PL4512390T1 - Wytwarzanie degareliksu - Google Patents

Wytwarzanie degareliksu

Info

Publication number: PL4512390T1
Authority: PL; Poland
Prior art keywords: degarelix; manufacture
Prior art date: 2012-06-01

Application number

PL25151068.1T

Other languages

English (en)

Inventor

Grégoire SCHWACH

Anders Nilsson

Tine Elisabeth GOTTSCHALK BOEVING

Jon Holbech Rasmussen

Birgitta MÖRNSTAM

Anders TSIRK

Ulf Annby

Jens Fomsgaard

Original Assignee

Ferring B.V.

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.)

2012-06-01

Filing date

2013-05-31

Publication date

2025-09-01

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48539181&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL4512390(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2013-05-31 Application filed by Ferring B.V. filed Critical Ferring B.V.

2025-09-01 Publication of PL4512390T1 publication Critical patent/PL4512390T1/pl

Links

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
- A61K38/08—Peptides having 5 to 11 amino acids
- A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/25—Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
- 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
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
- 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
- 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
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
- C07K7/04—Linear peptides containing only normal peptide links
- C07K7/23—Luteinising hormone-releasing hormone [LHRH]; Related peptides

Landscapes

Health & Medical Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
General Health & Medical Sciences (AREA)
Engineering & Computer Science (AREA)
Public Health (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Bioinformatics & Cheminformatics (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Gastroenterology & Hepatology (AREA)
Immunology (AREA)
Molecular Biology (AREA)
Endocrinology (AREA)
Chemical Kinetics & Catalysis (AREA)
General Chemical & Material Sciences (AREA)
Oil, Petroleum & Natural Gas (AREA)
Organic Chemistry (AREA)
Biophysics (AREA)
Biochemistry (AREA)
Dermatology (AREA)
Biomedical Technology (AREA)
Neurosurgery (AREA)
Reproductive Health (AREA)
Zoology (AREA)
Genetics & Genomics (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Peptides Or Proteins (AREA)
Medicinal Preparation (AREA)

PL25151068.1T 2012-06-01 2013-05-31 Wytwarzanie degareliksu PL4512390T1 (pl)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
EP12170454		2012-06-01

Publications (1)

Publication Number	Publication Date
PL4512390T1 true PL4512390T1 (pl)	2025-09-01

Family

ID=48539181

Family Applications (3)

Application Number	Title	Priority Date	Filing Date
PL25151068.1T PL4512390T1 (pl)	2012-06-01	2013-05-31	Wytwarzanie degareliksu
PL13726219.2T PL2854831T3 (pl)	2012-06-01	2013-05-31	Wytwarzanie degareliksu
PL25151066.5T PL4512389T1 (pl)	2012-06-01	2013-05-31	Produkt leczniczy degareliksu

Family Applications After (2)

Application Number	Title	Priority Date	Filing Date
PL13726219.2T PL2854831T3 (pl)	2012-06-01	2013-05-31	Wytwarzanie degareliksu
PL25151066.5T PL4512389T1 (pl)	2012-06-01	2013-05-31	Produkt leczniczy degareliksu

Country Status (28)

Country	Link
US (5)	US9592266B2 (pl)
EP (4)	EP2854831B1 (pl)
JP (1)	JP6226966B2 (pl)
KR (1)	KR102140982B1 (pl)
CN (2)	CN104334182B (pl)
AR (2)	AR092840A1 (pl)
AU (1)	AU2013269523B2 (pl)
CA (2)	CA3228586A1 (pl)
DE (1)	DE25151068T1 (pl)
DK (1)	DK2854831T3 (pl)
ES (3)	ES3037257T1 (pl)
FI (3)	FI4512390T1 (pl)
HR (1)	HRP20241284T1 (pl)
HU (1)	HUE068579T2 (pl)
IL (1)	IL235856B (pl)
JO (1)	JO3586B1 (pl)
LT (1)	LT2854831T (pl)
MX (1)	MX364010B (pl)
MY (1)	MY182320A (pl)
NZ (2)	NZ727679A (pl)
PH (1)	PH12014502682A1 (pl)
PL (3)	PL4512390T1 (pl)
RS (1)	RS66065B1 (pl)
RU (1)	RU2657444C2 (pl)
SG (1)	SG11201407679PA (pl)
SI (1)	SI2854831T1 (pl)
TW (1)	TWI580443B (pl)
WO (1)	WO2013178788A2 (pl)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
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TWI442932B (zh)	2008-02-11	2014-07-01	Ferring Int Ct Sa	以ＧｎＲＨ拮抗劑治療攝護腺癌的方法
PL4512390T1 (pl)	2012-06-01	2025-09-01	Ferring B.V.	Wytwarzanie degareliksu
CN107693496A (zh) *	2017-10-23	2018-02-16	天津双硕医药科技有限公司	一种注射用地加瑞克冻干粉针及制备工艺
EP3590526A1 (en) *	2018-07-05	2020-01-08	Antev Limited	A lyophilization process and a teverelix-tfa lyophilizate obtained thereby
CN111036078B (zh) *	2018-10-14	2022-04-26	深圳市健元医药科技有限公司	一种GnRH拮抗剂的后处理方法
CN112125956A (zh) *	2019-06-25	2020-12-25	深圳市健元医药科技有限公司	一种地加瑞克的制备方法
CA3159716A1 (en) *	2019-12-05	2021-06-10	Fresenius Kabi Usa, Llc	Method for analyzing degarelix and associated products
CN114460179B (zh) *	2020-11-09	2024-10-18	深圳市健翔生物制药有限公司	一种注射用醋酸地加瑞克体外释放度的测定方法
CN114671927A (zh) *	2020-12-24	2022-06-28	深圳翰宇药业股份有限公司	地加瑞克粗肽的制备方法

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TWI442932B (zh)	2008-02-11	2014-07-01	Ferring Int Ct Sa	以ＧｎＲＨ拮抗劑治療攝護腺癌的方法
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TW201043221A (en)	2009-05-06	2010-12-16	Ferring Int Ct Sa	Kit and method for preparation of a Degarelix solution
US20110039787A1 (en)	2009-07-06	2011-02-17	Ferring International Center S.A.	Compositions, kits and methods for treating benign prostate hyperplasia
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EP2447276A1 (en)	2010-10-27	2012-05-02	Ferring B.V.	Process for the manufacture of Degarelix and its intermediates
PT2632934T (pt)	2010-10-27	2017-01-06	Ferring Bv	Processo para o fabrico de degarelix e seus intermediários
JO3755B1 (ar)	2011-01-26	2021-01-31	Ferring Bv	تركيبات تستوستيرون
CN102204889B (zh) *	2011-05-23	2013-09-18	蚌埠丰原涂山制药有限公司	一种醋酸地加瑞克冻干粉针剂及其制备方法
US9669110B2 (en)	2011-07-15	2017-06-06	Ferring B.V.	Method for timing a colonoscopy
CN102329373B (zh)	2011-09-29	2014-10-22	深圳翰宇药业股份有限公司	地加瑞克的固相合成工艺
PL4512390T1 (pl)	2012-06-01	2025-09-01	Ferring B.V.	Wytwarzanie degareliksu

2013
- 2013-05-31 PL PL25151068.1T patent/PL4512390T1/pl unknown
- 2013-05-31 RS RS20241121A patent/RS66065B1/sr unknown
- 2013-05-31 EP EP13726219.2A patent/EP2854831B1/en active Active
- 2013-05-31 TW TW102119333A patent/TWI580443B/zh active
- 2013-05-31 PL PL13726219.2T patent/PL2854831T3/pl unknown
- 2013-05-31 NZ NZ727679A patent/NZ727679A/en unknown
- 2013-05-31 CA CA3228586A patent/CA3228586A1/en active Pending
- 2013-05-31 MX MX2014014662A patent/MX364010B/es active IP Right Grant
- 2013-05-31 JP JP2015514527A patent/JP6226966B2/ja active Active
- 2013-05-31 EP EP24172290.9A patent/EP4385517A3/en active Pending
- 2013-05-31 HR HRP20241284TT patent/HRP20241284T1/hr unknown
- 2013-05-31 RU RU2014146272A patent/RU2657444C2/ru active
- 2013-05-31 WO PCT/EP2013/061264 patent/WO2013178788A2/en not_active Ceased
- 2013-05-31 NZ NZ701978A patent/NZ701978A/en unknown
- 2013-05-31 CN CN201380028448.8A patent/CN104334182B/zh active Active
- 2013-05-31 FI FIEP25151068.1T patent/FI4512390T1/fi unknown
- 2013-05-31 CN CN201710709810.8A patent/CN107569456A/zh active Pending
- 2013-05-31 DK DK13726219.2T patent/DK2854831T3/da active
- 2013-05-31 ES ES25151068T patent/ES3037257T1/es active Pending
- 2013-05-31 DE DE25151068.1T patent/DE25151068T1/de active Pending
- 2013-05-31 US US14/403,775 patent/US9592266B2/en active Active
- 2013-05-31 ES ES13726219T patent/ES2988481T3/es active Active
- 2013-05-31 EP EP25151068.1A patent/EP4512390B1/en active Active
- 2013-05-31 CA CA2874927A patent/CA2874927A1/en active Pending
- 2013-05-31 FI FIEP13726219.2T patent/FI2854831T3/fi active
- 2013-05-31 SI SI201332090T patent/SI2854831T1/sl unknown
- 2013-05-31 FI FIEP25151066.5T patent/FI4512389T1/fi unknown
- 2013-05-31 AU AU2013269523A patent/AU2013269523B2/en active Active
- 2013-05-31 AR ARP130101926A patent/AR092840A1/es not_active Application Discontinuation
- 2013-05-31 LT LTEPPCT/EP2013/061264T patent/LT2854831T/lt unknown
- 2013-05-31 ES ES25151066T patent/ES3037194T1/es active Pending
- 2013-05-31 KR KR1020147035636A patent/KR102140982B1/ko active Active
- 2013-05-31 PL PL25151066.5T patent/PL4512389T1/pl unknown
- 2013-05-31 SG SG11201407679PA patent/SG11201407679PA/en unknown
- 2013-05-31 EP EP25151066.5A patent/EP4512389B1/en active Active
- 2013-05-31 MY MYPI2014703537A patent/MY182320A/en unknown
- 2013-05-31 HU HUE13726219A patent/HUE068579T2/hu unknown
- 2013-06-02 JO JOP/2013/0167A patent/JO3586B1/ar active
2014
- 2014-11-23 IL IL235856A patent/IL235856B/en active IP Right Grant
- 2014-12-01 PH PH12014502682A patent/PH12014502682A1/en unknown
2017
- 2017-01-31 US US15/420,156 patent/US10172906B2/en active Active
2018
- 2018-12-19 US US16/224,843 patent/US10765721B2/en active Active
2020
- 2020-07-30 US US16/947,382 patent/US11260102B2/en active Active
2021
- 2021-01-21 US US17/154,690 patent/US11510962B2/en active Active
- 2021-09-27 AR ARP210102681A patent/AR123619A2/es not_active Application Discontinuation

Also Published As

Publication number	Publication date
PL2854831T3 (pl)	2024-11-25
AU2013269523A1 (en)	2015-01-15
US20210077564A1 (en)	2021-03-18
WO2013178788A2 (en)	2013-12-05
IL235856A0 (en)	2015-01-29
US9592266B2 (en)	2017-03-14
EP4512390A2 (en)	2025-02-26
EP4385517A3 (en)	2024-11-13
ES3037257T1 (en)	2025-09-30
JP2015518866A (ja)	2015-07-06
MY182320A (en)	2021-01-19
EP4512389A2 (en)	2025-02-26
AR123619A2 (es)	2022-12-21
HK1209046A1 (en)	2016-03-24
PH12014502682B1 (en)	2015-01-26
US11260102B2 (en)	2022-03-01
CN104334182B (zh)	2017-09-08
IL235856B (en)	2018-12-31
FI4512389T1 (fi)	2025-08-01
AR092840A1 (es)	2015-05-06
RS66065B1 (sr)	2024-11-29
US20190224271A1 (en)	2019-07-25
CN107569456A (zh)	2018-01-12
MX364010B (es)	2019-04-11
AU2013269523B2 (en)	2017-09-28
RU2014146272A (ru)	2016-07-27
TWI580443B (zh)	2017-05-01
EP4512390A3 (en)	2025-06-25
LT2854831T (lt)	2024-10-10
KR102140982B1 (ko)	2020-08-05
TW201400143A (zh)	2014-01-01
KR20150022854A (ko)	2015-03-04
NZ727679A (en)	2018-05-25
DK2854831T3 (da)	2024-10-14
PH12014502682A1 (en)	2015-01-26
FI2854831T3 (fi)	2024-10-15
WO2013178788A3 (en)	2014-02-27
JO3586B1 (ar)	2020-07-05
CA2874927A1 (en)	2013-12-05
CN104334182A (zh)	2015-02-04
US20170319644A1 (en)	2017-11-09
US20150141337A1 (en)	2015-05-21
PL4512389T1 (pl)	2025-09-01
EP4512389A3 (en)	2025-06-18
US10765721B2 (en)	2020-09-08
SI2854831T1 (sl)	2024-11-29
EP2854831B1 (en)	2024-07-10
SG11201407679PA (en)	2014-12-30
CA3228586A1 (en)	2013-12-05
HRP20241284T1 (hr)	2024-12-06
FI4512390T1 (fi)	2025-08-01
US20210138024A1 (en)	2021-05-13
HUE068579T2 (hu)	2025-01-28
ES3037194T1 (en)	2025-09-30
EP4512390B1 (en)	2026-01-28
US10172906B2 (en)	2019-01-08
EP4512389B1 (en)	2026-02-04
RU2657444C2 (ru)	2018-06-13
DE25151068T1 (de)	2025-10-02
NZ701978A (en)	2016-12-23
EP4385517A2 (en)	2024-06-19
JP6226966B2 (ja)	2017-11-08
BR112014029495A2 (pt)	2017-06-27
US11510962B2 (en)	2022-11-29
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ES2988481T3 (es)	2024-11-20
MX2014014662A (es)	2015-02-24

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