DK4218797T5 - Stabiliseret væske og frysetørrede adamts13-formuleringer - Google Patents

Stabiliseret væske og frysetørrede adamts13-formuleringer

Info

Publication number: DK4218797T5
Authority: DK; Denmark
Prior art keywords: lyfo; dried; stabilized liquid; adamts13 formulations; adamts13
Prior art date: 2009-09-21

Application number

DK23172759.5T

Other languages

English (en)

Other versions

DK4218797T3 (da

Inventor

Peter Turecek

Hans-Peter Schwarz

H Peter Matthiessen

Original Assignee

Takeda Pharmaceuticals Co

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.)

2009-09-21

Filing date

2010-09-21

Publication date

2025-07-21

2010-09-21 Application filed by Takeda Pharmaceuticals Co filed Critical Takeda Pharmaceuticals Co

2024-12-09 Application granted granted Critical

2024-12-09 Publication of DK4218797T3 publication Critical patent/DK4218797T3/da

2025-07-21 Publication of DK4218797T5 publication Critical patent/DK4218797T5/da

Classifications

- 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)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/4886—Metalloendopeptidases (3.4.24), e.g. collagenase
- 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
- A61K47/02—Inorganic compounds
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- 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
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- 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
- 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
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
- 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
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/24—Metalloendopeptidases (3.4.24)
- C12Y304/24087—ADAMTS13 endopeptidase (3.4.24.87)
- 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
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Medicinal Chemistry (AREA)
Animal Behavior & Ethology (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Bioinformatics & Cheminformatics (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Oil, Petroleum & Natural Gas (AREA)
Organic Chemistry (AREA)
Biochemistry (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Immunology (AREA)
Inorganic Chemistry (AREA)
Gastroenterology & Hepatology (AREA)
Molecular Biology (AREA)
Genetics & Genomics (AREA)
Wood Science & Technology (AREA)
Zoology (AREA)
General Engineering & Computer Science (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Heart & Thoracic Surgery (AREA)
Cardiology (AREA)
Diabetes (AREA)
Urology & Nephrology (AREA)
Hematology (AREA)
Vascular Medicine (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Enzymes And Modification Thereof (AREA)
Medicinal Preparation (AREA)
Dermatology (AREA)
Dispersion Chemistry (AREA)
Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Peptides Or Proteins (AREA)

DK23172759.5T 2009-09-21 2010-09-21 Stabiliseret væske og frysetørrede adamts13-formuleringer DK4218797T5 (da)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US24435309P	2009-09-21	2009-09-21
EP20211228.0A EP3834841B1 (en)	2009-09-21	2010-09-21	Stabilized liquid and lyophilized adamts13 formulations

Publications (2)

Publication Number	Publication Date
DK4218797T3 DK4218797T3 (da)	2024-12-09
DK4218797T5 true DK4218797T5 (da)	2025-07-21

Family

ID=43598388

Family Applications (4)

Application Number	Title	Priority Date	Filing Date
DK10759786.6T DK2480198T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer
DK15203085.4T DK3167897T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer
DK23172759.5T DK4218797T5 (da)	2009-09-21	2010-09-21	Stabiliseret væske og frysetørrede adamts13-formuleringer
DK20211228.0T DK3834841T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer

Family Applications Before (2)

Application Number	Title	Priority Date	Filing Date
DK10759786.6T DK2480198T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige- og lyofiliserede adamts13-formuleringer
DK15203085.4T DK3167897T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer

Family Applications After (1)

Application Number	Title	Priority Date	Filing Date
DK20211228.0T DK3834841T3 (da)	2009-09-21	2010-09-21	Stabiliserede væskeformige og lyofiliserede adamts13-formuleringer

Country Status (21)

Country	Link
US (9)	US8623352B2 (da)
EP (5)	EP4218797B9 (da)
JP (2)	JP5819303B2 (da)
KR (6)	KR20250008986A (da)
CN (2)	CN104224705B (da)
AU (1)	AU2010295299B2 (da)
BR (1)	BR112012006283B1 (da)
CA (1)	CA2774556A1 (da)
DK (4)	DK2480198T3 (da)
EA (1)	EA024267B1 (da)
ES (4)	ES3001509T3 (da)
FI (2)	FI3834841T3 (da)
FR (1)	FR24C1049I2 (da)
HR (1)	HRP20160295T1 (da)
HU (1)	HUE028688T2 (da)
IN (1)	IN2012DN02645A (da)
MX (3)	MX362382B (da)
NZ (1)	NZ598839A (da)
PL (4)	PL2480198T3 (da)
PT (2)	PT4218797T (da)
WO (1)	WO2011035335A2 (da)

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EP3388529A1 (en)	2008-12-05	2018-10-17	Baxalta GmbH	Methods of measuring adamts13-mediated in vivo cleavage of von willebrand factor and uses thereof
AU2010295299B2 (en)	2009-09-21	2015-12-24	Takeda Pharmaceutical Company Limited	Stabilized liquid and lyophilized ADAMTS13 formulations
DK2814514T3 (da) *	2012-02-16	2017-12-18	Atyr Pharma Inc	Histidyl-tRNA-synthetaser til behandling af autoimmune og inflammatoriske sygdomme
CN103566362B (zh) *	2012-07-21	2015-07-29	复旦大学	重组adamts13在制备脑出血药物中的用途
WO2014075033A2 (en)	2012-11-09	2014-05-15	Puget Sound Blood Center	Protein stabilizing factors
AU2013203062C1 (en) *	2013-03-15	2018-06-28	Takeda Pharmaceutical Company Limited	Subcutaneous administration of adamts13
ES2847383T3 (es)	2013-03-15	2021-08-03	Atyr Pharma Inc	Conjugados de Fc-histidil-ARNt sintetasa
AU2015280480A1 (en) *	2014-06-26	2017-01-05	Amgen Inc.	Protein formulations
GB201510870D0 (en) *	2015-05-26	2015-08-05	Baxalta Inc And Katholieke Universiteit Leuven And Baxalta Gmbh	Treatment of infarction
ES2983978T3 (es)	2016-01-08	2024-10-28	Univ Kyoto	Medicina que comprende ADAMTS13 como ingrediente principal
KR20230079461A (ko)	2016-08-04	2023-06-07	다케다 파머수티컬 컴패니 리미티드	급성 폐 손상 및/또는 급성 호흡 곤란 증후군에서 혈관폐색 위기의 치료, 개선 및/또는 예방을 위한 adamts13의 용도
ES2981519T3 (es)	2016-11-04	2024-10-09	Takeda Pharmaceuticals Co	Formulaciones de virus adeno-asociados
EP3612215B1 (en)	2017-04-20	2024-08-28	aTyr Pharma, Inc.	Compositions for treating lung inflammation
UA125971C2 (uk) *	2017-07-25	2022-07-20	Джянгсу Хенгруй Медісін Ко., Лтд.	Фармацевтична композиція, яка містить протеїновий комплекс il-15, та її застосування
MX2020013953A (es) *	2018-07-11	2021-03-09	Takeda Pharmaceuticals Co	Composiciones de virus adenoasociado (aav).
EP4037704B1 (en)	2019-10-04	2025-12-03	The Children's Medical Center Corporation	Adamts13 treatment to enhance graft survival
WO2021198781A2 (en)	2020-04-02	2021-10-07	Takeda Pharmaceutical Company Limited	Adamts13 variant, compositions, and uses thereof
JP2023526546A (ja)	2020-05-22	2023-06-21	武田薬品工業株式会社	コロナウイルス疾患の合併症の治療及び診断のための、ａｄａｍｔｓ１３組成物及び方法
US20230295597A1 (en) *	2020-08-13	2023-09-21	Hadasit Medical Research Services & Development Limited	A disintegrin and metalloproteinase with a thrombospondin type i motif, member 13 (adamts-13) mutants, compositions and therapeutic methods thereof
CA3244889A1 (en)	2022-03-08	2023-09-14	Equashield Medical Ltd	FLUID TRANSFER STATION IN A ROBOTIC PHARMACEUTICAL PREPARATION SYSTEM
KR20240112755A (ko) *	2023-01-11	2024-07-19	주식회사 녹십자	혈전성 질환의 예방 또는 치료를 위한 신규한 액상 제형물

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AU2010295299B2 (en) *	2009-09-21	2015-12-24	Takeda Pharmaceutical Company Limited	Stabilized liquid and lyophilized ADAMTS13 formulations
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2010
- 2010-09-21 AU AU2010295299A patent/AU2010295299B2/en active Active
- 2010-09-21 MX MX2016005314A patent/MX362382B/es unknown
- 2010-09-21 HU HUE10759786A patent/HUE028688T2/en unknown
- 2010-09-21 EP EP23172759.5A patent/EP4218797B9/en active Active
- 2010-09-21 PL PL10759786.6T patent/PL2480198T3/pl unknown
- 2010-09-21 PL PL20211228.0T patent/PL3834841T3/pl unknown
- 2010-09-21 FI FIEP20211228.0T patent/FI3834841T3/fi active
- 2010-09-21 NZ NZ598839A patent/NZ598839A/en unknown
- 2010-09-21 WO PCT/US2010/049723 patent/WO2011035335A2/en not_active Ceased
- 2010-09-21 DK DK10759786.6T patent/DK2480198T3/da active
- 2010-09-21 ES ES23172759T patent/ES3001509T3/es active Active
- 2010-09-21 KR KR1020247043292A patent/KR20250008986A/ko active Pending
- 2010-09-21 EA EA201200519A patent/EA024267B1/ru not_active IP Right Cessation
- 2010-09-21 KR KR1020217013486A patent/KR20210054598A/ko not_active Ceased
- 2010-09-21 BR BR112012006283-2A patent/BR112012006283B1/pt active IP Right Grant
- 2010-09-21 IN IN2645DEN2012 patent/IN2012DN02645A/en unknown
- 2010-09-21 US US12/887,424 patent/US8623352B2/en active Active
- 2010-09-21 DK DK15203085.4T patent/DK3167897T3/da active
- 2010-09-21 EP EP24192531.2A patent/EP4467160A3/en active Pending
- 2010-09-21 EP EP15203085.4A patent/EP3167897B1/en active Active
- 2010-09-21 MX MX2012003414A patent/MX339205B/es active IP Right Grant
- 2010-09-21 KR KR1020227034508A patent/KR20220139456A/ko not_active Ceased
- 2010-09-21 FI FIEP23172759.5T patent/FI4218797T3/fi active
- 2010-09-21 CN CN201410452647.8A patent/CN104224705B/zh active Active
- 2010-09-21 PT PT231727595T patent/PT4218797T/pt unknown
- 2010-09-21 ES ES15203085T patent/ES2865250T3/es active Active
- 2010-09-21 EP EP10759786.6A patent/EP2480198B9/en active Active
- 2010-09-21 ES ES10759786.6T patent/ES2579906T3/es active Active
- 2010-09-21 KR KR1020197035791A patent/KR20190137954A/ko not_active Ceased
- 2010-09-21 CA CA2774556A patent/CA2774556A1/en not_active Abandoned
- 2010-09-21 HR HRP20160295TT patent/HRP20160295T1/hr unknown
- 2010-09-21 PL PL23172759.5T patent/PL4218797T3/pl unknown
- 2010-09-21 DK DK23172759.5T patent/DK4218797T5/da active
- 2010-09-21 KR KR1020187023806A patent/KR20180095738A/ko not_active Ceased
- 2010-09-21 ES ES20211228T patent/ES2948612T3/es active Active
- 2010-09-21 KR KR1020127009803A patent/KR101891646B1/ko active Active
- 2010-09-21 PT PT202112280T patent/PT3834841T/pt unknown
- 2010-09-21 PL PL15203085T patent/PL3167897T3/pl unknown
- 2010-09-21 EP EP20211228.0A patent/EP3834841B1/en active Active
- 2010-09-21 CN CN201080046707.6A patent/CN102573792B/zh active Active
- 2010-09-21 DK DK20211228.0T patent/DK3834841T3/da active
- 2010-09-21 JP JP2012529982A patent/JP5819303B2/ja active Active
2012
- 2012-03-21 MX MX2019000547A patent/MX2019000547A/es unknown
2013
- 2013-11-22 US US14/088,169 patent/US9351935B2/en active Active
2014
- 2014-12-24 JP JP2014259954A patent/JP2015063556A/ja active Pending
2016
- 2016-05-03 US US15/145,755 patent/US9572778B2/en active Active
2017
- 2017-01-06 US US15/400,526 patent/US9937244B2/en active Active
2018
- 2018-02-28 US US15/908,213 patent/US10238720B2/en active Active
2019
- 2019-02-14 US US16/275,690 patent/US10758599B2/en active Active
2020
- 2020-07-21 US US16/934,100 patent/US11564979B2/en active Active
2022
- 2022-12-23 US US18/146,212 patent/US12178861B2/en active Active
2024
- 2024-11-19 US US18/952,409 patent/US20250099559A1/en active Pending
- 2024-12-10 FR FR24C1049C patent/FR24C1049I2/fr active Active

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ES2948612T3 (es)	2023-09-14
CN104224705B (zh)	2018-02-02
FI3834841T3 (fi)	2023-06-05
US20250099559A1 (en)	2025-03-27
US20140178357A1 (en)	2014-06-26
CN102573792A (zh)	2012-07-11
KR20180095738A (ko)	2018-08-27
HUE028688T2 (en)	2017-01-30
FR24C1049I1 (fr)	2025-01-17
AU2010295299B2 (en)	2015-12-24
JP5819303B2 (ja)	2015-11-24
ES2579906T3 (es)	2016-08-17
HRP20160295T1 (hr)	2016-05-20
JP2013505270A (ja)	2013-02-14
PL3834841T3 (pl)	2023-07-24
FR24C1049I2 (fr)	2025-12-12
EP4218797A1 (en)	2023-08-02
MX362382B (es)	2019-01-14
MX2019000547A (es)	2020-11-12
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DK2480198T3 (da)	2016-03-29
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US9572778B2 (en)	2017-02-21
WO2011035335A3 (en)	2011-12-01
KR20210054598A (ko)	2021-05-13
DK3834841T3 (da)	2023-06-06
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PT4218797T (pt)	2024-12-09
CA2774556A1 (en)	2011-03-24
PL2480198T3 (pl)	2016-09-30
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HK1173968A1 (zh)	2013-05-31
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EP3834841B1 (en)	2023-05-17
US20160375111A1 (en)	2016-12-29
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KR20250008986A (ko)	2025-01-16
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BR112012006283A2 (pt)	2016-05-31
CN102573792B (zh)	2014-10-15
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US10758599B2 (en)	2020-09-01
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PL3167897T3 (pl)	2021-09-27
KR20120099646A (ko)	2012-09-11
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CN104224705A (zh)	2014-12-24
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ES3001509T3 (en)	2025-03-05
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NZ598839A (en)	2014-03-28
DK4218797T3 (da)	2024-12-09
EA024267B1 (ru)	2016-09-30
US20190247475A1 (en)	2019-08-15
US8623352B2 (en)	2014-01-07
KR20220139456A (ko)	2022-10-14
PT3834841T (pt)	2023-06-19
US20230130866A1 (en)	2023-04-27
FI4218797T3 (fi)	2024-12-07
IN2012DN02645A (da)	2015-09-11
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US20110229455A1 (en)	2011-09-22
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US9937244B2 (en)	2018-04-10
AU2010295299A1 (en)	2012-04-12
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EP4218797B9 (en)	2025-03-05

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