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DK3145488T3 - Flydende farmaceutiske forbindelse - Google Patents

Flydende farmaceutiske forbindelse Download PDF

Info

Publication number
DK3145488T3
DK3145488T3 DK15723695.1T DK15723695T DK3145488T3 DK 3145488 T3 DK3145488 T3 DK 3145488T3 DK 15723695 T DK15723695 T DK 15723695T DK 3145488 T3 DK3145488 T3 DK 3145488T3
Authority
DK
Denmark
Prior art keywords
liquid pharmaceutical
pharmaceutical compound
compound
liquid
pharmaceutical
Prior art date
Application number
DK15723695.1T
Other languages
English (en)
Inventor
Gianluca Rinaldi
Silvia Fratarcangeli
Rio Alessandra Del
Original Assignee
Fresenius Kabi Deutschland Gmbh
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=50774706&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3145488(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Fresenius Kabi Deutschland Gmbh filed Critical Fresenius Kabi Deutschland Gmbh
Application granted granted Critical
Publication of DK3145488T3 publication Critical patent/DK3145488T3/da

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Transplantation (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK15723695.1T 2014-05-23 2015-05-15 Flydende farmaceutiske forbindelse DK3145488T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP14169755.7A EP2946767B1 (en) 2014-05-23 2014-05-23 Liquid pharmaceutical composition
PCT/EP2015/060818 WO2015177059A1 (en) 2014-05-23 2015-05-15 Liquid pharmaceutical composition

Publications (1)

Publication Number Publication Date
DK3145488T3 true DK3145488T3 (da) 2020-08-10

Family

ID=50774706

Family Applications (3)

Application Number Title Priority Date Filing Date
DK15723695.1T DK3145488T3 (da) 2014-05-23 2015-05-15 Flydende farmaceutiske forbindelse
DKBA202000030U DK202000030Y3 (da) 2014-05-23 2020-04-08 Væskeformig farmaceutisk sammensætning
DKBA202000038U DK202000038Y3 (da) 2014-05-23 2020-05-14 Væskeformig farmaceutisk sammensætning

Family Applications After (2)

Application Number Title Priority Date Filing Date
DKBA202000030U DK202000030Y3 (da) 2014-05-23 2020-04-08 Væskeformig farmaceutisk sammensætning
DKBA202000038U DK202000038Y3 (da) 2014-05-23 2020-05-14 Væskeformig farmaceutisk sammensætning

Country Status (18)

Country Link
US (2) US10426833B2 (da)
EP (4) EP2946767B1 (da)
JP (3) JP2017516848A (da)
CN (2) CN106535935A (da)
AU (3) AU2015263247A1 (da)
CA (2) CA3104940A1 (da)
CY (1) CY1124493T1 (da)
DK (3) DK3145488T3 (da)
ES (2) ES2607489T3 (da)
HK (1) HK1231391A1 (da)
HR (1) HRP20201242T1 (da)
HU (1) HUE050779T2 (da)
IL (2) IL277241B (da)
LT (1) LT3145488T (da)
PT (1) PT3145488T (da)
RS (1) RS60801B1 (da)
SI (1) SI3145488T1 (da)
WO (1) WO2015177059A1 (da)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PL2946765T3 (pl) * 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946766B1 (en) 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
CN105543204A (zh) * 2015-12-30 2016-05-04 海口奇力制药股份有限公司 一种组合物及其应用、含有该组合物的稳定剂
WO2017177160A1 (en) 2016-04-07 2017-10-12 Nevakar Llc Formulation for use in a method of treatment of pain
AU2018255955A1 (en) * 2017-04-18 2019-12-05 Dr. Reddy's Laboratories Limited Stable liquid pharmaceutical composition
US11547686B2 (en) 2017-10-03 2023-01-10 Nevakar Injectables Inc. Acetaminophen pregabalin combinations and methods of treating pain
MX2017016884A (es) * 2017-12-19 2019-06-20 Probiomed S A De C V Formulacion farmaceutica estable de una proteina anti-tnfa.
CA3106669A1 (en) * 2018-07-20 2020-01-30 Momenta Pharmaceuticals, Inc. Compositions of fcrn antibodies and methods of use thereof
WO2024077246A1 (en) * 2022-10-07 2024-04-11 Annexon, Inc. Formulations for anti-c1q antibodies

Family Cites Families (33)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6388197A (ja) 1986-09-30 1988-04-19 Tosoh Corp モノクロナル抗体の安定化方法
MX336813B (es) 1996-02-09 2016-02-02 Abbvie Biotechnology Ltd Anticuerpos humanos que ligan el tnfa humano.
US5900404A (en) 1997-08-15 1999-05-04 Amgen Inc. Chemical modification of proteins to improve biocompatibility and bioactivity
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
HUE030579T2 (en) 2003-04-04 2017-05-29 Genentech Inc High Concentration Antibody And Protein Products
WO2005072772A1 (en) 2004-01-30 2005-08-11 Suomen Punainen Risti Veripalvelu Pharmaceutical compositions
CN101048427B (zh) 2004-07-23 2015-01-14 健泰科生物技术公司 抗体或其片段的结晶
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
ES2424042T3 (es) 2005-06-07 2013-09-26 Esbatech - A Novartis Company Llc Anticuerpos estables y solubles que inhiben TNF±
SG10201604258YA (en) 2007-11-30 2016-07-28 Abbvie Biotechnology Ltd Anti-tnf antibody formulations
US8080518B2 (en) 2007-12-05 2011-12-20 Arbor Vita Corporation Co-administration of an agent linked to an internalization peptide with an anti-inflammatory
RU2481824C2 (ru) * 2008-10-29 2013-05-20 Аблинкс Н.В Препараты однодоменных антигенсвязывающих молекул
SG175188A1 (en) * 2009-05-04 2011-11-28 Abbott Biotech Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
CN107693791B (zh) * 2010-02-26 2022-06-07 诺沃—诺迪斯克有限公司 包含稳定抗体的组合物
CN105521491B (zh) 2010-03-01 2020-03-24 西托戴恩有限公司 浓缩蛋白制剂及其用途
US20110223208A1 (en) 2010-03-09 2011-09-15 Beth Hill Non-Aqueous High Concentration Reduced Viscosity Suspension Formulations
EP2399604A1 (en) 2010-06-25 2011-12-28 F. Hoffmann-La Roche AG Novel antibody formulation
MX344727B (es) 2010-11-11 2017-01-05 Abbvie Biotechnology Ltd Formulaciones liquidas de anticuerpos anti-tnf-alfa de alta concentracion mejoradas.
EP2471554A1 (en) 2010-12-28 2012-07-04 Hexal AG Pharmaceutical formulation comprising a biopharmaceutical drug
US10995130B2 (en) 2011-07-01 2021-05-04 Biogen Ma Inc. Arginine-free TNFR:Fc-fusion polypeptide compositions and methods of use
GB201112429D0 (en) 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
AP2014007922A0 (en) * 2012-03-07 2014-09-30 Cadila Healthcare Ltd Pharmaceutical formulations of TNF-alpha antibodies
WO2013186230A1 (en) 2012-06-12 2013-12-19 Boehringer Ingelheim International Gmbh Pharmaceutical formulation for a therapeutic antibody
EP3701968A1 (en) * 2012-09-07 2020-09-02 Coherus Biosciences, Inc. Stable aqueous formulations of adalimumab
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CA2944330A1 (en) 2014-04-02 2015-10-08 Intas Pharmaceuticals Limited Liquid pharmaceutical composition of adalimumab
PL2946765T3 (pl) 2014-05-23 2017-08-31 Ares Trading S.A. Ciekła kompozycja farmaceutyczna
EP2946766B1 (en) * 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition

Also Published As

Publication number Publication date
US20170182162A1 (en) 2017-06-29
EP3741358A1 (en) 2020-11-25
CN111939257A (zh) 2020-11-17
DK202000038U1 (da) 2020-05-18
AU2020204269A1 (en) 2020-07-16
CA2948746A1 (en) 2015-11-26
CN106535935A (zh) 2017-03-22
AU2020286276A1 (en) 2021-01-14
IL277241B (en) 2022-08-01
HRP20201242T1 (hr) 2020-11-13
US10426833B2 (en) 2019-10-01
US20200155677A1 (en) 2020-05-21
EP2946767A1 (en) 2015-11-25
JP2022174082A (ja) 2022-11-22
WO2015177059A1 (en) 2015-11-26
HUE050779T2 (hu) 2021-01-28
SI3145488T1 (sl) 2020-10-30
DK202000030U1 (da) 2020-04-28
AU2020286276B2 (en) 2023-06-01
IL277241A (en) 2020-10-29
IL249116B (en) 2020-09-30
LT3145488T (lt) 2020-11-25
ES2607489T3 (es) 2017-03-31
HK1231391A1 (zh) 2017-12-22
CY1124493T1 (el) 2022-03-24
RS60801B1 (sr) 2020-10-30
EP3145488B1 (en) 2020-07-22
JP2021107399A (ja) 2021-07-29
DK202000030Y3 (da) 2020-05-26
CA3104940A1 (en) 2015-11-26
CA2948746C (en) 2021-01-12
EP2946767B1 (en) 2016-10-05
DK202000038Y3 (da) 2020-07-10
JP2017516848A (ja) 2017-06-22
PT3145488T (pt) 2020-09-01
AU2020204269B2 (en) 2020-09-17
IL249116A0 (en) 2017-01-31
AU2015263247A1 (en) 2016-12-01
ES2815598T3 (es) 2021-03-30
EP3145488A1 (en) 2017-03-29
EP3939566A1 (en) 2022-01-19

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