DK3033344T3 - Hemisulfatsalt af 5,10-methylen-(6r)-tetrahydrofolinsyre - Google Patents
Hemisulfatsalt af 5,10-methylen-(6r)-tetrahydrofolinsyre Download PDFInfo
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- DK3033344T3 DK3033344T3 DK14758102.9T DK14758102T DK3033344T3 DK 3033344 T3 DK3033344 T3 DK 3033344T3 DK 14758102 T DK14758102 T DK 14758102T DK 3033344 T3 DK3033344 T3 DK 3033344T3
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- Prior art keywords
- hemisulfate salt
- thf
- hemisulfate
- pharmaceutical composition
- expressed
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D487/00—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
- C07D487/12—Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00 in which the condensed system contains three hetero rings
- C07D487/14—Ortho-condensed systems
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- 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
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- 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
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- 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
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- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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
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- 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
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D475/00—Heterocyclic compounds containing pteridine ring systems
- C07D475/02—Heterocyclic compounds containing pteridine ring systems with an oxygen atom directly attached in position 4
- C07D475/04—Heterocyclic compounds containing pteridine ring systems with an oxygen atom directly attached in position 4 with a nitrogen atom directly attached in position 2
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D475/00—Heterocyclic compounds containing pteridine ring systems
- C07D475/12—Heterocyclic compounds containing pteridine ring systems containing pteridine ring systems condensed with carbocyclic rings or ring systems
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D475/00—Heterocyclic compounds containing pteridine ring systems
- C07D475/12—Heterocyclic compounds containing pteridine ring systems containing pteridine ring systems condensed with carbocyclic rings or ring systems
- C07D475/14—Benz [g] pteridines, e.g. riboflavin
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- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07B—GENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
- C07B2200/00—Indexing scheme relating to specific properties of organic compounds
- C07B2200/13—Crystalline forms, e.g. polymorphs
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- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Inorganic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Steroid Compounds (AREA)
Claims (17)
1. Hemisulfatsalt af 5,10-methylen-(6R)-tetrahydrofolinsyre.
2. Hemisulfatsalt if0lge krav 1 i i det veesentlige krystallinsk form.
3. Hemisulfatsalt ifolge kravene 1 eller 2 med mindst 80%, fortrinsvis 90%, fortrinsvis 95%, mere fortrinsvis 97%, mest fortrinsvis 99% eller derover krystallinsk renhed.
4. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav med mindst 80%, fortrinsvis 90%, fortrinsvis 95%, mere fortrinsvis 97%, mest fortrinsvis 99% eller derover kemisk renhed.
5. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav i vandfri form.
6. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav men én eller flere rontgen-monster-toppositioner ved en diffraktionsvinkel 2 theta pa 4,7°, 17,9°, og 23,3° udtrykt i 2Θ ±0,2° 2Θ (CuKa-straling, reflektion).
7. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav men én eller flere rontgen-monster-toppositioner ved en diffraktionsvinkel 2 theta pa 4,7°, 16,6°, 17,9°, 18,4°, 18,9°, 20,2°, 23,3°, 23,5°, 24,3°og 24,7° udtrykt i 2Θ ±0,2° 2Θ (CuKa-straling, reflektion).
8. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav med et FT-Raman-spektrum indeholdende én eller flere toppe ved bolgenumre (udtrykt i ±2 cnr1) pa 1672, 1656, 1603, 1553, 1474, 1301, 637, 624 og 363.
9. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav med et FT-Raman-spektrum i det vaesentlige i overensstemmelse med figur 1 og/eller med et rontgenpulverd¡ffraktions-(XRPD)-monster i det vaesentlige I overensstemmelse med figur 2(a) eller 2(b).
10. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav med mindst 2 af folgende 10 XRPD-toppe (udtrykt i 2Θ ±0,2° 2Θ (CuKa-straling)) ved 4,7°, 16,6°, 17,9°, 18,4°, 18,9°, 20,2°, 23,3°, 23,5°, 24,3°og 24,7° og ved mindst 2 af folgende 9 FT-Raman-toppe (udtrykt i ±2 cm1) pa 1672, 1656, 1603, 1553, 1474, 1301, 637, 624 og 363.
11. Hemisulfatsalt ifolge et hvilket som helst af de foregaende krav med mindst 2 af folgende 3 XRPD-toppe (udtrykt i 2Θ ±0,2° 2Θ (CuKa-straling)) ved 4,7°, 17,9°, og 23,3° og ved mindst 2 af folgende 5 FT-Raman-toppe (udtrykt i ±2 cm1) pa 1672, 1656, 1603, 1553, 1474, 1301, 637, 624 og 363.
12. Farmaceutisk sammensaetning omfattende et hemisulfatsalt af 5,10-methylen-(6R)-tetrahydrofolinsyre ifolge et hvilket som helst af de foregaende krav og eventuelt en farmaceutisk acceptabel baerer.
13. Farmaceutisk sammensaetning ifolge krav 12 i form af tabletter, kapsler, oralt flydende preeparater, pulvere, lyofilisater, granulater, pastiller, genoploselige pulvere, injicerbare eller infunderbare oplosninger eller suspensioner eller suppositorier, fortrinsvis lyofilisater.
14. Farmaceutisk sammensaetning ifolge kravene 12 eller 13 yderligere omfattende mindst et yderligere terapeutisk middel.
15. Farmaceutisk sammensaetning ifolge et hvilket som helst af kravene 12 til 14, der er en farmaceutisk sammensaetning til oral, parenteral eller rektal administration.
16. Hemisulfatsalt af 5,10-methylen-(6R)-tetrahydrofolinsyre ifolge et hvilket som helst af kravene 1 til 11 eller en farmaceutisk sammensaetning ifolge et hvilket som helst af kravene 12 til 15 til anvendelse i terapi, fortrinsvis cancerkemoterapi.
17. Forbindelse ifolge kravene 1 til 11 til anvendelse i en fremgangsmade til behandling af cáncer omfattende administration af et hemisulfatsalt af 5,10-methylen-(6R)-tetrahydrofolinsyre ifolge et hvilket som helst af kravene 1 til 11 eller en farmaceutisk sammensaetning ifolge et hvilket som helst af kravene 12 til 15 til et individ med behov for en sadan behandling.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP13004050.4A EP2837631A1 (en) | 2013-08-14 | 2013-08-14 | New stable salt of 5,10-methylene-(6R)-tetrahydrofolic acid |
PCT/EP2014/067447 WO2015022407A1 (en) | 2013-08-14 | 2014-08-14 | Hemisulfate salt of 5,10-methylene-(6r)-tetrahydrofolic acid |
Publications (1)
Publication Number | Publication Date |
---|---|
DK3033344T3 true DK3033344T3 (da) | 2017-12-18 |
Family
ID=48998397
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK17190279.4T DK3287460T3 (da) | 2013-08-14 | 2014-08-14 | Hemisulfatsalt af 5,10-methylen-(6r)-tetrahydrofolsyre |
DK14758102.9T DK3033344T3 (da) | 2013-08-14 | 2014-08-14 | Hemisulfatsalt af 5,10-methylen-(6r)-tetrahydrofolinsyre |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK17190279.4T DK3287460T3 (da) | 2013-08-14 | 2014-08-14 | Hemisulfatsalt af 5,10-methylen-(6r)-tetrahydrofolsyre |
Country Status (27)
Country | Link |
---|---|
US (3) | US20160185787A1 (da) |
EP (3) | EP2837631A1 (da) |
JP (5) | JP6617104B2 (da) |
KR (2) | KR102439605B1 (da) |
CN (2) | CN105452250B (da) |
AU (2) | AU2014307872B2 (da) |
BR (2) | BR112016002770B1 (da) |
CA (1) | CA2921178C (da) |
CY (2) | CY1119694T1 (da) |
DK (2) | DK3287460T3 (da) |
EA (3) | EA202091271A3 (da) |
ES (2) | ES2654474T3 (da) |
HK (2) | HK1217018A1 (da) |
HR (2) | HRP20171895T1 (da) |
HU (2) | HUE054504T2 (da) |
IL (2) | IL244069B (da) |
LT (2) | LT3287460T (da) |
MX (1) | MX360355B (da) |
NO (1) | NO3033344T3 (da) |
NZ (2) | NZ717825A (da) |
PL (2) | PL3287460T3 (da) |
PT (2) | PT3033344T (da) |
RS (2) | RS56910B1 (da) |
SG (2) | SG10201801179VA (da) |
SI (2) | SI3033344T1 (da) |
WO (1) | WO2015022407A1 (da) |
ZA (1) | ZA201509204B (da) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2837631A1 (en) * | 2013-08-14 | 2015-02-18 | Merck & Cie | New stable salt of 5,10-methylene-(6R)-tetrahydrofolic acid |
US10059710B2 (en) | 2016-02-17 | 2018-08-28 | Merck & Cie | Stable formulations of 5,10-methylene-(6R)-tetrahydrofolic acid |
EP3446704A1 (en) * | 2017-08-24 | 2019-02-27 | Isofol Medical AB | [6r]-mthf - an efficient folate alternative in 5-fluorouracil based chemotherapy |
EP3446703A1 (en) * | 2017-08-24 | 2019-02-27 | Isofol Medical AB | 6r]-mthf multiple bolus administration in 5-fluorouracil based chemotherapy |
JP7232815B2 (ja) * | 2017-08-16 | 2023-03-03 | メルク パテント ゲゼルシャフト ミット ベシュレンクテル ハフツング | 5,10-メチレン-(6r)-テトラヒドロ葉酸を含む安定な凍結乾燥物 |
AU2019205861A1 (en) * | 2018-01-05 | 2020-08-06 | Isofol Medical Ab | Methods for treating colorectal and metastatic colorectal cancers |
KR20220152385A (ko) * | 2020-03-30 | 2022-11-15 | 수미토모 케미칼 컴퍼니 리미티드 | 적층체 |
WO2023237483A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Concentrated solutions comprising 5,10-methylene-(6r)-tetrahydrofolic acid |
WO2023237485A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Stable lyophilisates comprising 5,10-methylene-(6r)-tetrahydrofolic acid |
WO2023237480A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Stable pharmaceutical compositions comprising 5,10-methylene-(6r)-tetrahydrofolic acid and nacl |
WO2023237482A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Concentrated solutions comprising sodium 5,10-methylene-(6r)- tetrahydrofolate |
WO2023237484A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Compositions comprising disodium 5,10-methylene-(6r)-tetrahydrofolate |
Family Cites Families (15)
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US2300505A (en) * | 1940-10-31 | 1942-11-03 | Bell Telephone Labor Inc | Selective system |
ATE57612T1 (de) | 1983-05-20 | 1990-11-15 | Bengt Gustavsson | Anordnung zur uebertragung einer substanz. |
DE3821875C1 (da) * | 1988-06-29 | 1990-02-15 | Eprova Ag, Forschungsinstitut, Schaffhausen, Ch | |
CH682664A5 (en) * | 1991-10-15 | 1993-10-29 | Eprova Ag | Stable salts of 5,10-methylene tetrahydrofolate. |
CH684644A5 (de) | 1992-07-13 | 1994-11-15 | Eprova Ag | 5,10-Methylentetrahydrofolsäure-Cyclodextrin-Einschlussverbindungen. |
HU226998B1 (en) * | 2000-11-23 | 2010-04-28 | Richter Gedeon Nyrt | Desloratadine hemisulphate, process for the preparation thereof and pharmaceutical compositions containing the same |
CH696628A5 (de) * | 2002-02-26 | 2007-08-31 | Eprova Ag | Verwendung von Folaten zur Herstellung einer Zubereitung geeignet zur Vorbeugung und Behandlung von Entzündungen und entzündungsassoziierter Krankheiten, im Speziellen zur Beeinflussung der |
CH697021A5 (de) * | 2003-06-26 | 2008-03-31 | Merck Eprova Ag | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
CA2631755A1 (en) * | 2005-12-02 | 2007-06-07 | Adventrx Pharmaceuticals, Inc. | Stable pharmaceutical compositions of 5,10 methylenetetrahydrofolate |
AU2007336369B2 (en) * | 2006-12-21 | 2013-01-17 | F. Hoffmann-La Roche Ag | Polymorphs of a mGluR5 receptor antagonist |
JP5294968B2 (ja) | 2009-05-01 | 2013-09-18 | 三星ダイヤモンド工業株式会社 | スクライブヘッド及び該スクライブヘッドを用いたスクライブ装置 |
JP6069336B2 (ja) * | 2011-10-19 | 2017-02-01 | マーケイター メドシステムズ, インコーポレイテッド | 腎の脱神経を包含する治療効果を増強するための組織および細胞の局所的調節 |
EP2837631A1 (en) * | 2013-08-14 | 2015-02-18 | Merck & Cie | New stable salt of 5,10-methylene-(6R)-tetrahydrofolic acid |
EP2837766A1 (de) * | 2013-08-14 | 2015-02-18 | Sika Technology AG | Verfahren zum Ausfüllen einer Fuge mit einem Kleb- und/oder Dichtstoff sowie System zum Ausfüllen einer Fuge mit einem Kleb- und/oder Dichtstoff |
JP6971761B2 (ja) * | 2017-10-11 | 2021-11-24 | 株式会社Ihiプラント | タンクの構築方法 |
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2013
- 2013-08-14 EP EP13004050.4A patent/EP2837631A1/en not_active Withdrawn
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2014
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- 2014-08-14 BR BR122020002802-5A patent/BR122020002802B1/pt active IP Right Grant
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- 2014-08-14 CN CN201480044477.8A patent/CN105452250B/zh active Active
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- 2014-08-14 EA EA201600172A patent/EA032179B1/ru not_active IP Right Cessation
- 2014-08-14 US US14/912,328 patent/US20160185787A1/en not_active Abandoned
- 2014-08-14 EA EA201892729A patent/EA201892729A1/ru unknown
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- 2014-08-14 NO NO14758102A patent/NO3033344T3/no unknown
- 2014-08-14 CN CN201810160334.3A patent/CN108096200A/zh active Pending
- 2014-08-14 JP JP2016533926A patent/JP6617104B2/ja active Active
- 2014-08-14 NZ NZ745811A patent/NZ745811A/en unknown
- 2014-08-14 RS RS20210630A patent/RS61986B1/sr unknown
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- 2016-04-29 HK HK16104972.6A patent/HK1217018A1/zh unknown
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2018
- 2018-09-03 JP JP2018164332A patent/JP6735321B2/ja active Active
- 2018-11-29 HK HK18115320.9A patent/HK1256262A1/zh unknown
- 2018-12-06 US US16/212,056 patent/US20190106431A1/en not_active Abandoned
- 2018-12-13 AU AU2018278943A patent/AU2018278943B2/en active Active
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- 2021-10-08 US US17/496,939 patent/US20220024940A1/en active Pending
- 2021-11-11 JP JP2021183793A patent/JP2022024035A/ja active Pending
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