BR112018011085A2 - composições farmacêuticas contendo doravirina, fumarato de tenofovir desoproxila e lamivudina - Google Patents

composições farmacêuticas contendo doravirina, fumarato de tenofovir desoproxila e lamivudina

Info

Publication number
BR112018011085A2
BR112018011085A2 BR112018011085-0A BR112018011085A BR112018011085A2 BR 112018011085 A2 BR112018011085 A2 BR 112018011085A2 BR 112018011085 A BR112018011085 A BR 112018011085A BR 112018011085 A2 BR112018011085 A2 BR 112018011085A2
Authority
BR
Brazil
Prior art keywords
pharmaceutical compositions
desoproxyl
doravirin
tenofovir
lamivudine
Prior art date
Application number
BR112018011085-0A
Other languages
English (en)
Other versions
BR112018011085B1 (pt
Inventor
Panmai Santipharp
Tatavarti Aditya
M. FARRINGTON Andrew
BIYYALA Varsha
R. ALLAIN Leonardo
NEFLIU Marcela
R. KLINZING Gerard
Ren Jie
Lamm Matthew
Original Assignee
Merck Sharp & Dohme Corp.
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=58797976&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=BR112018011085(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp & Dohme Corp. filed Critical Merck Sharp & Dohme Corp.
Publication of BR112018011085A2 publication Critical patent/BR112018011085A2/pt
Publication of BR112018011085B1 publication Critical patent/BR112018011085B1/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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
    • A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4412—Non condensed pyridines; Hydrogenated derivatives thereof having oxo groups directly attached to the heterocyclic ring
    • 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
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
    • A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
    • 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
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
    • 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
    • A61K31/66—Phosphorus compounds
    • A61K31/683—Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • 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
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Virology (AREA)
  • Biophysics (AREA)
  • AIDS & HIV (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

a presente invenção refere-se a composições farmacêuticas compreendendo doravirina, fumarato de tenofovir desoproxila e lamivudina. estas composições são úteis para o tratamento de infecção pelo hiv. também são descritos processos para preparar as ditas composições farmacêuticas.
BR112018011085-0A 2015-12-02 2016-11-29 Composição farmacêutica compreendendo doravirina, fumarato de tenofovir desoproxila e lamivudina e processo para sua preparação BR112018011085B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562261953P 2015-12-02 2015-12-02
US62/261,953 2015-12-02
PCT/US2016/063894 WO2017095761A1 (en) 2015-12-02 2016-11-29 Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine

Publications (2)

Publication Number Publication Date
BR112018011085A2 true BR112018011085A2 (pt) 2018-11-21
BR112018011085B1 BR112018011085B1 (pt) 2020-06-02

Family

ID=58797976

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018011085-0A BR112018011085B1 (pt) 2015-12-02 2016-11-29 Composição farmacêutica compreendendo doravirina, fumarato de tenofovir desoproxila e lamivudina e processo para sua preparação

Country Status (21)

Country Link
US (2) US10603282B2 (pt)
EP (2) EP3383397B1 (pt)
JP (1) JP6866374B2 (pt)
KR (1) KR20180081082A (pt)
CN (1) CN108367008B (pt)
AU (1) AU2016361612B2 (pt)
BR (1) BR112018011085B1 (pt)
CA (1) CA3006192C (pt)
CY (1) CY1124748T1 (pt)
DK (1) DK3383397T3 (pt)
ES (1) ES2895951T3 (pt)
HR (1) HRP20211687T1 (pt)
HU (1) HUE056978T2 (pt)
LT (1) LT3383397T (pt)
MX (1) MX2018006773A (pt)
PL (1) PL3383397T3 (pt)
PT (1) PT3383397T (pt)
RS (1) RS62466B1 (pt)
RU (1) RU2736941C2 (pt)
SI (1) SI3383397T1 (pt)
WO (1) WO2017095761A1 (pt)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2018006773A (es) * 2015-12-02 2018-08-01 Merck Sharp & Dohme Composiciones farmaceuticas que contienen doravirina, tenofovir disoproxil fumarato y lamivudina.
CN110769856A (zh) * 2017-04-18 2020-02-07 希普拉有限公司 用于治疗逆转录病毒感染的组合疗法
WO2019152863A1 (en) * 2018-02-02 2019-08-08 Genentech, Inc. Pharmaceutical compound, salts thereof, formulations thereof, and methods of making and using same
CN113288905A (zh) * 2021-07-14 2021-08-24 石家庄龙泽制药股份有限公司 含多替拉韦钠、拉米夫定和富马酸诺福韦酯的药物组合物
CN115554248B (zh) * 2022-08-25 2023-09-22 平阳润德医院有限公司 一种治疗小儿巨细胞病毒感染性肝炎的肠溶型中药制剂及其制备方法

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5047407A (en) 1989-02-08 1991-09-10 Iaf Biochem International, Inc. 2-substituted-5-substituted-1,3-oxathiolanes with antiviral properties
US5922695A (en) 1996-07-26 1999-07-13 Gilead Sciences, Inc. Antiviral phosphonomethyoxy nucleotide analogs having increased oral bioavarilability
WO2007068934A2 (en) * 2005-12-14 2007-06-21 Cipla Limited Pharmaceutical combination comprising nucleotide and nucleoside reverse transcriptase inhibitors (such as tenofovir and lamivudine) in different parts of the dosage unit
MX2009013565A (es) * 2007-06-12 2010-06-02 Concert Pharmaceuticals Inc Derivados de azapeptidos.
WO2009106960A2 (en) * 2008-02-27 2009-09-03 Aurobindo Pharma Limited Stable compositions of lamivudine, tenofovir and efavirenz
EP2295038B1 (en) 2009-09-11 2013-05-29 AiCuris GmbH & Co. KG Solid dispersion comprising an anti-HIV agent
SI2552902T1 (sl) 2010-03-30 2015-10-30 Merck Canada Inc. Inhibitorji ne-nukleozidne reverzne transkriptaze
AU2012264475A1 (en) * 2011-05-30 2013-10-31 Cipla Limited Pharmaceutical antiretroviral composition
WO2014130553A2 (en) * 2013-02-20 2014-08-28 Abbvie Inc. Tablet dosage forms
JP6387094B2 (ja) * 2013-11-22 2018-09-05 メルク・シャープ・アンド・ドーム・コーポレーションＭｅｒｃｋ Ｓｈａｒｐ ＆ Ｄｏｈｍｅ Ｃｏｒｐ． 非ヌクレオシド逆転写酵素阻害剤の組成物
WO2015179448A1 (en) * 2014-05-21 2015-11-26 Gilead Sciences, Inc. Therapeutic compounds
MX2018006773A (es) * 2015-12-02 2018-08-01 Merck Sharp & Dohme Composiciones farmaceuticas que contienen doravirina, tenofovir disoproxil fumarato y lamivudina.

Also Published As

Publication number Publication date
US10603282B2 (en) 2020-03-31
US20190254977A1 (en) 2019-08-22
KR20180081082A (ko) 2018-07-13
EP3383397A1 (en) 2018-10-10
PT3383397T (pt) 2021-11-03
HUE056978T2 (hu) 2022-04-28
DK3383397T3 (da) 2021-11-08
WO2017095761A1 (en) 2017-06-08
SI3383397T1 (sl) 2021-12-31
PL3383397T3 (pl) 2021-12-27
AU2016361612B2 (en) 2021-07-29
BR112018011085B1 (pt) 2020-06-02
MX2018006773A (es) 2018-08-01
RU2018123620A3 (pt) 2020-03-26
EP3383397A4 (en) 2019-08-07
EP3383397B1 (en) 2021-09-22
CN108367008A (zh) 2018-08-03
CY1124748T1 (el) 2022-07-22
RU2018123620A (ru) 2020-01-09
AU2016361612A1 (en) 2018-05-17
RS62466B1 (sr) 2021-11-30
RU2736941C2 (ru) 2020-11-23
JP6866374B2 (ja) 2021-04-28
CN108367008B (zh) 2021-04-30
US10842751B2 (en) 2020-11-24
LT3383397T (lt) 2021-11-25
JP2018535991A (ja) 2018-12-06
US20200179291A1 (en) 2020-06-11
CA3006192C (en) 2023-11-28
EP3960163A1 (en) 2022-03-02
ES2895951T3 (es) 2022-02-23
HRP20211687T1 (hr) 2022-03-04
CA3006192A1 (en) 2017-06-08

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B65Y Grant of priority examination of the patent application (request complies with dec. 132/06 of 20061117)
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 29/11/2016, OBSERVADAS AS CONDICOES LEGAIS.

B25A Requested transfer of rights approved

Owner name: MERCK SHARP AND DOHME LLC (US)