DK3383397T3 - Farmaceutiske sammensætninger indeholdende doravirin, tenofovirdisoproxilfumarat og lamivudin - Google Patents

Farmaceutiske sammensætninger indeholdende doravirin, tenofovirdisoproxilfumarat og lamivudin Download PDF

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Publication number
DK3383397T3
DK3383397T3 DK16871332.9T DK16871332T DK3383397T3 DK 3383397 T3 DK3383397 T3 DK 3383397T3 DK 16871332 T DK16871332 T DK 16871332T DK 3383397 T3 DK3383397 T3 DK 3383397T3
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DK
Denmark
Prior art keywords
tenofovirdisoproxilfumarat
doravirin
lamivudin
pharmaceutical compositions
compositions containing
Prior art date
Application number
DK16871332.9T
Other languages
English (en)
Inventor
Santipharp Panmai
Aditya Tatavarti
Andrew M Farrington
Varsha Biyyala
Leonardo R Allain
Marcela Nefliu
Gerard R Klinzing
Jie Ren
Matthew Lamm
Original Assignee
Merck Sharp & Dohme
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=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3383397(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Application granted granted Critical
Publication of DK3383397T3 publication Critical patent/DK3383397T3/da

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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)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
DK16871332.9T 2015-12-02 2016-11-29 Farmaceutiske sammensætninger indeholdende doravirin, tenofovirdisoproxilfumarat og lamivudin DK3383397T3 (da)

Applications Claiming Priority (2)

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

Publications (1)

Publication Number Publication Date
DK3383397T3 true DK3383397T3 (da) 2021-11-08

Family

ID=58797976

Family Applications (1)

Application Number Title Priority Date Filing Date
DK16871332.9T DK3383397T3 (da) 2015-12-02 2016-11-29 Farmaceutiske sammensætninger indeholdende doravirin, tenofovirdisoproxilfumarat og lamivudin

Country Status (21)

Country Link
US (2) US10603282B2 (da)
EP (3) EP3383397B1 (da)
JP (1) JP6866374B2 (da)
KR (1) KR102774942B1 (da)
CN (1) CN108367008B (da)
AU (1) AU2016361612B2 (da)
BR (1) BR112018011085B1 (da)
CA (1) CA3006192C (da)
CY (1) CY1124748T1 (da)
DK (1) DK3383397T3 (da)
ES (1) ES2895951T3 (da)
HR (1) HRP20211687T1 (da)
HU (1) HUE056978T2 (da)
LT (1) LT3383397T (da)
MX (1) MX374931B (da)
PL (1) PL3383397T3 (da)
PT (1) PT3383397T (da)
RS (1) RS62466B1 (da)
RU (1) RU2736941C2 (da)
SI (1) SI3383397T1 (da)
WO (1) WO2017095761A1 (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2736941C2 (ru) * 2015-12-02 2020-11-23 Мерк Шарп энд Доум Корп. Фармацевтические композиции, содержащие доравирин, тенофовира дизопроксила фумарат и ламивудин
RU2019136678A (ru) * 2017-04-18 2021-05-18 Сипла Лимитед Комбинированная терапия для применения в лечении ретровирусных инфекций
PL3746441T3 (pl) * 2018-02-02 2023-07-31 Genentech, Inc. Związek farmaceutyczny, jego sole, jego preparaty oraz sposoby ich wytwarzania i zastosowania
CN115697307A (zh) * 2020-06-19 2023-02-03 葛兰素史密斯克莱知识产权(第2 号)有限公司 包含达普司他的制剂
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
KR20260089535A (ko) 2023-10-12 2026-06-15 머크 샤프 앤드 돔 엘엘씨 도라비린 및 이슬라트라비르를 함유하는 제약 조성물

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
ATE474560T1 (de) * 2005-12-14 2010-08-15 Cipla Ltd Pharmazeutische kombination aus nucleotid und nucleosid-reverse-transkriptase-hemmern (wie tenofovir und lamivudin) in verschiedenen teilen der dosiereinheit
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
MX2012011379A (es) 2010-03-30 2012-11-30 Merck Canada Inc Inhibidores no nucleosidicos de la transcriptasa inversa.
US20140193491A1 (en) * 2011-05-30 2014-07-10 Cipla Limited Pharmaceutical antiretroviral composition
US20140234415A1 (en) * 2013-02-20 2014-08-21 Abbvie Inc. Tablet Dosage Forms
EP3071037A4 (en) 2013-11-22 2017-08-02 Merck Sharp & Dohme Corp. Composition of a non-nucleoside reverse transcriptase inhibitor
WO2015179448A1 (en) * 2014-05-21 2015-11-26 Gilead Sciences, Inc. Therapeutic compounds
RU2736941C2 (ru) * 2015-12-02 2020-11-23 Мерк Шарп энд Доум Корп. Фармацевтические композиции, содержащие доравирин, тенофовира дизопроксила фумарат и ламивудин

Also Published As

Publication number Publication date
MX2018006773A (es) 2018-08-01
RU2736941C2 (ru) 2020-11-23
US20200179291A1 (en) 2020-06-11
EP3960163A1 (en) 2022-03-02
BR112018011085A2 (pt) 2018-11-21
ES2895951T3 (es) 2022-02-23
EP4424373A2 (en) 2024-09-04
RU2018123620A (ru) 2020-01-09
US10842751B2 (en) 2020-11-24
SI3383397T1 (sl) 2021-12-31
CA3006192C (en) 2023-11-28
EP3383397A1 (en) 2018-10-10
CY1124748T1 (el) 2022-07-22
KR20180081082A (ko) 2018-07-13
EP4424373B1 (en) 2025-11-12
RS62466B1 (sr) 2021-11-30
EP3383397A4 (en) 2019-08-07
AU2016361612A1 (en) 2018-05-17
EP4424373A3 (en) 2024-11-06
CN108367008B (zh) 2021-04-30
CN108367008A (zh) 2018-08-03
RU2018123620A3 (da) 2020-03-26
KR102774942B1 (ko) 2025-02-27
PT3383397T (pt) 2021-11-03
JP2018535991A (ja) 2018-12-06
JP6866374B2 (ja) 2021-04-28
US20190254977A1 (en) 2019-08-22
CA3006192A1 (en) 2017-06-08
US10603282B2 (en) 2020-03-31
LT3383397T (lt) 2021-11-25
EP3383397B1 (en) 2021-09-22
HUE056978T2 (hu) 2022-04-28
MX374931B (es) 2025-03-06
PL3383397T3 (pl) 2021-12-27
BR112018011085B1 (pt) 2020-06-02
HRP20211687T1 (hr) 2022-03-04
AU2016361612B2 (en) 2021-07-29
WO2017095761A1 (en) 2017-06-08

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