IL305910B2 - Formulation of an oral dosage form of }]5–(3–chlorophenyl)–3–hydroxypyridine–2–carbonyl[amino{acetic acid - Google Patents

Formulation of an oral dosage form of }]5–(3–chlorophenyl)–3–hydroxypyridine–2–carbonyl[amino{acetic acid

Info

Publication number
IL305910B2
IL305910B2 IL305910A IL30591023A IL305910B2 IL 305910 B2 IL305910 B2 IL 305910B2 IL 305910 A IL305910 A IL 305910A IL 30591023 A IL30591023 A IL 30591023A IL 305910 B2 IL305910 B2 IL 305910B2
Authority
IL
Israel
Prior art keywords
tablet formulation
weight
kidney disease
chronic kidney
granular
Prior art date
Application number
IL305910A
Other languages
English (en)
Hebrew (he)
Other versions
IL305910A (en
IL305910B1 (en
Inventor
Alexander Smith
Gurudatt Ajay Chandorkar
Ene Ikpong Ette
Bradley John Maroni
Charlotte Suzanne Hartman
Ramin Farzaneh-Far
Jula Kern Inrig
Original Assignee
Akebia Therapeutics Inc
Alexander Smith
Gurudatt Ajay Chandorkar
Ene Ikpong Ette
Bradley John Maroni
Charlotte Suzanne Hartman
Farzaneh Far Ramin
Jula Kern Inrig
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=57006457&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IL305910(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Akebia Therapeutics Inc, Alexander Smith, Gurudatt Ajay Chandorkar, Ene Ikpong Ette, Bradley John Maroni, Charlotte Suzanne Hartman, Farzaneh Far Ramin, Jula Kern Inrig filed Critical Akebia Therapeutics Inc
Publication of IL305910A publication Critical patent/IL305910A/en
Publication of IL305910B1 publication Critical patent/IL305910B1/en
Publication of IL305910B2 publication Critical patent/IL305910B2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4418Non condensed pyridines; Hydrogenated derivatives thereof having a carbocyclic group directly attached to the heterocyclic ring, e.g. cyproheptadine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2072Pills, 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
    • A61K9/2077Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806Coating materials
    • A61K9/2833Organic macromolecular compounds
    • A61K9/286Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D213/00Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/60Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D213/78Carbon atoms having three bonds to hetero atoms, with at the most one bond to halogen, e.g. ester or nitrile radicals
    • C07D213/81Amides; Imides

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
IL305910A 2015-04-01 2016-03-31 Formulation of an oral dosage form of }]5–(3–chlorophenyl)–3–hydroxypyridine–2–carbonyl[amino{acetic acid IL305910B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562141420P 2015-04-01 2015-04-01
US201562270168P 2015-12-21 2015-12-21
PCT/US2016/025235 WO2016161094A1 (en) 2015-04-01 2016-03-31 Compositions and methods for treating anemia

Publications (3)

Publication Number Publication Date
IL305910A IL305910A (en) 2023-11-01
IL305910B1 IL305910B1 (en) 2024-12-01
IL305910B2 true IL305910B2 (en) 2025-04-01

Family

ID=57006457

Family Applications (3)

Application Number Title Priority Date Filing Date
IL305910A IL305910B2 (en) 2015-04-01 2016-03-31 Formulation of an oral dosage form of }]5–(3–chlorophenyl)–3–hydroxypyridine–2–carbonyl[amino{acetic acid
IL292262A IL292262B2 (en) 2015-04-01 2016-03-31 Formulation of an oral administration form of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid
IL254710A IL254710B (en) 2015-04-01 2017-09-26 Oral dosage formulation of {[ 5-(3-(chlorophenyl)- 3-hydroxypyridine-2-carbonyl] amino} acetic acid

Family Applications After (2)

Application Number Title Priority Date Filing Date
IL292262A IL292262B2 (en) 2015-04-01 2016-03-31 Formulation of an oral administration form of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid
IL254710A IL254710B (en) 2015-04-01 2017-09-26 Oral dosage formulation of {[ 5-(3-(chlorophenyl)- 3-hydroxypyridine-2-carbonyl] amino} acetic acid

Country Status (35)

Country Link
US (3) US11324734B2 (https=)
EP (2) EP3995138A1 (https=)
JP (4) JP6929785B2 (https=)
KR (3) KR20250150155A (https=)
CN (2) CN107645953B (https=)
AU (3) AU2016243700B2 (https=)
BR (1) BR112017021097B1 (https=)
CL (2) CL2017002456A1 (https=)
CO (1) CO2017011200A2 (https=)
CR (2) CR20210248A (https=)
CU (1) CU20170126A7 (https=)
CY (1) CY1124869T1 (https=)
DK (1) DK3277270T3 (https=)
EA (1) EA036920B1 (https=)
EC (1) ECSP17073209A (https=)
ES (1) ES2900481T3 (https=)
HR (1) HRP20211862T1 (https=)
HU (1) HUE056958T2 (https=)
IL (3) IL305910B2 (https=)
LT (1) LT3277270T (https=)
MA (1) MA41863A (https=)
MX (3) MX374909B (https=)
MY (1) MY192705A (https=)
NZ (1) NZ735973A (https=)
PE (1) PE20180189A1 (https=)
PH (1) PH12017501789B1 (https=)
PL (1) PL3277270T3 (https=)
PT (1) PT3277270T (https=)
SA (1) SA517390054B1 (https=)
SG (1) SG11201707994UA (https=)
SI (1) SI3277270T1 (https=)
TW (5) TW202602440A (https=)
UA (1) UA123308C2 (https=)
WO (1) WO2016161094A1 (https=)
ZA (2) ZA201706681B (https=)

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AR099354A1 (es) 2013-11-15 2016-07-20 Akebia Therapeutics Inc Formas sólidas de ácido {[5-(3-clorofenil)-3-hidroxipiridin-2-carbonil]amino}acético, composiciones, y sus usos
AU2016209126A1 (en) 2015-01-23 2017-08-10 Akebia Therapeutics, Inc. Solid forms of 2-(5-(3-fluorophenyl)-3-hydroxypicolinamido)acetic acid, compositions, and uses thereof
US11324734B2 (en) 2015-04-01 2022-05-10 Akebia Therapeutics, Inc. Compositions and methods for treating anemia
JP6864834B2 (ja) * 2017-06-14 2021-04-28 ニプロ株式会社 投与量決定プログラムおよび投与量決定装置
WO2019028150A1 (en) 2017-08-01 2019-02-07 Akebia Therapeutics, Inc. COMPOSITIONS FOR USE IN METHODS OF TREATING HEMOGLOBINOPATHIES
EP3790863A1 (en) 2018-05-09 2021-03-17 Akebia Therapeutics Inc. Process for preparing 2-[[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino]acetic acid
WO2021087144A1 (en) * 2019-10-31 2021-05-06 Akebia Therapeutics, Inc. Therapeutic methods using vadadustat
US11524939B2 (en) 2019-11-13 2022-12-13 Akebia Therapeutics, Inc. Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino} acetic acid
WO2021186356A1 (en) * 2020-03-17 2021-09-23 Cadila Healthcare Limited Formulation comprising hif prolyl hydroxylase inhibitors
TW202206065A (zh) * 2020-04-29 2022-02-16 美商百愛及生物醫藥公司 用以治療老化相關病況之缺氧誘導因子脯胺醯羥化酶抑制劑
US20230225977A1 (en) * 2020-06-19 2023-07-20 Glaxosmithkline Intellectual Property (No.2) Limited Formulation comprising daprodustat
KR20230027157A (ko) 2020-06-19 2023-02-27 아케비아 테라퓨틱스 인코포레이티드 바다두스타트의 약물-약물 상호작용의 조절
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WO2022150623A1 (en) 2021-01-08 2022-07-14 Akebia Therapeutics, Inc. Compounds and composition for the treatment of anemia
WO2022150621A1 (en) 2021-01-08 2022-07-14 Akebia Therapeutics, Inc. Therapeutic methods using vadadustat
EP4301352A1 (en) 2021-03-01 2024-01-10 Akebia Therapeutics Inc. Modulation of drug-drug interactions of vadadustat
CN119868550A (zh) * 2023-10-24 2025-04-25 杭州安道药业有限公司 缺氧诱导因子-脯酰胺羟基化酶抑制剂(hif-phi)在罕见贫血中的应用

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