BR112014030820B1 - Composição aquosa, dispositivo de administração e seringa pré- carregada contendo uma formulação de anticorpo - Google Patents
Composição aquosa, dispositivo de administração e seringa pré- carregada contendo uma formulação de anticorpo Download PDFInfo
- Publication number
- BR112014030820B1 BR112014030820B1 BR112014030820-9A BR112014030820A BR112014030820B1 BR 112014030820 B1 BR112014030820 B1 BR 112014030820B1 BR 112014030820 A BR112014030820 A BR 112014030820A BR 112014030820 B1 BR112014030820 B1 BR 112014030820B1
- Authority
- BR
- Brazil
- Prior art keywords
- antibody
- baffr
- formulations
- antibodies
- mor6654b
- Prior art date
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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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
-
- 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
- A61K47/26—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
- A61K9/0012—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2878—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
-
- 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
- A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
- C07K2317/41—Glycosylation, sialylation, or fucosylation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
- C07K2317/565—Complementarity determining region [CDR]
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
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)
- Immunology (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Endocrinology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261658472P | 2012-06-12 | 2012-06-12 | |
| US61/658,472 | 2012-06-12 | ||
| PCT/IB2013/054777 WO2013186700A1 (en) | 2012-06-12 | 2013-06-11 | Antibody formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112014030820A2 BR112014030820A2 (pt) | 2017-07-25 |
| BR112014030820B1 true BR112014030820B1 (pt) | 2023-02-07 |
Family
ID=48914378
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112014030820-9A BR112014030820B1 (pt) | 2012-06-12 | 2013-06-11 | Composição aquosa, dispositivo de administração e seringa pré- carregada contendo uma formulação de anticorpo |
Country Status (36)
Families Citing this family (53)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SMT201800552T1 (it) | 2010-01-06 | 2018-11-09 | Dyax Corp | Proteine che legano la callicreina plasmatica |
| WO2012076670A2 (en) * | 2010-12-10 | 2012-06-14 | Novartis Ag | Antibody formulation |
| KR102320178B1 (ko) | 2011-01-06 | 2021-11-02 | 다케다 파머수티컬 컴패니 리미티드 | 혈장 칼리크레인 결합 단백질 |
| US9216219B2 (en) * | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
| TWI595007B (zh) | 2012-09-10 | 2017-08-11 | Neotope Biosciences Ltd | 抗ｍｃａｍ抗體及相關使用方法 |
| AU2014240045A1 (en) | 2013-03-15 | 2015-09-10 | Dyax Corp. | Anti-plasma kallikrein antibodies |
| US10513555B2 (en) * | 2013-07-04 | 2019-12-24 | Prothena Biosciences Limited | Antibody formulations and methods |
| CA2926089C (en) | 2013-10-24 | 2022-08-30 | Medimmune, Llc | Stable, aqueous antibody formulations |
| CN104730237A (zh) * | 2013-12-23 | 2015-06-24 | 国家纳米科学中心 | 试纸及其应用以及检测甲胎蛋白抗原、乙肝表面抗原或HIV的gp41抗体的方法 |
| EA038532B1 (ru) | 2014-01-21 | 2021-09-10 | Такеда Фармасьютикал Компани Лимитед | Способ лечения наследственного ангионевротического отека (hae) |
| PT3116911T (pt) | 2014-03-12 | 2019-09-04 | Prothena Biosciences Ltd | Anticorpos anti-mcam e métodos de utilização associados |
| JP2017514458A (ja) | 2014-03-12 | 2017-06-08 | プロセナ バイオサイエンシーズ リミテッド | Ｌｇ４−５に対して特異的な抗−ラミニン４抗体 |
| US10428158B2 (en) | 2014-03-27 | 2019-10-01 | Dyax Corp. | Compositions and methods for treatment of diabetic macular edema |
| KR101597037B1 (ko) | 2014-06-26 | 2016-02-24 | 엘지디스플레이 주식회사 | 구동소자의 전기적 특성 편차를 보상할 수 있는 유기발광 표시장치 |
| TWI806150B (zh) | 2014-11-07 | 2023-06-21 | 瑞士商諾華公司 | 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物 |
| US10464999B2 (en) | 2015-01-28 | 2019-11-05 | Prothena Biosciences Limited | Anti-transthyretin antibodies |
| KR102607829B1 (ko) * | 2015-03-30 | 2023-12-01 | 다케다 파머수티컬 컴패니 리미티드 | 혈장 칼리크레인 저해제 및 유전성 혈관부종 발작을 예방하기 위한 이의 용도 |
| EP3350226A2 (en) * | 2015-09-16 | 2018-07-25 | Prothena Biosciences Limited | Use of anti-mcam antibodies for treatment or prophylaxis of giant cell arteritis, polymyalgia rheumatica or takayasu's arteritis |
| LT3386541T (lt) * | 2015-12-07 | 2020-10-26 | Merck Patent Gmbh | Vandeninė farmacinė kompozicija, apimanti anti-pd-1 antikūną avelumabą |
| EP3387018A1 (en) | 2015-12-11 | 2018-10-17 | Dyax Corp. | Plasma kallikrein inhibitors and uses thereof for treating hereditary angioedema attack |
| SG10202012778YA (en) * | 2015-12-18 | 2021-01-28 | Astellas Pharma Inc | Pharmaceutical composition comprising anti-human tslp receptor antibody |
| MA45381A (fr) * | 2016-06-16 | 2021-04-21 | Janssen Vaccines & Prevention Bv | Formulation de vaccin contre le vih |
| CN110177805B (zh) | 2016-10-19 | 2024-04-02 | 英温拉公司 | 抗体构建体 |
| AU2017383142A1 (en) | 2016-12-22 | 2019-07-04 | Università Degli Studi Magna Graecia Catanzaro | A monoclonal antibody targeting a unique sialoglycosilated cancer-associated epitope of CD43 |
| BR112019018022A2 (pt) * | 2017-03-01 | 2020-06-02 | Medimmune Limited | Formulações de anticorpos monoclonais |
| BR112019018401A2 (pt) * | 2017-03-06 | 2020-04-07 | Merck Patent Gmbh | formulação aquosa de anticorpo anti-pd-l1 |
| US11639391B2 (en) * | 2017-04-18 | 2023-05-02 | Dr. Reddy's Laboratories Limited | Stable liquid pharmaceutical composition |
| JOP20190260A1 (ar) * | 2017-05-02 | 2019-10-31 | Merck Sharp & Dohme | صيغ ثابتة لأجسام مضادة لمستقبل الموت المبرمج 1 (pd-1) وطرق استخدامها |
| DK3658184T5 (da) * | 2017-07-27 | 2024-08-26 | Alexion Pharma Inc | Højkoncentrerede anti-c5-antistofformuleringer |
| CN118370815A (zh) * | 2017-08-22 | 2024-07-23 | 渤健马萨诸塞州股份有限公司 | 含有抗β淀粉样蛋白抗体的药物组合物 |
| AU2018345807B2 (en) | 2017-10-06 | 2025-02-06 | Novo Nordisk A/S | Methods of detecting transthyretin |
| PE20211453A1 (es) * | 2017-11-29 | 2021-08-05 | Prothena Biosciences Ltd | Formulacion liofilizada de un anticuerpo monoclonal contra transtirretina |
| CN120795120A (zh) | 2018-06-05 | 2025-10-17 | 伦敦大学国王学院 | 向胃肠系统递送酬载的btnl3/8导引构建体 |
| US12312394B2 (en) | 2018-06-28 | 2025-05-27 | Alexion Pharmaceuticals, Inc. | Methods of producing anti-C5 antibodies |
| PE20211602A1 (es) * | 2018-12-18 | 2021-08-18 | Novartis Ag | Formulacion de solucion de proteinas que contiene una alta concentracion de un anticuerpo anti-vegf |
| CN120241997A (zh) | 2019-02-18 | 2025-07-04 | 伊莱利利公司 | 治疗性抗体制剂 |
| JP2022521624A (ja) * | 2019-02-26 | 2022-04-11 | イノベント バイオロジックス （スウツォウ） カンパニー，リミテッド | 抗ｃｄ４７抗体を含む製剤、その調製方法および使用 |
| KR20220093347A (ko) | 2019-11-06 | 2022-07-05 | 노파르티스 아게 | 쇼그렌 증후군의 치료 |
| CN113116812A (zh) * | 2019-12-30 | 2021-07-16 | 百奥泰生物制药股份有限公司 | 含抗Trop2抗体-药物偶联物的制剂及其制备方法和应用 |
| EP4090427A1 (en) | 2020-01-13 | 2022-11-23 | Takeda Pharmaceutical Company Limited | Plasma kallikrein inhibitors and uses thereof for treating pediatric hereditary angioedema attack |
| CN115052622B (zh) * | 2020-01-21 | 2026-03-06 | 夏尔巴生物技术(杭州)有限公司 | 重组全人源抗tigit单克隆抗体制剂及其制备方法和用途 |
| WO2022031568A1 (en) * | 2020-08-04 | 2022-02-10 | Novartis Ag | Treatment of cll |
| AU2021320129B2 (en) * | 2020-08-04 | 2025-12-18 | Novartis Ag | Treatment of B cell malignancies |
| US20220193238A1 (en) * | 2020-12-17 | 2022-06-23 | Astrazeneca Ab | Anti-il5r antibody formulations |
| CN115073598B (zh) * | 2021-03-15 | 2024-02-20 | 盛禾(中国)生物制药有限公司 | 一种抗baffr抗体及其应用 |
| IL308044A (en) | 2021-05-04 | 2023-12-01 | Novartis Ag | Treatment of systemic lupus erythematosus using antibuffer antibodies |
| TW202302147A (zh) | 2021-05-04 | 2023-01-16 | 瑞士商諾華公司 | 使用抗baffr抗體治療狼瘡腎炎 |
| AR127163A1 (es) * | 2021-09-29 | 2023-12-27 | Dragonfly Therapeutics Inc | Anticuerpos dirigidos a baff-r y uso de estos |
| TW202432601A (zh) | 2022-11-07 | 2024-08-16 | 美商上游生物公司 | 包含抗人類ｔｓｌｐ受體抗體之醫藥組成物及其使用方法 |
| CN118681009A (zh) * | 2023-03-21 | 2024-09-24 | 百奥泰生物制药股份有限公司 | 一种复方制剂及其应用 |
| CN116712390B (zh) * | 2023-08-04 | 2023-11-14 | 上海览屹医药科技有限公司 | 一种高浓度高稳定性的抗体制剂及其制备方法 |
| WO2025257781A1 (en) * | 2024-06-14 | 2025-12-18 | Novartis Ag | Treatment of systemic sclerosis using anti-baff-r antibodies |
| WO2025263459A1 (ja) * | 2024-06-17 | 2025-12-26 | 学校法人神戸薬科大学 | バイオ医薬品組成物 |
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| ES2252261T3 (es) | 2000-06-28 | 2006-05-16 | Glycofi, Inc. | Metodos para producir glicoproteinas modificadas. |
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| JO3000B1 (ar) | 2004-10-20 | 2016-09-05 | Genentech Inc | مركبات أجسام مضادة . |
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| WO2012076670A2 (en) | 2010-12-10 | 2012-06-14 | Novartis Ag | Antibody formulation |
| WO2013083497A1 (en) | 2011-12-06 | 2013-06-13 | F. Hoffmann-La Roche Ag | Antibody formulation |
| US9216219B2 (en) | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
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2013
- 2013-06-07 US US13/912,355 patent/US9216219B2/en active Active
- 2013-06-10 MA MA37616A patent/MA37616A1/fr unknown
- 2013-06-11 EP EP19185836.4A patent/EP3593814B1/en active Active
- 2013-06-11 PL PL13744818T patent/PL2858671T3/pl unknown
- 2013-06-11 JP JP2015516723A patent/JP6265978B2/ja active Active
- 2013-06-11 CA CA2875386A patent/CA2875386C/en active Active
- 2013-06-11 PT PT137448189T patent/PT2858671T/pt unknown
- 2013-06-11 SI SI201331596T patent/SI2858671T1/sl unknown
- 2013-06-11 NZ NZ630885A patent/NZ630885A/en not_active IP Right Cessation
- 2013-06-11 ES ES13744818T patent/ES2751659T3/es active Active
- 2013-06-11 EA EA201492292A patent/EA033373B1/ru not_active IP Right Cessation
- 2013-06-11 HU HUE13744818A patent/HUE045523T2/hu unknown
- 2013-06-11 SG SG11201408174UA patent/SG11201408174UA/en unknown
- 2013-06-11 DK DK13744818.9T patent/DK2858671T3/da active
- 2013-06-11 EP EP13744818.9A patent/EP2858671B1/en active Active
- 2013-06-11 EP EP26152709.7A patent/EP4725556A2/en active Pending
- 2013-06-11 TW TW102120795A patent/TWI653983B/zh active
- 2013-06-11 BR BR112014030820-9A patent/BR112014030820B1/pt active IP Right Grant
- 2013-06-11 AU AU2013276112A patent/AU2013276112B2/en active Active
- 2013-06-11 MY MYPI2014703690A patent/MY179818A/en unknown
- 2013-06-11 WO PCT/IB2013/054777 patent/WO2013186700A1/en not_active Ceased
- 2013-06-11 HR HRP20191827TT patent/HRP20191827T1/hr unknown
- 2013-06-11 CN CN201380031181.8A patent/CN104363920B/zh active Active
- 2013-06-11 LT LT13744818T patent/LT2858671T/lt unknown
- 2013-06-11 LT LTEP19185836.4T patent/LT3593814T/lt unknown
- 2013-06-11 MX MX2014015262A patent/MX363380B/es unknown
- 2013-06-11 PE PE2014002437A patent/PE20150200A1/es not_active Application Discontinuation
- 2013-06-11 FI FIEP19185836.4T patent/FI3593814T3/fi active
- 2013-06-11 KR KR1020157000336A patent/KR102124820B1/ko active Active
- 2013-06-11 DK DK19185836.4T patent/DK3593814T3/da active
- 2013-06-12 AR ARP130102057 patent/AR091413A1/es not_active Application Discontinuation
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2014
- 2014-11-20 ZA ZA2014/08547A patent/ZA201408547B/en unknown
- 2014-11-21 TN TN2014000488A patent/TN2014000488A1/fr unknown
- 2014-11-27 IL IL235966A patent/IL235966B/en active IP Right Grant
- 2014-12-11 GT GT201400285A patent/GT201400285A/es unknown
- 2014-12-11 PH PH12014502778A patent/PH12014502778A1/en unknown
- 2014-12-11 CL CL2014003370A patent/CL2014003370A1/es unknown
- 2014-12-18 CO CO14278419A patent/CO7151487A2/es unknown
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2015
- 2015-01-12 EC ECIEPI201517314A patent/ECSP15017314A/es unknown
- 2015-11-16 US US14/942,388 patent/US9751951B2/en active Active
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2017
- 2017-08-31 US US15/692,490 patent/US20180051092A1/en not_active Abandoned
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2018
- 2018-05-15 US US15/980,411 patent/US10689451B2/en active Active
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2019
- 2019-10-22 CY CY20191101096T patent/CY1122181T1/el unknown
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