BR112014031914A2 - cápsula de estradiol solúvel para inserção vaginal - Google Patents

cápsula de estradiol solúvel para inserção vaginal

Info

Publication number
BR112014031914A2
BR112014031914A2 BR112014031914A BR112014031914A BR112014031914A2 BR 112014031914 A2 BR112014031914 A2 BR 112014031914A2 BR 112014031914 A BR112014031914 A BR 112014031914A BR 112014031914 A BR112014031914 A BR 112014031914A BR 112014031914 A2 BR112014031914 A2 BR 112014031914A2
Authority
BR
Brazil
Prior art keywords
vaginal insertion
capsule
soluble
soluble estradiol
estradiol capsule
Prior art date
Application number
BR112014031914A
Other languages
English (en)
Other versions
BR112014031914B1 (pt
Inventor
A Bernick Brian
Louise Cacace Janice
M Amadio Julia
H R Persicaner Peter
Thorsteinsson Thorsteinn
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=BR112014031914(A2) "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 BR112014031914A2 publication Critical patent/BR112014031914A2/pt
Publication of BR112014031914B1 publication Critical patent/BR112014031914B1/pt

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)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Endocrinology (AREA)
  • Reproductive Health (AREA)
  • Gynecology & Obstetrics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Urology & Nephrology (AREA)
  • Diabetes (AREA)
  • Pregnancy & Childbirth (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Steroid Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

resumo "cápsula de estradiol solúvel para inserção vaginal" de acordo com várias modalidades dessa revelação, são fornecidas formu-lações farmacêuticas que compreendem estradiol solubilizado. em várias modali-dades, tais formulações são encapsuladas em cápsulas moles que podem ser inse-ridas na vagina para o tratamento da atrofia vulvovaginal.
BR112014031914-6A 2012-06-18 2013-06-18 Formulação farmacêutica encapsulada para liberação intravaginal compreendendo estradiol e uso da mesma para o tratamento de atrofia vulvovaginal e de um sistoma associado, bem como de um estado urinário deficiente em estrogênio BR112014031914B1 (pt)

Applications Claiming Priority (12)

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 2012-11-21
US13/684,002 US8633178B2 (en) 2011-11-23 2012-11-21 Natural combination hormone replacement formulations and therapies
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
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

Publications (2)

Publication Number Publication Date
BR112014031914A2 true BR112014031914A2 (pt) 2017-06-27
BR112014031914B1 BR112014031914B1 (pt) 2021-12-14

Family

ID=49769313

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014031914-6A BR112014031914B1 (pt) 2012-06-18 2013-06-18 Formulação farmacêutica encapsulada para liberação intravaginal compreendendo estradiol e uso da mesma para o tratamento de atrofia vulvovaginal e de um sistoma associado, bem como de um estado urinário deficiente em estrogênio

Country Status (13)

Country Link
EP (2) EP2861073B1 (pt)
JP (3) JP6397402B2 (pt)
AU (3) AU2013277234B2 (pt)
BR (1) BR112014031914B1 (pt)
CA (1) CA2876968C (pt)
ES (1) ES2869250T3 (pt)
HR (1) HRP20210861T1 (pt)
HU (1) HUE055275T2 (pt)
IL (1) IL236359B (pt)
MX (1) MX358435B (pt)
PL (1) PL2861073T3 (pt)
RU (2) RU2740059C2 (pt)
WO (1) WO2013192249A1 (pt)

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
JP6285866B2 (ja) 2011-11-23 2018-02-28 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． 天然複合ホルモン補充製剤および療法
US20130338122A1 (en) 2012-06-18 2013-12-19 Therapeuticsmd, Inc. Transdermal hormone replacement therapies
US10806697B2 (en) 2012-12-21 2020-10-20 Therapeuticsmd, Inc. Vaginal inserted estradiol pharmaceutical compositions and methods
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
US11266661B2 (en) 2012-12-21 2022-03-08 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
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
KR20170005819A (ko) 2014-05-22 2017-01-16 쎄러퓨틱스엠디, 인코퍼레이티드 천연 복합 호르몬 대체 제형 및 요법
RU2016141135A (ru) 2014-07-29 2018-08-28 Терапьютиксмд, Инк. Трансдермальный крем
US10328087B2 (en) 2015-07-23 2019-06-25 Therapeuticsmd, Inc. Formulations for solubilizing hormones
KR20180100567A (ko) * 2015-12-07 2018-09-11 쎄러퓨틱스엠디, 인코퍼레이티드 질 삽입식 에스트라디올 약제학적 조성물 및 방법
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
WO2017173071A1 (en) 2016-04-01 2017-10-05 Therapeuticsmd, Inc. Steroid hormone pharmaceutical composition
CA3159370A1 (en) * 2019-10-31 2021-05-06 R.P. Scherer Technologies, Llc Suppository capsule

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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.
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FR2728464B1 (fr) * 1994-12-22 1997-04-30 Innothera Lab Sa Forme galenique unitaire, son procede d'obtention et ses utilisations
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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
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JP6285866B2 (ja) * 2011-11-23 2018-02-28 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． 天然複合ホルモン補充製剤および療法

Also Published As

Publication number Publication date
JP2015519405A (ja) 2015-07-09
AU2019204653B2 (en) 2021-07-08
HUE055275T2 (hu) 2021-11-29
AU2019204653A1 (en) 2019-07-18
JP2018199711A (ja) 2018-12-20
MX358435B (es) 2018-08-03
AU2017208300A1 (en) 2017-08-17
JP6682127B2 (ja) 2020-04-15
JP6397402B2 (ja) 2018-09-26
PL2861073T3 (pl) 2021-09-27
EP2861073A1 (en) 2015-04-22
EP3909586A1 (en) 2021-11-17
IL236359B (en) 2020-11-30
ES2869250T3 (es) 2021-10-25
EP2861073B1 (en) 2021-04-14
MX2014015899A (es) 2015-03-03
CA2876968C (en) 2022-09-13
AU2013277234B2 (en) 2017-04-27
BR112014031914B1 (pt) 2021-12-14
AU2013277234A1 (en) 2015-01-22
IL236359A0 (en) 2015-02-26
HRP20210861T1 (hr) 2021-09-17
CA2876968A1 (en) 2013-12-27
WO2013192249A1 (en) 2013-12-27
EP2861073A4 (en) 2015-12-23
RU2020140867A (ru) 2021-06-10
RU2015100531A (ru) 2016-08-10
JP2020100642A (ja) 2020-07-02
RU2740059C2 (ru) 2020-12-31

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B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06I Publication of requirement cancelled [chapter 6.9 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 6.6.1 NA RPI NO 2462 DE 13/03/2018 POR TER SIDO INDEVIDA.

B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B15K Others concerning applications: alteration of classification

Free format text: A CLASSIFICACAO ANTERIOR ERA: A01N 45/00

Ipc: A61K 31/565 (2006.01), A61K 47/14 (2017.01), A61K

B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

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