DK3073999T3 - CRYSTALINE FORM I OF IBRUTINIB - Google Patents

CRYSTALINE FORM I OF IBRUTINIB Download PDF

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Publication number
DK3073999T3
DK3073999T3 DK14866302.4T DK14866302T DK3073999T3 DK 3073999 T3 DK3073999 T3 DK 3073999T3 DK 14866302 T DK14866302 T DK 14866302T DK 3073999 T3 DK3073999 T3 DK 3073999T3
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DK
Denmark
Prior art keywords
ibrutinib
crystalline form
alkane
mixture
ketone
Prior art date
Application number
DK14866302.4T
Other languages
Danish (da)
English (en)
Inventor
Minhua Chen
Yanfeng Zhang
Chaohui Yang
Xiaoyu Zhang
Fei Lu
Heng Ge
Peng Wang
Pixu Li
Original Assignee
Crystal Pharmatech Co Ltd
Suzhou Pengxu Pharmatech Co 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
Application filed by Crystal Pharmatech Co Ltd, Suzhou Pengxu Pharmatech Co Ltd filed Critical Crystal Pharmatech Co Ltd
Application granted granted Critical
Publication of DK3073999T3 publication Critical patent/DK3073999T3/en

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D487/00Heterocyclic compounds containing nitrogen atoms as the only ring hetero atoms in the condensed system, not provided for by groups C07D451/00 - C07D477/00
    • C07D487/02Heterocyclic 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 two hetero rings
    • C07D487/04Ortho-condensed systems
    • 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
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07BGENERAL METHODS OF ORGANIC CHEMISTRY; APPARATUS THEREFOR
    • C07B2200/00Indexing scheme relating to specific properties of organic compounds
    • C07B2200/13Crystalline forms, e.g. polymorphs

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Oncology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
DK14866302.4T 2013-11-27 2014-11-26 CRYSTALINE FORM I OF IBRUTINIB DK3073999T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
CN201310616065.4A CN103694241A (zh) 2013-11-27 2013-11-27 Pci-32765的新晶型a及其制备方法
CN201410542609.1A CN104327085B (zh) 2013-11-27 2014-10-14 Pci-32765的晶型a及其制备方法
PCT/US2014/067586 WO2015081180A1 (en) 2013-11-27 2014-11-26 Crystalline form i of ibrutinib

Publications (1)

Publication Number Publication Date
DK3073999T3 true DK3073999T3 (en) 2018-09-03

Family

ID=50355928

Family Applications (1)

Application Number Title Priority Date Filing Date
DK14866302.4T DK3073999T3 (en) 2013-11-27 2014-11-26 CRYSTALINE FORM I OF IBRUTINIB

Country Status (14)

Country Link
US (1) US9751889B2 (enExample)
EP (1) EP3073999B1 (enExample)
JP (1) JP6483126B2 (enExample)
CN (2) CN103694241A (enExample)
AU (1) AU2014354728B2 (enExample)
CA (1) CA2932059C (enExample)
DK (1) DK3073999T3 (enExample)
ES (1) ES2684094T3 (enExample)
HU (1) HUE039718T2 (enExample)
IL (1) IL245865B (enExample)
MX (1) MX363265B (enExample)
PL (1) PL3073999T3 (enExample)
PT (1) PT3073999T (enExample)
WO (1) WO2015081180A1 (enExample)

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CA3218491A1 (en) 2012-06-04 2013-12-12 Pharmacyclics Llc Crystalline forms of a bruton's tyrosine kinase inhibitor
US9884869B2 (en) 2014-03-27 2018-02-06 Perrigo Api Ltd. Ibrutinib solid forms and production process therefor
CN105085529A (zh) * 2014-05-15 2015-11-25 广东东阳光药业有限公司 依鲁替尼新晶型及其制备方法
MX2017001671A (es) 2014-08-07 2017-07-04 Pharmacyclics Llc Formulaciones novedosas de un inhibidor de la tirosina cinasa de bruton.
CA2958139A1 (en) 2014-08-14 2016-02-18 Assia Chemical Industries Ltd. Solid state forms of ibrutinib
CZ201584A3 (cs) 2015-02-09 2016-08-17 Zentiva, K.S. Sůl Ibrutinib sulfátu
US10477780B2 (en) * 2015-02-13 2019-11-19 Hgci, Inc. Multiple cell tray with media plugs
IL315294A (en) 2015-03-03 2024-10-01 Pharmacyclics Llc Pharmaceutical formulations of bruton's tyrosine kinase inhibitor
WO2016150349A1 (zh) * 2015-03-20 2016-09-29 苏州晶云药物科技有限公司 一种pci-32765晶型a的制备方法
CN106153797B (zh) * 2015-04-20 2017-08-29 北京睿创康泰医药研究院有限公司 一种依鲁替尼及依鲁替尼制剂有关物质分析方法
CN106153798B (zh) * 2015-04-22 2017-08-29 北京睿创康泰医药研究院有限公司 一种用于分析依鲁替尼及依鲁替尼制剂有关物质的hplc方法以及这些杂质做参比标准的用途
WO2017029586A1 (en) * 2015-08-19 2017-02-23 Sun Pharmaceutical Industries Limited Crystalline forms of ibrutinib
ITUB20155616A1 (it) * 2015-11-16 2017-05-16 Laboratorio Chimico Int S P A Procedimento per la preparazione della forma amorfa dell?ibrutinib e nuova forma cristallina.
CN105294696A (zh) * 2015-11-19 2016-02-03 上海创诺医药集团有限公司 依鲁替尼新晶型及其制备方法
CN106905320A (zh) * 2015-12-23 2017-06-30 杭州容立医药科技有限公司 一种适合药用的依鲁替尼及其制剂
CN106995445B (zh) * 2016-01-22 2021-08-03 山东新时代药业有限公司 一种布鲁顿酪氨酸激酶抑制剂晶型及其制备方法
CN107286163A (zh) * 2016-03-30 2017-10-24 上海星泰医药科技有限公司 一种依鲁替尼的新晶型及其制备方法
CZ2016196A3 (cs) 2016-04-06 2017-10-18 Zentiva, K.S. Pevné formy Ibrutinibu
CZ2016276A3 (cs) 2016-05-11 2017-11-22 Zentiva, K.S. Pevné formy volné báze ibrutinibu
CN106117214A (zh) * 2016-06-29 2016-11-16 上海创诺医药集团有限公司 依鲁替尼新晶型及其制备方法
CN106008529A (zh) * 2016-08-08 2016-10-12 上海工程技术大学 一种依鲁替尼溶剂化物及其制备方法
US10183024B2 (en) 2016-12-02 2019-01-22 Apotex Inc. Crystalline forms of ibrutinib
WO2019070698A1 (en) 2017-10-02 2019-04-11 Johnson Matthey Public Limited Company Novel forms of ibrutinib
CZ2017787A3 (cs) 2017-12-08 2019-06-19 Zentiva, K.S. Farmaceutické kompozice obsahující ibrutinib
WO2019195827A1 (en) 2018-04-06 2019-10-10 Johnson Matthey Public Limited Company Novel form of ibrutinib
US20220009929A1 (en) 2018-05-02 2022-01-13 Cipla Limited Polymorphic forms of ibrutinib
EP3787751A1 (en) 2018-05-03 2021-03-10 Juno Therapeutics, Inc. Combination therapy of a chimeric antigen receptor (car) t cell therapy and a kinase inhibitor
EP3575300A1 (en) 2018-05-31 2019-12-04 Apotex Inc. Novel crystalline forms of ibrutinib
CN112313214A (zh) 2018-06-19 2021-02-02 默克专利有限公司 1-(4-{[6-氨基-5-(4-苯氧基-苯基)-嘧啶-4-基氨基]-甲基}-4-氟代-哌啶-1-基)-丙烯酮及其盐形式的新晶体形式以及获得方法
CN111138436A (zh) * 2018-11-04 2020-05-12 鲁南制药集团股份有限公司 伊布替尼晶型a单晶及其制备方法
US10688050B1 (en) 2018-12-21 2020-06-23 Synthon B.V. Pharmaceutical composition comprising ibrutinib
EP3669867A1 (en) 2018-12-21 2020-06-24 Synthon B.V. Pharmaceutical composition comprising ibrutinib
CN113214261A (zh) * 2020-01-21 2021-08-06 尚科生物医药(上海)有限公司 一种依鲁替尼晶型a的纯化方法
US11433072B1 (en) * 2021-06-10 2022-09-06 Hikma Pharmaceuticals USA, Inc. Oral dosage forms of ibrutinib
MA63498A1 (fr) 2021-06-10 2024-07-31 Hikma Pharmaceuticals Usa Inc. Formes posologiques orales d'ibrutinib
WO2023220655A1 (en) 2022-05-11 2023-11-16 Celgene Corporation Methods to overcome drug resistance by re-sensitizing cancer cells to treatment with a prior therapy via treatment with a t cell therapy
WO2023242384A1 (en) 2022-06-17 2023-12-21 Krka, D.D., Novo Mesto Crystalline form of ibrutinib

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Publication number Priority date Publication date Assignee Title
CA2645583A1 (en) 2006-03-20 2007-09-27 F. Hoffman-La Roche Ag Methods of inhibiting btk and syk protein kinases
PT2201840E (pt) * 2006-09-22 2012-02-14 Pharmacyclics Inc Inibidores da tirosina quinase de bruton
RU2013109393A (ru) 2010-08-10 2014-09-20 Сэлджин Авиаломикс Ресеарч, Инк. Безилатная соль ингибитора втк
US9522917B2 (en) 2012-04-11 2016-12-20 Acerta Pharma B.V. Bruton's tyrosine kinase inhibitors for hematopoietic mobilization
WO2013157021A1 (en) * 2012-04-20 2013-10-24 Advinus Therapeutics Limited Bicyclic compounds, compositions and medicinal applications thereof
CA3218491A1 (en) * 2012-06-04 2013-12-12 Pharmacyclics Llc Crystalline forms of a bruton's tyrosine kinase inhibitor
CN103121999A (zh) * 2012-08-29 2013-05-29 苏州迪飞医药科技有限公司 一种酪氨酸激酶抑制剂pci-32765的合成方法
CN103142601A (zh) * 2013-03-13 2013-06-12 杭州雷索药业有限公司 Pci-32765在制备抗血管生成类药物中的应用

Also Published As

Publication number Publication date
IL245865A0 (en) 2016-07-31
ES2684094T3 (es) 2018-10-01
CN103694241A (zh) 2014-04-02
JP6483126B2 (ja) 2019-03-13
AU2014354728A1 (en) 2016-06-16
US20170002009A1 (en) 2017-01-05
AU2014354728B2 (en) 2019-02-28
HUE039718T2 (hu) 2019-02-28
MX363265B (es) 2019-03-19
EP3073999B1 (en) 2018-05-30
PT3073999T (pt) 2018-10-16
CN104327085A (zh) 2015-02-04
CN104327085B (zh) 2016-08-24
CA2932059C (en) 2019-07-02
JP2016538314A (ja) 2016-12-08
IL245865B (en) 2019-05-30
US9751889B2 (en) 2017-09-05
WO2015081180A1 (en) 2015-06-04
PL3073999T3 (pl) 2018-10-31
MX2016006901A (es) 2016-10-28
CA2932059A1 (en) 2015-06-04
EP3073999A4 (en) 2017-03-22
EP3073999A1 (en) 2016-10-05

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