DK2706982T3 - Intranasale farmaceutiske dosisformer omfattende naloxon - Google Patents
Intranasale farmaceutiske dosisformer omfattende naloxon Download PDFInfo
- Publication number
- DK2706982T3 DK2706982T3 DK12721507.7T DK12721507T DK2706982T3 DK 2706982 T3 DK2706982 T3 DK 2706982T3 DK 12721507 T DK12721507 T DK 12721507T DK 2706982 T3 DK2706982 T3 DK 2706982T3
- Authority
- DK
- Denmark
- Prior art keywords
- naloxone
- dosage form
- administration
- amount
- nostril
- Prior art date
Links
Classifications
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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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- 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
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0043—Nose
-
- 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
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory 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
-
- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/36—Opioid-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Emergency Medicine (AREA)
- Otolaryngology (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Dispersion Chemistry (AREA)
- Addiction (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Pulmonology (AREA)
- Pain & Pain Management (AREA)
- Psychiatry (AREA)
- Toxicology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Claims (14)
1. Intranasal farmaceutisk dosisform omfattende en doseringsenhed omfattende naloxon eller et farmaceutisk acceptabelt salt deraf i en mængde svarende til mellem 0,65 mg naloxon HCI og 0,8 mg naloxon HCI eller mellem 1,3 mg naloxon HCI og 1,6 mg naloxon HCI opløst i en applikationsfluid i et volumen på < 250 pi, fortrinsvis < 200 μΙ.
2. Dosisform ifølge krav 1, hvor volumenet af applikationsfluiden er inden for et område på 200 μΙ til 35 μΙ, fortrinsvis på 200 μΙ til 50 μΙ, mere fortrinsvis på 200 μΙ til 100 μΙ.
3. Dosisform ifølge krav 1 eller 2, hvor applikationsfluiden er valgt fra gruppen omfattende vand og en vandig saltopløsning, fortrinsvis en vandig NaCI-opløsning, mere fortrinsvis en vandig 0,9 % (vægt/volumen) NaCI-opløsning.
4. Dosisform ifølge et hvilket som helst af de foregående krav, hvor dosisformen er valgt fra gruppen af dosisformer omfattende en næsespray, en nasal slimhindeklæbende dosisform og en slimhinde-forstøvningsindretning (Mucosal Atomizer Device).
5. Intranasal farmaceutisk dosisform omfattende naloxon eller et farmaceutisk acceptabelt salt deraf opløst i en applikationsfluid til anvendelse i behandlingen af mindst et af opioid overdoserings-associerede symptomer af åndenød, ændret bevidsthedsniveau, miotiske pupiller, hypoxæmi, akut lungeskade og aspirationslungebetændelse, hvor en mængde svarende til mellem 1,3 mg naloxon HCI og 1,6 mg naloxon HCI administreres intranasalt, hvor mængden tilvejebringes ved administration til et næsebor eller hvor mængden er tilvejebragt ved administration til to næsebor, og hvor volumenet af applikationsfluiden per næsebor er < 250 μΙ, fortrinsvis < 200 μΙ.
6. Dosisform til anvendelse ifølge krav 5, hvor en mængde af naloxon eller et farmaceutisk acceptabelt salt deraf svarende til 1,3 mg naloxon HCI eller 1,4 mg naloxon HCI eller 1,5 mg naloxon HCI eller 1,6 mg naloxon HCI administreres intranasalt.
7. Dosisform til anvendelse ifølge krav 5 eller 6, hvor volumenet af applikationsfluiden per næsebor er inden for et område på 200 pi til 35 μΙ, fortrinsvis på 200 μΙ til 50 μΙ, mere fortrinsvis på 200 μΙ til 100 μΙ.
8. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 7, hvor volumenet af applikationsfluiden per næsebor er inden for et område på 150 μΙ til 100 μΙ.
9. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 8, hvor mængden tilvejebringes ved administration til et næsebor.
10. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 9, hvor applikationsfluiden er valgt fra gruppen omfattende vand og en vandig saltopløsning, fortrinsvis en vandig NaCI-opløsning, mere fortrinsvis en vandig 0,9 % (vægt/volumen) NaCI-opløsning.
11. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 10, hvor dosisformen omfatter mængden eller halvdelen af mængden opløst i en applikationsfluid i en doseringsenhed, hvor mængden er afhængig af hvorvidt mængden tilvejebringes ved administration til et næsebor eller ved administration til to næsebor.
12. Dosisform til anvendelse ifølge krav 11, hvor dosisformen omfatter en enkelt doseringsenhed eller to doseringsenheder, afhængigt af hvorvidt mængden tilvejebringes ved administration til et næsebor eller ved administration til to næsebor, og er til enkelt anvendelse eller hvor dosisformen omfatter mindst to doseringsenheder, fortrinsvis mindst tre doseringsenheder, mere fortrinsvis mindst fire doseringsenheder og most fortrinsvis mindst fem doseringsenheder og er til multiple anvendelser.
13. Dosisform til anvendelse ifølge et hvilket som helst af kravene 5 til 12, hvor dosisformen er valgt fra gruppen af dosisformer omfattende en næsespray, en nasal slimhindeklæbende dosisform og en slimhinde-forstøvningsindretning (Mucosal Atomizer Device).
14. Dosisform til anvendelse ifølge krav 5, hvor åndenøden er postoperativ opioid åndenød.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11166076 | 2011-05-13 | ||
PCT/EP2012/058792 WO2012156317A2 (en) | 2011-05-13 | 2012-05-11 | Intranasal pharmaceutical dosage forms comprising naloxone |
Publications (2)
Publication Number | Publication Date |
---|---|
DK2706982T3 true DK2706982T3 (da) | 2018-03-12 |
DK2706982T4 DK2706982T4 (da) | 2021-05-10 |
Family
ID=44658496
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DK12721507.7T DK2706982T4 (da) | 2011-05-13 | 2012-05-11 | Intranasale farmaceutiske dosisformer omfattende naloxon |
DKBA201800034U DK201800034U1 (da) | 2011-05-13 | 2018-04-19 | Intranasale farmaceutiske doseringsformer, der omfatter naloxon |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DKBA201800034U DK201800034U1 (da) | 2011-05-13 | 2018-04-19 | Intranasale farmaceutiske doseringsformer, der omfatter naloxon |
Country Status (36)
Country | Link |
---|---|
US (7) | US20150018379A1 (da) |
EP (2) | EP3320893A1 (da) |
JP (3) | JP6110367B2 (da) |
KR (2) | KR101698182B1 (da) |
CN (2) | CN107260672A (da) |
AR (1) | AR086391A1 (da) |
AT (1) | AT16553U1 (da) |
AU (2) | AU2012257785B2 (da) |
BR (1) | BR112013029126A2 (da) |
CA (1) | CA2835940C (da) |
CO (1) | CO6821959A2 (da) |
CY (1) | CY1120399T1 (da) |
DE (1) | DE202012013606U1 (da) |
DK (2) | DK2706982T4 (da) |
ES (1) | ES2661838T5 (da) |
HK (1) | HK1255428A1 (da) |
HR (1) | HRP20180233T1 (da) |
HU (1) | HUE036465T2 (da) |
IL (1) | IL229409B (da) |
LT (1) | LT2706982T (da) |
ME (1) | ME02958B (da) |
MX (1) | MX354249B (da) |
MY (1) | MY194947A (da) |
NO (1) | NO2706982T3 (da) |
PH (1) | PH12016501342B1 (da) |
PL (1) | PL2706982T3 (da) |
PT (1) | PT2706982T (da) |
RS (1) | RS57054B1 (da) |
RU (2) | RU2657441C1 (da) |
SG (1) | SG194927A1 (da) |
SI (1) | SI2706982T1 (da) |
TR (1) | TR201802716T4 (da) |
TW (1) | TWI486161B (da) |
UA (1) | UA110974C2 (da) |
WO (1) | WO2012156317A2 (da) |
ZA (1) | ZA201308280B (da) |
Families Citing this family (24)
Publication number | Priority date | Publication date | Assignee | Title |
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US8939943B2 (en) | 2011-01-26 | 2015-01-27 | Kaleo, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
US8627816B2 (en) | 2011-02-28 | 2014-01-14 | Intelliject, Inc. | Medicament delivery device for administration of opioid antagonists including formulations for naloxone |
ME02958B (me) * | 2011-05-13 | 2018-07-20 | Euro Celtique Sa | Intranazalni farmaceutski dozni oblici коji obuhvataju nalokson |
CA2875384A1 (en) * | 2013-12-20 | 2015-06-20 | AntiOP, Inc. | Intranasal naloxone compositions and methods of making and using same |
US9561177B2 (en) | 2014-03-14 | 2017-02-07 | Adapt Pharma Limited | Nasal drug products and methods of their use |
US9480644B2 (en) | 2014-03-14 | 2016-11-01 | Opiant Pharmaceuticals, Inc. | Nasal drug products and methods of their use |
US10085937B2 (en) | 2014-03-14 | 2018-10-02 | Adapt Pharma Limited | Nasal drug products and methods of their use |
CA2942611C (en) | 2014-03-14 | 2017-10-10 | Opiant Pharmaceuticals, Inc. | Nasal naloxone compositions and devices |
US11135155B2 (en) * | 2014-07-08 | 2021-10-05 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
US10722510B2 (en) | 2014-07-08 | 2020-07-28 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
CA2954637A1 (en) * | 2014-07-09 | 2016-01-14 | Opiant Pharmaceuticals, Inc. | Co-packaged drug products |
US9517307B2 (en) | 2014-07-18 | 2016-12-13 | Kaleo, Inc. | Devices and methods for delivering opioid antagonists including formulations for naloxone |
US11559483B2 (en) * | 2015-07-10 | 2023-01-24 | Sanjay Gupta | Nasal foam via cribriform plate for medication delivery to the brain and/or body and for nasal moisturization and hygiene |
WO2017049181A1 (en) * | 2015-09-17 | 2017-03-23 | Adapt Pharma Limited | Nasal drug products and methods of their use |
WO2017223566A1 (en) * | 2016-06-24 | 2017-12-28 | Opiant Pharmaceuticals, Inc. | Compositions, devices, and methods for the treatment of alcohol use disorder |
MA45995A (fr) * | 2016-08-17 | 2019-06-26 | Insys Dev Co Inc | Pulvérisation de naloxone liquide |
WO2020198327A1 (en) * | 2019-03-26 | 2020-10-01 | Pocket Naloxone Corp. | Devices and methods for delivering pharmaceutical compositions |
EP3946547A4 (en) * | 2019-03-26 | 2023-01-18 | Pocket Naloxone Corp. | DEVICES AND METHODS FOR DELIVERING PHARMACEUTICAL COMPOSITIONS |
US10653690B1 (en) | 2019-07-09 | 2020-05-19 | Orexo Ab | Pharmaceutical composition for nasal delivery |
US10729687B1 (en) | 2019-07-09 | 2020-08-04 | Orexo Ab | Pharmaceutical composition for nasal delivery |
US20230201369A1 (en) * | 2020-04-29 | 2023-06-29 | The Texas A&M University System | Naloxone nanoparticle compositions and methods thereof |
SI3962455T1 (sl) | 2020-05-18 | 2022-11-30 | Orexo Ab | Nov farmacevtski sestavek za dostavo zdravil |
US11278709B1 (en) | 2021-03-12 | 2022-03-22 | Pocket Naloxone Corp. | Drug delivery device and methods for using same |
WO2023094826A1 (en) | 2021-11-25 | 2023-06-01 | Orexo Ab | Pharmaceutical composition comprising adrenaline |
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US4464378A (en) * | 1981-04-28 | 1984-08-07 | University Of Kentucky Research Foundation | Method of administering narcotic antagonists and analgesics and novel dosage forms containing same |
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US5866154A (en) * | 1994-10-07 | 1999-02-02 | The Dupont Merck Pharmaceutical Company | Stabilized naloxone formulations |
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GB9908921D0 (en) * | 1999-04-19 | 1999-06-16 | Britannia Pharmaceuticals Ltd | Spray dispenser for opiod antagonists |
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SG161208A1 (en) * | 2004-12-23 | 2010-05-27 | Roxro Pharma Inc | Therapeutic compositions for intranasal administration of ketorolac |
US8911751B2 (en) | 2005-10-11 | 2014-12-16 | Yissum Research Development Company Of The Hebrew University Of Jerusalem | Compositions for nasal delivery |
US20070212307A1 (en) * | 2006-02-10 | 2007-09-13 | Daniel Wermeling | Pharmaceutical Compositions Comprising an Opioid Receptor Antagonist and Methods of Using Same |
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ME02958B (me) * | 2011-05-13 | 2018-07-20 | Euro Celtique Sa | Intranazalni farmaceutski dozni oblici коji obuhvataju nalokson |
CA2875384A1 (en) | 2013-12-20 | 2015-06-20 | AntiOP, Inc. | Intranasal naloxone compositions and methods of making and using same |
US9561177B2 (en) | 2014-03-14 | 2017-02-07 | Adapt Pharma Limited | Nasal drug products and methods of their use |
CA2942611C (en) | 2014-03-14 | 2017-10-10 | Opiant Pharmaceuticals, Inc. | Nasal naloxone compositions and devices |
US10085937B2 (en) | 2014-03-14 | 2018-10-02 | Adapt Pharma Limited | Nasal drug products and methods of their use |
US9480644B2 (en) | 2014-03-14 | 2016-11-01 | Opiant Pharmaceuticals, Inc. | Nasal drug products and methods of their use |
US10617686B2 (en) | 2014-07-08 | 2020-04-14 | Hikma Pharmaceuticals Usa Inc. | Liquid naloxone spray |
-
2012
- 2012-05-11 ME MEP-2018-35A patent/ME02958B/me unknown
- 2012-05-11 US US14/084,551 patent/US20150018379A1/en not_active Abandoned
- 2012-05-11 LT LTEP12721507.7T patent/LT2706982T/lt unknown
- 2012-05-11 DK DK12721507.7T patent/DK2706982T4/da active
- 2012-05-11 WO PCT/EP2012/058792 patent/WO2012156317A2/en active Application Filing
- 2012-05-11 AU AU2012257785A patent/AU2012257785B2/en active Active
- 2012-05-11 CA CA2835940A patent/CA2835940C/en active Active
- 2012-05-11 BR BR112013029126A patent/BR112013029126A2/pt not_active IP Right Cessation
- 2012-05-11 KR KR1020137032730A patent/KR101698182B1/ko active IP Right Grant
- 2012-05-11 CN CN201710310253.2A patent/CN107260672A/zh active Pending
- 2012-05-11 RS RS20180193A patent/RS57054B1/sr unknown
- 2012-05-11 HU HUE12721507A patent/HUE036465T2/hu unknown
- 2012-05-11 AT ATGM50043/2018U patent/AT16553U1/de not_active IP Right Cessation
- 2012-05-11 TW TW101116857A patent/TWI486161B/zh not_active IP Right Cessation
- 2012-05-11 DE DE202012013606.2U patent/DE202012013606U1/de not_active Expired - Lifetime
- 2012-05-11 JP JP2014509762A patent/JP6110367B2/ja active Active
- 2012-05-11 NO NO12721507A patent/NO2706982T3/no unknown
- 2012-05-11 CN CN201280032034.8A patent/CN103764119A/zh not_active Withdrawn
- 2012-05-11 PT PT127215077T patent/PT2706982T/pt unknown
- 2012-05-11 PL PL12721507T patent/PL2706982T3/pl unknown
- 2012-05-11 RU RU2016117731A patent/RU2657441C1/ru active
- 2012-05-11 EP EP17208976.5A patent/EP3320893A1/en not_active Withdrawn
- 2012-05-11 AR ARP120101700A patent/AR086391A1/es unknown
- 2012-05-11 EP EP12721507.7A patent/EP2706982B2/en active Active
- 2012-05-11 ES ES12721507T patent/ES2661838T5/es active Active
- 2012-05-11 SI SI201231239T patent/SI2706982T1/en unknown
- 2012-05-11 RU RU2013155479/15A patent/RU2587051C2/ru not_active IP Right Cessation
- 2012-05-11 MY MYPI2018001495A patent/MY194947A/en unknown
- 2012-05-11 SG SG2013083886A patent/SG194927A1/en unknown
- 2012-05-11 KR KR1020177001202A patent/KR101873174B1/ko active IP Right Grant
- 2012-05-11 MX MX2013013276A patent/MX354249B/es active IP Right Grant
- 2012-05-11 TR TR2018/02716T patent/TR201802716T4/tr unknown
- 2012-11-05 UA UAA201314634A patent/UA110974C2/uk unknown
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2013
- 2013-11-05 ZA ZA2013/08280A patent/ZA201308280B/en unknown
- 2013-11-12 IL IL229409A patent/IL229409B/en active IP Right Grant
- 2013-12-13 CO CO13291649A patent/CO6821959A2/es not_active Application Discontinuation
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2015
- 2015-01-06 US US14/590,808 patent/US20150126540A1/en not_active Abandoned
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2016
- 2016-01-14 JP JP2016005172A patent/JP2016128453A/ja active Pending
- 2016-07-05 PH PH12016501342A patent/PH12016501342B1/en unknown
- 2016-07-13 AU AU2016204880A patent/AU2016204880B2/en active Active
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2017
- 2017-01-27 US US15/418,138 patent/US20170231904A1/en not_active Abandoned
- 2017-05-09 US US15/590,466 patent/US20170304192A1/en not_active Abandoned
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2018
- 2018-02-07 HR HRP20180233TT patent/HRP20180233T1/hr unknown
- 2018-02-26 CY CY20181100228T patent/CY1120399T1/el unknown
- 2018-04-19 DK DKBA201800034U patent/DK201800034U1/da not_active Application Discontinuation
- 2018-05-09 JP JP2018090275A patent/JP2018150336A/ja active Pending
- 2018-11-15 HK HK18114591.4A patent/HK1255428A1/zh unknown
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2019
- 2019-08-23 US US16/549,838 patent/US11020343B2/en active Active
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2021
- 2021-04-23 US US17/238,509 patent/US11806428B2/en active Active
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2023
- 2023-09-19 US US18/370,116 patent/US20240082149A1/en active Pending
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