AU2013203445C1 - Pharmaceutical compositions containing dimethyl fumarate - Google Patents

Pharmaceutical compositions containing dimethyl fumarate Download PDF

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Publication number
AU2013203445C1
AU2013203445C1 AU2013203445A AU2013203445A AU2013203445C1 AU 2013203445 C1 AU2013203445 C1 AU 2013203445C1 AU 2013203445 A AU2013203445 A AU 2013203445A AU 2013203445 A AU2013203445 A AU 2013203445A AU 2013203445 C1 AU2013203445 C1 AU 2013203445C1
Authority
AU
Australia
Prior art keywords
dosage form
oral dosage
solid oral
methyl
dmf
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.)
Ceased
Application number
AU2013203445A
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English (en)
Other versions
AU2013203445A1 (en
AU2013203445B2 (en
Inventor
Katherine DAWSON
David Goldman
Ajay Nirula
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.)
Biogen MA Inc
Original Assignee
Biogen MA 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=48947963&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AU2013203445(C1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biogen MA Inc filed Critical Biogen MA Inc
Priority to AU2013204286A priority Critical patent/AU2013204286B2/en
Publication of AU2013203445A1 publication Critical patent/AU2013203445A1/en
Assigned to BIOGEN MA INC. reassignment BIOGEN MA INC. Amend patent request/document other than specification (104) Assignors: BIOGEN IDEC MA INC.
Publication of AU2013203445B2 publication Critical patent/AU2013203445B2/en
Priority to AU2017200394A priority patent/AU2017200394B2/en
Publication of AU2013203445C1 publication Critical patent/AU2013203445C1/en
Application granted granted Critical
Priority to AU2017208367A priority patent/AU2017208367A1/en
Priority to AU2018260937A priority patent/AU2018260937B2/en
Priority to AU2020244395A priority patent/AU2020244395B2/en
Ceased 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • 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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/612—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid
    • A61K31/616—Salicylic acid; Derivatives thereof having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid by carboxylic acids, e.g. acetylsalicylic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone
    • A61K9/2846—Poly(meth)acrylates
    • 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
    • A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Emergency Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Rheumatology (AREA)
  • Dermatology (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
AU2013203445A 2012-02-07 2013-02-06 Pharmaceutical compositions containing dimethyl fumarate Ceased AU2013203445C1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
AU2013204286A AU2013204286B2 (en) 2012-02-07 2013-04-12 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017200394A AU2017200394B2 (en) 2012-02-07 2017-01-20 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017208367A AU2017208367A1 (en) 2012-02-07 2017-07-28 Pharmaceutical compositions containing dimethyl fumarate
AU2018260937A AU2018260937B2 (en) 2012-02-07 2018-11-09 Pharmaceutical compositions containing dimethyl fumarate
AU2020244395A AU2020244395B2 (en) 2012-02-07 2020-09-28 Pharmaceutical compositions containing dimethyl fumarate

Applications Claiming Priority (7)

Application Number Priority Date Filing Date Title
US201261596202P 2012-02-07 2012-02-07
US61/596,202 2012-02-07
US201261625621P 2012-04-17 2012-04-17
US61/625,621 2012-04-17
US201261723048P 2012-11-06 2012-11-06
US61/723,048 2012-11-06
PCT/US2013/024946 WO2013119677A1 (en) 2012-02-07 2013-02-06 Pharmaceutical compositions containing dimethyl fumarate

Related Child Applications (2)

Application Number Title Priority Date Filing Date
AU2013204286A Division AU2013204286B2 (en) 2012-02-07 2013-04-12 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017200394A Division AU2017200394B2 (en) 2012-02-07 2017-01-20 Pharmaceutical Compositions Containing Dimethyl Fumarate

Publications (3)

Publication Number Publication Date
AU2013203445A1 AU2013203445A1 (en) 2013-08-22
AU2013203445B2 AU2013203445B2 (en) 2016-10-20
AU2013203445C1 true AU2013203445C1 (en) 2017-04-20

Family

ID=48947963

Family Applications (6)

Application Number Title Priority Date Filing Date
AU2013203445A Ceased AU2013203445C1 (en) 2012-02-07 2013-02-06 Pharmaceutical compositions containing dimethyl fumarate
AU2013204286A Ceased AU2013204286B2 (en) 2012-02-07 2013-04-12 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017200394A Ceased AU2017200394B2 (en) 2012-02-07 2017-01-20 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017208367A Abandoned AU2017208367A1 (en) 2012-02-07 2017-07-28 Pharmaceutical compositions containing dimethyl fumarate
AU2018260937A Ceased AU2018260937B2 (en) 2012-02-07 2018-11-09 Pharmaceutical compositions containing dimethyl fumarate
AU2020244395A Expired - Fee Related AU2020244395B2 (en) 2012-02-07 2020-09-28 Pharmaceutical compositions containing dimethyl fumarate

Family Applications After (5)

Application Number Title Priority Date Filing Date
AU2013204286A Ceased AU2013204286B2 (en) 2012-02-07 2013-04-12 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017200394A Ceased AU2017200394B2 (en) 2012-02-07 2017-01-20 Pharmaceutical Compositions Containing Dimethyl Fumarate
AU2017208367A Abandoned AU2017208367A1 (en) 2012-02-07 2017-07-28 Pharmaceutical compositions containing dimethyl fumarate
AU2018260937A Ceased AU2018260937B2 (en) 2012-02-07 2018-11-09 Pharmaceutical compositions containing dimethyl fumarate
AU2020244395A Expired - Fee Related AU2020244395B2 (en) 2012-02-07 2020-09-28 Pharmaceutical compositions containing dimethyl fumarate

Country Status (24)

Country Link
US (7) US20130216615A1 (enExample)
EP (1) EP2811994A4 (enExample)
JP (4) JP6189333B2 (enExample)
KR (1) KR102105217B1 (enExample)
CN (5) CN104220061A (enExample)
AR (1) AR089931A1 (enExample)
AU (6) AU2013203445C1 (enExample)
BR (1) BR112014019462B1 (enExample)
CA (1) CA2862885C (enExample)
CL (1) CL2014002077A1 (enExample)
CO (1) CO7141407A2 (enExample)
EA (1) EA038152B1 (enExample)
EC (1) ECSP14014870A (enExample)
HK (1) HK1202261A1 (enExample)
IL (2) IL233833B (enExample)
MX (2) MX393165B (enExample)
NI (1) NI201400086A (enExample)
NZ (1) NZ627980A (enExample)
PE (1) PE20150092A1 (enExample)
PH (1) PH12014501750A1 (enExample)
SG (1) SG11201404705YA (enExample)
TW (4) TWI676475B (enExample)
WO (1) WO2013119677A1 (enExample)
ZA (1) ZA201405511B (enExample)

Cited By (1)

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US11052062B2 (en) 2004-10-08 2021-07-06 Biogen Swiss Manufacturing Gmbh Controlled release pharmaceutical compositions comprising a fumaric acid ester

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Citations (7)

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