application Number Title Priority Date Filing Date
AU2017208300A Abandoned AU2017208300A1 (en) 2012-06-18 2017-07-27 Soluble Estradiol Capsule For Vaginal Insertion
AU2019204653A Ceased AU2019204653B2 (en) 2012-06-18 2019-06-28 Soluble Estradiol Capsule For Vaginal Insertion

Country Status (13)

Country Link
EP (2) EP3909586A1 (enExample)
JP (3) JP6397402B2 (enExample)
AU (3) AU2013277234B2 (enExample)
BR (1) BR112014031914B1 (enExample)
CA (1) CA2876968C (enExample)
ES (1) ES2869250T3 (enExample)
HR (1) HRP20210861T1 (enExample)
HU (1) HUE055275T2 (enExample)
IL (1) IL236359B (enExample)
MX (2) MX393195B (enExample)
PL (1) PL2861073T3 (enExample)
RU (2) RU2740059C2 (enExample)
WO (1) WO2013192249A1 (enExample)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9301920B2 (en) 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
RS62297B1 (sr) 2011-11-23 2021-09-30 Therapeuticsmd Inc Prirodne kombinovane hormonske supstitucione formulacije i terapije
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US20150196640A1 (en) 2012-06-18 2015-07-16 Therapeuticsmd, Inc. Progesterone formulations having a desirable pk profile
US10806740B2 (en) 2012-06-18 2020-10-20 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
US10537581B2 (en) 2012-12-21 2020-01-21 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10471072B2 (en) 2012-12-21 2019-11-12 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US10568891B2 (en) 2012-12-21 2020-02-25 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US9180091B2 (en) 2012-12-21 2015-11-10 Therapeuticsmd, Inc. Soluble estradiol capsule for vaginal insertion
US11246875B2 (en) 2012-12-21 2022-02-15 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
US11266661B2 (en) 2012-12-21 2022-03-08 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
JP2017516768A (ja) 2014-05-22 2017-06-22 セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． 天然の併用ホルモン補充療法剤及び療法
US10098894B2 (en) 2014-07-29 2018-10-16 Therapeuticsmd, Inc. Transdermal cream
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
JP2018538290A (ja) * 2015-12-07 2018-12-27 セラピューティックスエムディー インコーポレーテッドＴｈｅｒａｐｅｕｔｉｃｓｍｄ， Ｉｎｃ． 膣挿入エストラジオール医薬組成物および方法
WO2017105512A1 (en) * 2015-12-18 2017-06-22 Proinvet Innovations S.A. Formulations and methods for controlling the reproductive cycle and ovulation
US10286077B2 (en) 2016-04-01 2019-05-14 Therapeuticsmd, Inc. Steroid hormone compositions in medium chain oils
US9931349B2 (en) 2016-04-01 2018-04-03 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
US20220378697A1 (en) * 2019-10-31 2022-12-01 R.P. Scherer Technologies, Llc Suppository capsule

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US694192A (en) * 1901-04-20 1902-02-25 William C Rastetter Vehicle-wheel.
US4384096A (en) * 1979-08-27 1983-05-17 The Dow Chemical Company Liquid emulsion polymers useful as pH responsive thickeners for aqueous systems
US6060077A (en) * 1995-10-05 2000-05-09 Laboratoire Innothera, Societe Anonyme Unit galenical formulation for local hormonotherapy of vaginal dryness
WO2007076144A2 (en) * 2005-12-27 2007-07-05 Duramed Pharmaceuticals, Inc. Conjugated estrogen compositions, applicators, kits, and methods of making and use thereof

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FR2668945B1 (fr) * 1990-11-12 1993-02-19 Theramex Nouveau procede de cristallisation des substances organiques et les composes ainsi obtenus.
GB9405304D0 (en) * 1994-03-16 1994-04-27 Scherer Ltd R P Delivery systems for hydrophobic drugs
FR2728464B1 (fr) * 1994-12-22 1997-04-30 Innothera Lab Sa Forme galenique unitaire, son procede d'obtention et ses utilisations
GB9608719D0 (en) 1996-04-26 1996-07-03 Scherer Ltd R P Pharmaceutical compositions
US6018033A (en) 1997-05-13 2000-01-25 Purdue Research Foundation Hydrophilic, hydrophobic, and thermoreversible saccharide gels and forms, and methods for producing same
NZ330726A (en) * 1998-06-18 2000-10-27 Dec Res Intra-vaginal delivery unit or composition containing a cyclodextrin which improves absorbtion of 17-beta oestradiol or oestradiol benzoate
US6294192B1 (en) * 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
US7374779B2 (en) * 1999-02-26 2008-05-20 Lipocine, Inc. Pharmaceutical formulations and systems for improved absorption and multistage release of active agents
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US20050042268A1 (en) * 2003-07-16 2005-02-24 Chaim Aschkenasy Pharmaceutical composition and method for transdermal drug delivery
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FR2900052B1 (fr) * 2006-04-19 2011-02-18 Galderma Sa Composition comprenant au moins une phase aqueuse et au moins une phase grasse comprenant de l'ivermectine
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US9301920B2 (en) * 2012-06-18 2016-04-05 Therapeuticsmd, Inc. Natural combination hormone replacement formulations and therapies
RS62297B1 (sr) * 2011-11-23 2021-09-30 Therapeuticsmd Inc Prirodne kombinovane hormonske supstitucione formulacije i terapije

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US694192A (en) * 1901-04-20 1902-02-25 William C Rastetter Vehicle-wheel.
US4384096A (en) * 1979-08-27 1983-05-17 The Dow Chemical Company Liquid emulsion polymers useful as pH responsive thickeners for aqueous systems
US6060077A (en) * 1995-10-05 2000-05-09 Laboratoire Innothera, Societe Anonyme Unit galenical formulation for local hormonotherapy of vaginal dryness
WO2007076144A2 (en) * 2005-12-27 2007-07-05 Duramed Pharmaceuticals, Inc. Conjugated estrogen compositions, applicators, kits, and methods of making and use thereof

Also Published As

Publication number Publication date
JP2020100642A (ja) 2020-07-02
RU2020140867A (ru) 2021-06-10
AU2019204653A1 (en) 2019-07-18
AU2019204653B2 (en) 2021-07-08
MX2014015899A (es) 2015-03-03
JP6682127B2 (ja) 2020-04-15
AU2017208300A1 (en) 2017-08-17
BR112014031914B1 (pt) 2021-12-14
CA2876968C (en) 2022-09-13
AU2013277234A1 (en) 2015-01-22
JP2015519405A (ja) 2015-07-09
BR112014031914A2 (pt) 2017-06-27
JP6397402B2 (ja) 2018-09-26
CA2876968A1 (en) 2013-12-27
MX358435B (es) 2018-08-03
EP2861073B1 (en) 2021-04-14
HRP20210861T1 (hr) 2021-09-17
EP2861073A1 (en) 2015-04-22
RU2015100531A (ru) 2016-08-10
WO2013192249A1 (en) 2013-12-27
IL236359B (en) 2020-11-30
PL2861073T3 (pl) 2021-09-27
HUE055275T2 (hu) 2021-11-29
EP3909586A1 (en) 2021-11-17
JP2018199711A (ja) 2018-12-20
IL236359A0 (en) 2015-02-26
EP2861073A4 (en) 2015-12-23
MX393195B (es) 2025-03-24
ES2869250T3 (es) 2021-10-25
RU2740059C2 (ru) 2020-12-31

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