EP3193857A4 - Abiraterone acetate formulation and methods of use - Google Patents

Abiraterone acetate formulation and methods of use Download PDF

Info

Publication number: EP3193857A4
Authority: EP; European Patent Office
Prior art keywords: methods; abiraterone acetate; acetate formulation; formulation; abiraterone
Prior art date: 2014-09-18
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 Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Withdrawn

Application number

EP15842591.8A

Other languages

German (de)

French (fr)

Other versions

EP3193857A1 (en

Inventor

Maura Murphy

Paul NEMETH

H. William Bosch

Matthew CALLAHAN

Satya Bhamidipati

Jason Coleman

Christopher Hill

Marck Norret

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.)

Sun Pharma Global FZE

Original Assignee

Iceutica Inc

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.)

2014-09-18

Filing date

2015-09-18

Publication date

2018-04-11

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55533897&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP3193857(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2015-05-08 Priority claimed from US14/707,922 external-priority patent/US20150246060A1/en

2015-09-18 Application filed by Iceutica Inc filed Critical Iceutica Inc

2017-07-26 Publication of EP3193857A1 publication Critical patent/EP3193857A1/en

2018-04-11 Publication of EP3193857A4 publication Critical patent/EP3193857A4/en

Status Withdrawn legal-status Critical Current

Links

229960004103 abiraterone acetate Drugs 0.000 title 1
UVIQSJCZCSLXRZ-UBUQANBQSA-N abiraterone acetate Chemical compound C([C@@H]1[C@]2(C)CC[C@@H]3[C@@]4(C)CC[C@@H](CC4=CC[C@H]31)OC(=O)C)C=C2C1=CC=CN=C1 UVIQSJCZCSLXRZ-UBUQANBQSA-N 0.000 title 1
238000009472 formulation Methods 0.000 title 1
238000000034 method Methods 0.000 title 1
239000000203 mixture Substances 0.000 title 1

Classifications

- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
- 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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- 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

EP15842591.8A 2014-09-18 2015-09-18 Abiraterone acetate formulation and methods of use Withdrawn EP3193857A4 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US201462052294P	2014-09-18	2014-09-18
US14/707,922 US20150246060A1 (en)	2013-03-15	2015-05-08	Abiraterone Acetate Formulation and Methods of Use
PCT/US2015/050889 WO2016044701A1 (en)	2014-09-18	2015-09-18	Abiraterone acetate formulation and methods of use

Publications (2)

Publication Number	Publication Date
EP3193857A1 EP3193857A1 (en)	2017-07-26
EP3193857A4 true EP3193857A4 (en)	2018-04-11

Family

ID=55533897

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP15842591.8A Withdrawn EP3193857A4 (en)	2014-09-18	2015-09-18	Abiraterone acetate formulation and methods of use

Country Status (17)

Country	Link
EP (1)	EP3193857A4 (en)
JP (1)	JP2017528457A (en)
KR (2)	KR102617537B1 (en)
CN (1)	CN106687112A (en)
AP (1)	AP2017009804A0 (en)
AU (1)	AU2015317466A1 (en)
BR (1)	BR112017003219A2 (en)
CA (1)	CA2958316A1 (en)
CO (1)	CO2017002472A2 (en)
EA (1)	EA201790650A1 (en)
IL (1)	IL250270B (en)
MD (1)	MD20170048A2 (en)
MX (1)	MX2017003525A (en)
PH (1)	PH12017500239A1 (en)
SG (1)	SG11201701139YA (en)
TN (2)	TN2017000098A1 (en)
WO (1)	WO2016044701A1 (en)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
EP3824908A1 (en)	2015-04-10	2021-05-26	Capsugel Belgium NV	Abiraterone acetate lipid formulations
EP3606506A4 (en) *	2017-04-07	2021-01-06	MAA Laboratories, Inc.	Methods of improving the solubility and bioavailability of therapeutic agents
CN113473974A (en) *	2019-01-25	2021-10-01	深圳市药欣生物科技有限公司	Pharmaceutical composition
MX2021010553A (en)	2019-03-06	2021-12-15	Propella Therapeutics Inc	Abiraterone prodrugs.
CN110742870B (en) *	2019-12-04	2021-04-20	武汉大学	Abiraterone acetate preparation and preparation method thereof
CN111110646A (en) *	2020-02-19	2020-05-08	纳兰迦(上海)生物医药科技有限公司	Prescription and preparation method of low-specification abiraterone acetate oral preparation
CN113384542B (en) *	2020-03-14	2024-03-29	鲁南制药集团股份有限公司	Tablet of steroid CYP17 inhibitor solid dispersion and preparation method thereof
CA3177094A1 (en) *	2020-05-08	2021-11-11	Janssen Pharmaceutica Nv	Treatment of prostate cancer with a combination of abiraterone acetate and niraparib
EP3944860A1 (en)	2020-07-30	2022-02-02	Galenicum Health S.L.U.	Abiraterone for use in a method of treating cancer
EP4291159A1 (en)	2021-02-15	2023-12-20	Propella Therapeutics, Inc.	Abiraterone prodrugs
KR20240044329A (en)	2022-09-28	2024-04-04	한미약품 주식회사	Oral composite tablet comprising abiraterone acetate and prednisolone

Citations (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2013164473A1 (en) *	2012-05-04	2013-11-07	Jagotec Ag	Pharmaceutical composition comprising abiraterone acetate
WO2014009437A1 (en) *	2012-07-11	2014-01-16	Sandoz Ag	Oxidation stability of abiraterone acetate
WO2014145813A1 (en) *	2013-03-15	2014-09-18	Iceutica Inc.	Abiraterone acetate formulation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
BRPI1014276B8 (en) *	2009-04-24	2021-05-25	Iceutica Pty Ltd	production of encapsulated nanoparticles on a commercial scale
WO2014009434A1 (en) *	2012-07-11	2014-01-16	Sandoz Ag	Self-microemulsifying drug delivery system of abiraterone or abiraterone acetate
WO2014009436A1 (en) *	2012-07-11	2014-01-16	Sandoz Ag	Nanosuspension of abiraterone acetate
CN102743393A (en) *	2012-07-27	2012-10-24	海南盛科生命科学研究院	Medicinal composition containing abiraterone acetate and preparation technology thereof

2015
- 2015-09-18 MX MX2017003525A patent/MX2017003525A/en unknown
- 2015-09-18 WO PCT/US2015/050889 patent/WO2016044701A1/en active Application Filing
- 2015-09-18 EA EA201790650A patent/EA201790650A1/en unknown
- 2015-09-18 KR KR1020237001893A patent/KR102617537B1/en active IP Right Grant
- 2015-09-18 MD MDA20170048A patent/MD20170048A2/en not_active Application Discontinuation
- 2015-09-18 TN TN2017000098A patent/TN2017000098A1/en unknown
- 2015-09-18 JP JP2017512783A patent/JP2017528457A/en active Pending
- 2015-09-18 CA CA2958316A patent/CA2958316A1/en active Pending
- 2015-09-18 AU AU2015317466A patent/AU2015317466A1/en not_active Abandoned
- 2015-09-18 TN TNP/2018/000318A patent/TN2018000318A1/en unknown
- 2015-09-18 AP AP2017009804A patent/AP2017009804A0/en unknown
- 2015-09-18 EP EP15842591.8A patent/EP3193857A4/en not_active Withdrawn
- 2015-09-18 SG SG11201701139YA patent/SG11201701139YA/en unknown
- 2015-09-18 BR BR112017003219A patent/BR112017003219A2/en not_active IP Right Cessation
- 2015-09-18 CN CN201580050453.8A patent/CN106687112A/en active Pending
- 2015-09-18 KR KR1020177008938A patent/KR102491439B1/en active IP Right Grant
2017
- 2017-01-25 IL IL250270A patent/IL250270B/en active IP Right Grant
- 2017-02-09 PH PH12017500239A patent/PH12017500239A1/en unknown
- 2017-03-15 CO CONC2017/0002472A patent/CO2017002472A2/en unknown

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO2013164473A1 (en) *	2012-05-04	2013-11-07	Jagotec Ag	Pharmaceutical composition comprising abiraterone acetate
WO2014009437A1 (en) *	2012-07-11	2014-01-16	Sandoz Ag	Oxidation stability of abiraterone acetate
WO2014145813A1 (en) *	2013-03-15	2014-09-18	Iceutica Inc.	Abiraterone acetate formulation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2016044701A1 *

Also Published As

Publication number	Publication date
TN2018000318A1 (en)	2020-01-16
SG11201701139YA (en)	2017-03-30
CA2958316A1 (en)	2016-03-24
MD20170048A2 (en)	2017-08-31
KR102491439B1 (en)	2023-01-25
KR20230014878A (en)	2023-01-30
JP2017528457A (en)	2017-09-28
MX2017003525A (en)	2017-06-21
IL250270A0 (en)	2017-03-30
AU2015317466A1 (en)	2017-02-23
KR20170070025A (en)	2017-06-21
BR112017003219A2 (en)	2017-11-28
CN106687112A (en)	2017-05-17
CO2017002472A2 (en)	2017-07-11
KR102617537B1 (en)	2023-12-22
EA201790650A1 (en)	2017-07-31
AP2017009804A0 (en)	2017-03-31
PH12017500239A1 (en)	2017-07-03
TN2017000098A1 (en)	2018-10-19
WO2016044701A1 (en)	2016-03-24
IL250270B (en)	2021-02-28
EP3193857A1 (en)	2017-07-26

Legal Events

Date	Code	Title	Description
2017-06-23	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2017-07-26	17P	Request for examination filed	Effective date: 20170418
2017-07-26	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2017-07-26	AX	Request for extension of the european patent	Extension state: BA ME
2017-12-27	DAV	Request for validation of the european patent (deleted)
2017-12-27	DAX	Request for extension of the european patent (deleted)
2018-04-11	A4	Supplementary search report drawn up and despatched	Effective date: 20180308
2018-04-11	RIC1	Information provided on ipc code assigned before grant	Ipc: C07J 43/00 20060101ALI20180303BHEP Ipc: A61K 31/19 20060101AFI20180303BHEP Ipc: A61K 9/20 20060101ALI20180303BHEP Ipc: A61P 13/08 20060101ALI20180303BHEP Ipc: A61K 31/58 20060101ALI20180303BHEP
2018-06-08	REG	Reference to a national code	Ref country code: HK Ref legal event code: DE Ref document number: 1241293 Country of ref document: HK
2019-09-18	17Q	First examination report despatched	Effective date: 20190820
2019-10-09	RAP1	Party data changed (applicant data changed or rights of an application transferred)	Owner name: SUN PHARMA GLOBAL FZE
2020-06-26	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN
2020-07-29	18D	Application deemed to be withdrawn	Effective date: 20200103
2024-04-12	REG	Reference to a national code	Ref country code: HK Ref legal event code: WD Ref document number: 1241293 Country of ref document: HK

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