ES2394258T3 - Formas cristalinas de Nilotinib HCL - Google Patents

Formas cristalinas de Nilotinib HCL Download PDF

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Publication number
ES2394258T3
ES2394258T3 ES09752057T ES09752057T ES2394258T3 ES 2394258 T3 ES2394258 T3 ES 2394258T3 ES 09752057 T ES09752057 T ES 09752057T ES 09752057 T ES09752057 T ES 09752057T ES 2394258 T3 ES2394258 T3 ES 2394258T3
Authority
ES
Spain
Prior art keywords
nilotinib hcl
degrees
theta
hcl
nilotinib
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
ES09752057T
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English (en)
Spanish (es)
Inventor
Greta Sterimbaum
Sigalit Levi
Adi Yeori
Tamas Koltai
Valerie Niddam-Hildesheim
Maytal Piran
Shay Asis
Hagit Eisen-Nevo
David Malcolm Crowe
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
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.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41666779&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ES2394258(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Application granted granted Critical
Publication of ES2394258T3 publication Critical patent/ES2394258T3/es
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D403/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings
    • C07D403/04Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings directly linked by a ring-member-to-ring-member bond
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/14Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing three or more hetero rings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D233/00Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
    • C07D233/02Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having no double bonds between ring members or between ring members and non-ring members
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D403/00Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00
    • C07D403/02Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, not provided for by group C07D401/00 containing two hetero rings

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Transition And Organic Metals Composition Catalysts For Addition Polymerization (AREA)
  • Exhaust Gas Treatment By Means Of Catalyst (AREA)
ES09752057T 2008-11-05 2009-11-05 Formas cristalinas de Nilotinib HCL Active ES2394258T3 (es)

Applications Claiming Priority (17)

Application Number Priority Date Filing Date Title
US11156108P 2008-11-05 2008-11-05
US111561P 2008-11-05
US15578909P 2009-02-26 2009-02-26
US155789P 2009-02-26
US17745409P 2009-05-12 2009-05-12
US177454P 2009-05-12
US22721009P 2009-07-21 2009-07-21
US227210P 2009-07-21
US24070909P 2009-09-09 2009-09-09
US240709P 2009-09-09
US24251409P 2009-09-15 2009-09-15
US242514P 2009-09-15
US24679909P 2009-09-29 2009-09-29
US246799P 2009-09-29
US24937609P 2009-10-07 2009-10-07
US249376P 2009-10-07
PCT/US2009/063365 WO2010054056A2 (en) 2008-11-05 2009-11-05 Nilotinib hci crystalline forms

Publications (1)

Publication Number Publication Date
ES2394258T3 true ES2394258T3 (es) 2013-01-30

Family

ID=41666779

Family Applications (1)

Application Number Title Priority Date Filing Date
ES09752057T Active ES2394258T3 (es) 2008-11-05 2009-11-05 Formas cristalinas de Nilotinib HCL

Country Status (12)

Country Link
US (2) US8227477B2 (cg-RX-API-DMAC7.html)
EP (2) EP2530081A3 (cg-RX-API-DMAC7.html)
JP (1) JP5486012B2 (cg-RX-API-DMAC7.html)
KR (2) KR20120111743A (cg-RX-API-DMAC7.html)
CN (1) CN102203084B (cg-RX-API-DMAC7.html)
CA (1) CA2740794A1 (cg-RX-API-DMAC7.html)
DK (1) DK2262793T3 (cg-RX-API-DMAC7.html)
ES (1) ES2394258T3 (cg-RX-API-DMAC7.html)
HR (1) HRP20120793T1 (cg-RX-API-DMAC7.html)
PL (1) PL2262793T3 (cg-RX-API-DMAC7.html)
TW (1) TW201022240A (cg-RX-API-DMAC7.html)
WO (1) WO2010054056A2 (cg-RX-API-DMAC7.html)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011086541A1 (en) * 2010-01-15 2011-07-21 Generics [Uk] Limited Novel polymorph of nilotinib monohydrochloride monohydrate
US20110263701A1 (en) * 2010-04-21 2011-10-27 Sigal Blau Gabapentin enacarbil compositions
EP2571863B1 (en) 2010-06-21 2015-09-23 Teva Pharmaceutical Industries Ltd. Nilotinib salts and crystalline forms thereof
CN103038227A (zh) * 2010-06-21 2013-04-10 特瓦制药工业有限公司 尼洛替尼盐及其晶形
CN102453024B (zh) * 2010-10-27 2014-09-03 浙江九洲药业股份有限公司 一种尼罗替尼盐酸盐晶型及其制备方法
WO2012070062A2 (en) * 2010-11-26 2012-05-31 Hetero Research Foundation Novel polymorph of nilotinib hydrochloride
WO2012164578A1 (en) * 2011-06-02 2012-12-06 Hetero Research Foundation Compositions and methods for preparing immediate release formulations of nilotinib
AR086913A1 (es) * 2011-06-14 2014-01-29 Novartis Ag 4-metil-3-[[4-(3-piridinil)-2-pirimidinil]-amino]-n-[5-(4-metil-1h-imidazol-1-il)-3-(trifluoro-metil)-fenil]-benzamida amorfa, forma de dosificacion que la contiene y metodo para prepararlas
ES2564969T3 (es) * 2012-02-09 2016-03-30 Natco Pharma Limited Proceso para la preparación de clorhidrato de nilotinib
US9061028B2 (en) 2012-02-15 2015-06-23 Natco Pharma Limited Process for the preparation of Nilotinib
EP2906554A4 (en) * 2012-10-15 2016-06-29 Apotex Inc SOLID FORMS OF NILOTINIB HYDROCHLORIDE
US9567317B2 (en) 2012-10-19 2017-02-14 Basf Se Multicomponent crystalline system comprising nilotinib and selected co-crystal formers
BR112015026827A2 (pt) 2013-04-24 2017-09-05 Dr Reddy´S Laboratories Ltd Formas polimórficas de cloridrato de nilotinibe
US9636340B2 (en) 2013-11-12 2017-05-02 Ayyappan K. Rajasekaran Kinase inhibitors
WO2015092624A1 (en) 2013-12-16 2015-06-25 Ranbaxy Laboratories Limited Nilotinib mono-oxalate and its crystalline form
WO2016020891A1 (en) 2014-08-08 2016-02-11 Dr. Reddy’S Laboratories Limited Process for the preparation of polymorphic forms of nilotinib
US10016423B2 (en) 2014-10-16 2018-07-10 Apotex Inc. Solid forms of nilotinib hydrochloride
CN106478603B (zh) * 2015-08-25 2021-01-01 江苏豪森药业集团有限公司 尼洛替尼盐酸盐的新晶型及其制备方法和医药用途
EA036204B1 (ru) * 2015-10-16 2020-10-14 Нобел Илач Санайи Ве Тиджарет А.Ш. Фармацевтические композиции нилотиниба гидрохлорида
WO2017129694A1 (en) 2016-01-26 2017-08-03 Farma Grs, D.O.O. Nilotinib dinitrate (v) and crystalline forms thereof
HUE050890T2 (hu) 2016-03-14 2021-01-28 Pliva Hrvatska D O O Nilotinib sók szilárd halmazállapotú formái
EP3404025B1 (en) 2017-05-16 2019-12-04 F.I.S.- Fabbrica Italiana Sintetici S.p.A. Process for the preparation of pure nilotinib and its salt
CZ2017821A3 (cs) 2017-12-20 2019-07-03 Zentiva, K.S. Léková forma obsahující krystalický nilotinib
EP3806858A4 (en) * 2018-06-15 2022-03-09 Handa Pharmaceuticals, Inc. KINA INHIBITOR SALTS AND COMPOSITIONS THEREOF
US12065426B2 (en) * 2018-11-05 2024-08-20 Laurus Labs Limited Crystalline form of nilotinib hydrochloride, process for its preparation and pharmaceutical composition containing the same
EP4355306A1 (en) 2021-06-19 2024-04-24 Helm AG Granulate composition comprising nilotinib
EP4122452A1 (en) 2021-07-23 2023-01-25 KRKA, d.d., Novo mesto Pharmaceutical composition comprising nilotinib and method of manufacturing the same

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0215676D0 (en) 2002-07-05 2002-08-14 Novartis Ag Organic compounds
GB0325031D0 (en) 2003-10-27 2003-12-03 Novartis Ag Organic compounds
MY146795A (en) 2005-06-09 2012-09-28 Novartis Ag Process for the synthesis of organic compounds
SA06270147B1 (ar) 2005-06-09 2009-12-22 نوفارتيس ايه جي عملية لتخليق 5-(مثيل–1h–إيميدازول–1-يل )–3-(ثلاثي فلـورو مثيل)–بنزامـين
GT200600315A (es) * 2005-07-20 2007-03-19 Formas cristalinas de 4-metilo-n-[3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo]-3-(4-pyridina-3-ilo-pirimidina-2-iloamino)-benzamida
GT200600316A (es) * 2005-07-20 2007-04-02 Sales de 4-metilo-n-(3-(4-metilo-imidazol-1-ilo)-5-trifluorometilo-fenilo)-3-(4-piridina-3-ilo-pirimidina-2-iloamino)- benzamida.
CN101228150B (zh) * 2005-07-20 2014-10-15 诺华股份有限公司 4-甲基-n-[3-(4-甲基-咪唑-1-基)-5-三氟甲基-苯基]-3-(4-吡啶-3-基-嘧啶-2-基氨基)-苯甲酰胺的晶形
KR100674813B1 (ko) 2005-08-05 2007-01-29 일양약품주식회사 N-페닐-2-피리미딘-아민 유도체 및 그의 제조방법
FR2889524B1 (fr) 2005-08-05 2008-08-29 Rhodia Chimie Sas Procede de formation d'une liaison carbone-azote
WO2010009402A2 (en) * 2008-07-17 2010-01-21 Teva Pharmaceutical Industries Ltd. Nilotinib intermediates and preparation thereof

Also Published As

Publication number Publication date
EP2530081A3 (en) 2013-04-10
US20130096304A1 (en) 2013-04-18
US20100190812A1 (en) 2010-07-29
US8592442B2 (en) 2013-11-26
JP5486012B2 (ja) 2014-05-07
KR101251726B1 (ko) 2013-04-05
DK2262793T3 (da) 2012-10-15
EP2262793B1 (en) 2012-10-03
US8227477B2 (en) 2012-07-24
CA2740794A1 (en) 2010-05-14
CN102203084A (zh) 2011-09-28
HRP20120793T1 (hr) 2012-12-31
CN102203084B (zh) 2014-10-29
PL2262793T3 (pl) 2013-01-31
TW201022240A (en) 2010-06-16
JP2012508178A (ja) 2012-04-05
EP2262793A2 (en) 2010-12-22
EP2530081A2 (en) 2012-12-05
KR20100099257A (ko) 2010-09-10
WO2010054056A2 (en) 2010-05-14
KR20120111743A (ko) 2012-10-10
WO2010054056A3 (en) 2010-09-16

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