CL2013002550A1 - Una formulacion farmaceutica inyectable subcutanea liquida estable altamente concentrada de un anticuerpo anti-her2 farmaceuticamente activo que consiste esencialmente de trastuzumab; his/hci un agente estabilizador y un surfactante no ionico; kit y su uso para tratar enfermedades tales como cancer (divisional de solicitud n°0269-2012). - Google Patents

Una formulacion farmaceutica inyectable subcutanea liquida estable altamente concentrada de un anticuerpo anti-her2 farmaceuticamente activo que consiste esencialmente de trastuzumab; his/hci un agente estabilizador y un surfactante no ionico; kit y su uso para tratar enfermedades tales como cancer (divisional de solicitud n°0269-2012).

Info

Publication number: CL2013002550A1
Authority: CL; Chile
Prior art keywords: trastuzumab; hci; cancer; kit; consisting essentially
Prior art date: 2009-07-31

Application number

CL2013002550A

Other languages

English (en)

Inventor

Michael Adler

Ulla Grauschopf

Hanns-Christian Mahler

Oliver Boris Stauch

Original Assignee

Hoffmann La Roche

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.)

2009-07-31

Filing date

2013-09-05

Publication date

2013-12-13

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=43500473&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CL2013002550(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2013-09-05 Application filed by Hoffmann La Roche filed Critical Hoffmann La Roche

2013-12-13 Publication of CL2013002550A1 publication Critical patent/CL2013002550A1/es

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/47—Hydrolases (3) acting on glycosyl compounds (3.2), e.g. cellulases, lactases
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- 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
- A61K9/08—Solutions
- 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
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y302/00—Hydrolases acting on glycosyl compounds, i.e. glycosylases (3.2)
- C12Y302/01—Glycosidases, i.e. enzymes hydrolysing O- and S-glycosyl compounds (3.2.1)
- C12Y302/01035—Hyaluronoglucosaminidase (3.2.1.35), i.e. hyaluronidase

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Medicinal Chemistry (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Proteomics, Peptides & Aminoacids (AREA)
General Chemical & Material Sciences (AREA)
Chemical Kinetics & Catalysis (AREA)
Oil, Petroleum & Natural Gas (AREA)
Bioinformatics & Cheminformatics (AREA)
Organic Chemistry (AREA)
Immunology (AREA)
Biochemistry (AREA)
Molecular Biology (AREA)
Oncology (AREA)
Microbiology (AREA)
Mycology (AREA)
Genetics & Genomics (AREA)
Dermatology (AREA)
Biophysics (AREA)
Inorganic Chemistry (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Gastroenterology & Hepatology (AREA)
Biomedical Technology (AREA)
General Engineering & Computer Science (AREA)
Wood Science & Technology (AREA)
Zoology (AREA)
Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
Medicinal Preparation (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Peptides Or Proteins (AREA)

CL2013002550A 2009-07-31 2013-09-05 Una formulacion farmaceutica inyectable subcutanea liquida estable altamente concentrada de un anticuerpo anti-her2 farmaceuticamente activo que consiste esencialmente de trastuzumab; his/hci un agente estabilizador y un surfactante no ionico; kit y su uso para tratar enfermedades tales como cancer (divisional de solicitud n°0269-2012). CL2013002550A1 (es)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
EP09167025		2009-07-31

Publications (1)

Publication Number	Publication Date
CL2013002550A1 true CL2013002550A1 (es)	2013-12-13

Family

ID=43500473

Family Applications (2)

Application Number	Title	Priority Date	Filing Date
CL2012000269A CL2012000269A1 (es)	2009-07-31	2012-01-31	Formulacion farmaceutica inyectable subcutanea altamente concentrada de un anticuerpo anti-her2 que comprende dicho anticuerpo, un amortiguador, un estabilizador, un tensioactivo no ionico y una enzima hialuronidasa; dispositivo de inyeccion; kit y uso de la formulacion para tratar enfermedades tales como cancer.
CL2013002550A CL2013002550A1 (es)	2009-07-31	2013-09-05	Una formulacion farmaceutica inyectable subcutanea liquida estable altamente concentrada de un anticuerpo anti-her2 farmaceuticamente activo que consiste esencialmente de trastuzumab; his/hci un agente estabilizador y un surfactante no ionico; kit y su uso para tratar enfermedades tales como cancer (divisional de solicitud n°0269-2012).

Family Applications Before (1)

Application Number	Title	Priority Date	Filing Date
CL2012000269A CL2012000269A1 (es)	2009-07-31	2012-01-31	Formulacion farmaceutica inyectable subcutanea altamente concentrada de un anticuerpo anti-her2 que comprende dicho anticuerpo, un amortiguador, un estabilizador, un tensioactivo no ionico y una enzima hialuronidasa; dispositivo de inyeccion; kit y uso de la formulacion para tratar enfermedades tales como cancer.

Country Status (41)

Country	Link
US (9)	US9345661B2 (es)
EP (4)	EP4339212B1 (es)
JP (2)	JP5462944B2 (es)
KR (2)	KR101413947B1 (es)
CN (3)	CN113967194A (es)
AR (2)	AR077605A1 (es)
AU (1)	AU2010277657B2 (es)
BR (1)	BR112012002080A2 (es)
CA (1)	CA2768458C (es)
CL (2)	CL2012000269A1 (es)
CO (1)	CO6430421A2 (es)
CR (1)	CR20110679A (es)
CY (1)	CY1114185T1 (es)
DK (3)	DK2459167T3 (es)
DO (1)	DOP2015000255A (es)
EA (2)	EA027553B1 (es)
EC (2)	ECSP12011643A (es)
ES (2)	ES2413090T5 (es)
FI (1)	FI2687202T3 (es)
GT (1)	GT201200024A (es)
HK (1)	HK1215157A1 (es)
HR (2)	HRP20130697T4 (es)
HU (1)	HUE062122T2 (es)
IL (2)	IL217382A (es)
IN (1)	IN2012CN00961A (es)
LT (1)	LT2687202T (es)
MA (1)	MA33471B1 (es)
MX (2)	MX355450B (es)
MY (2)	MY172245A (es)
NZ (2)	NZ597190A (es)
PE (2)	PE20120665A1 (es)
PL (2)	PL2687202T3 (es)
PT (2)	PT2687202T (es)
RS (2)	RS52913B2 (es)
SG (2)	SG178185A1 (es)
SI (2)	SI2459167T2 (es)
TN (1)	TN2012000023A1 (es)
TW (2)	TWI401089B (es)
UA (2)	UA102166C2 (es)
WO (1)	WO2011012637A2 (es)
ZA (2)	ZA201109459B (es)

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GT201200024A (es)	2013-10-28
JP5878144B2 (ja)	2016-03-08
EA027553B1 (ru)	2017-08-31
US20160166689A1 (en)	2016-06-16
ZA201109459B (en)	2013-05-29
MX2012001124A (es)	2012-03-29
WO2011012637A3 (en)	2011-08-25
IL217382A (en)	2017-09-28
LT2687202T (lt)	2023-07-10
TWI474834B (zh)	2015-03-01
CY1114185T1 (el)	2016-08-31
IN2012CN00961A (es)	2013-05-24
MX355450B (es)	2018-04-18
CN102573789B (zh)	2015-09-30
PL2459167T3 (pl)	2013-10-31
EP4339212A2 (en)	2024-03-20
MY163001A (en)	2017-07-31
CN102573789A (zh)	2012-07-11
KR101769652B1 (ko)	2017-08-18
CA2768458A1 (en)	2011-02-03
US20260007743A1 (en)	2026-01-08
US20240207400A1 (en)	2024-06-27
US9968676B2 (en)	2018-05-15
WO2011012637A2 (en)	2011-02-03
NZ603900A (en)	2014-03-28
PE20131324A1 (es)	2013-11-04
EP4257150A3 (en)	2023-11-01
US20180228895A1 (en)	2018-08-16
HK1215157A1 (zh)	2016-08-19
SI2459167T2 (sl)	2022-05-31
UA102166C2 (ru)	2013-06-10
ZA201207815B (en)	2013-07-31
JP5462944B2 (ja)	2014-04-02
UA104254C2 (ru)	2014-01-10
KR20130041374A (ko)	2013-04-24
PL2687202T3 (pl)	2023-07-24
PT2459167E (pt)	2013-06-24
ECSP23041058A (es)	2023-07-31
TWI401089B (zh)	2013-07-11
US20130216532A1 (en)	2013-08-22
TN2012000023A1 (en)	2013-09-19
US12427193B2 (en)	2025-09-30
US9345661B2 (en)	2016-05-24
DK4339212T3 (da)	2025-08-25
RS52913B2 (sr)	2022-05-31
US20210353753A1 (en)	2021-11-18
EA031013B1 (ru)	2018-11-30
US20250121059A1 (en)	2025-04-17
PL2459167T5 (pl)	2023-12-11
DK2459167T3 (da)	2013-06-03
SI2687202T1 (sl)	2023-07-31
SI2459167T1 (sl)	2013-07-31
PT2687202T (pt)	2023-06-15
NZ597190A (en)	2012-12-21
ES2948033T3 (es)	2023-08-30
EP4339212A3 (en)	2024-06-19
HK1172236A1 (en)	2013-04-19
HUE062122T2 (hu)	2023-09-28
EA201200204A1 (ru)	2012-08-30
ES2413090T5 (es)	2022-05-03
EA201400270A1 (ru)	2014-06-30
EP4339212B1 (en)	2025-06-25
JP2013500947A (ja)	2013-01-10
EP2459167A2 (en)	2012-06-06
HRP20230462T1 (hr)	2023-07-21
MY172245A (en)	2019-11-19
CO6430421A2 (es)	2012-04-30
RS52913B (sr)	2014-02-28
SG193146A1 (en)	2013-09-30
AU2010277657B2 (en)	2013-05-02
FI2687202T3 (fi)	2023-06-21
TW201328708A (zh)	2013-07-16
EP4257150A2 (en)	2023-10-11
KR20120038540A (ko)	2012-04-23
EP2687202A1 (en)	2014-01-22
CR20110679A (es)	2012-03-06
EP4257150A8 (en)	2025-08-13
JP2013224305A (ja)	2013-10-31
HRP20130697T1 (en)	2013-09-30
CN113967194A (zh)	2022-01-25
DOP2015000255A (es)	2016-01-31
EP2459167B1 (en)	2013-05-15
AU2010277657A1 (en)	2012-02-02
ECSP12011643A (es)	2012-02-29
IL253941B (en)	2021-10-31
HRP20130697T4 (hr)	2022-04-29
TW201106973A (en)	2011-03-01
EP2459167B2 (en)	2022-03-02
IL253941A0 (en)	2017-10-31
SG178185A1 (en)	2012-03-29
MA33471B1 (fr)	2012-07-03
EP2687202B1 (en)	2023-05-10
US20250090660A1 (en)	2025-03-20
AR108936A2 (es)	2018-10-10
KR101413947B1 (ko)	2014-06-30
PE20120665A1 (es)	2012-06-01
US20110044977A1 (en)	2011-02-24
CA2768458C (en)	2013-12-03
ES2413090T3 (es)	2013-07-15
IL217382A0 (en)	2012-02-29
CL2012000269A1 (es)	2012-10-12
BR112012002080A2 (pt)	2016-04-12
CN105168125A (zh)	2015-12-23
WO2011012637A4 (en)	2011-11-03
RS64314B1 (sr)	2023-08-31
DK2687202T3 (da)	2023-07-10
AR077605A1 (es)	2011-09-07

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