DK3811927T3 - Stabil, parenteral doseringsform af cetrorelixacetat - Google Patents

Stabil, parenteral doseringsform af cetrorelixacetat Download PDF

Info

Publication number: DK3811927T3
Authority: DK; Denmark
Prior art keywords: cetrorelixacetate; stable; dosage form; parenteral dosage; parenteral
Prior art date: 2019-10-24

Application number

DK20162018.4T

Other languages

English (en)

Inventor

Jaydip Joshi

Rakesh Thummar

Sudeep Agrawal

Subhas Balaram Bhowmick

Arunkumar Yadav

Rajamannar Thennati

Original Assignee

Sun Pharmaceutical Ind 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.)

2019-10-24

Filing date

2020-03-10

Publication date

2021-12-13

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=69784288&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3811927(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2020-03-10 Application filed by Sun Pharmaceutical Ind Ltd filed Critical Sun Pharmaceutical Ind Ltd

2021-12-13 Application granted granted Critical

2021-12-13 Publication of DK3811927T3 publication Critical patent/DK3811927T3/da

Links

108700008462 cetrorelix Proteins 0.000 title 1
KFEFLCOCAHJBEA-ANRVCLKPSA-N cetrorelix acetate Chemical compound CC(O)=O.C([C@@H](C(=O)N[C@H](CCCNC(N)=O)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)N[C@H](C)C(N)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC=1C=NC=CC=1)NC(=O)[C@@H](CC=1C=CC(Cl)=CC=1)NC(=O)[C@@H](CC=1C=C2C=CC=CC2=CC=1)NC(C)=O)C1=CC=C(O)C=C1 KFEFLCOCAHJBEA-ANRVCLKPSA-N 0.000 title 1
229960001865 cetrorelix acetate Drugs 0.000 title 1
239000006201 parenteral dosage form Substances 0.000 title 1

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
- 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
- A61K38/00—Medicinal preparations containing peptides
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/04—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
- 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
- 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
- A61K9/0029—Parenteral nutrition; Parenteral nutrition compositions as drug carriers
- 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
- A61K9/08—Solutions
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/575—Hormones
- C07K14/59—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g.hCG [human chorionic gonadotropin]; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/04—Preparation or injection of sample to be analysed
- G01N30/16—Injection
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N2030/022—Column chromatography characterised by the kind of separation mechanism
- G01N2030/027—Liquid chromatography

Landscapes

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

DK20162018.4T 2019-10-24 2020-03-10 Stabil, parenteral doseringsform af cetrorelixacetat DK3811927T3 (da)

Applications Claiming Priority (1)

Application Number	Priority Date	Filing Date	Title
IN201921043355		2019-10-24

Publications (1)

Publication Number	Publication Date
DK3811927T3 true DK3811927T3 (da)	2021-12-13

Family

ID=69784288

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
DK20162018.4T DK3811927T3 (da)	2019-10-24	2020-03-10	Stabil, parenteral doseringsform af cetrorelixacetat

Country Status (28)

Country	Link
US (2)	US20210121517A1 (da)
EP (2)	EP3811927B8 (da)
JP (1)	JP2023501902A (da)
KR (1)	KR20220114533A (da)
CN (1)	CN114599384A (da)
AR (1)	AR120290A1 (da)
AU (1)	AU2020369236A1 (da)
BR (1)	BR112022007746A2 (da)
CA (1)	CA3155348A1 (da)
CL (1)	CL2022001021A1 (da)
CO (1)	CO2022006820A2 (da)
DK (1)	DK3811927T3 (da)
ES (1)	ES2902784T3 (da)
HR (1)	HRP20211890T1 (da)
HU (1)	HUE058963T2 (da)
IL (1)	IL293908A (da)
JO (1)	JOP20220094A1 (da)
LT (1)	LT3811927T (da)
MA (2)	MA55417B1 (da)
MD (1)	MD3811927T2 (da)
MX (1)	MX2022004859A (da)
PL (1)	PL3811927T3 (da)
PT (1)	PT3811927T (da)
RS (1)	RS62754B1 (da)
SI (1)	SI3811927T1 (da)
TW (1)	TW202128210A (da)
WO (1)	WO2021079339A1 (da)
ZA (1)	ZA202204282B (da)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
PL3811927T3 (pl) *	2019-10-24	2022-02-07	Sun Pharmaceutical Industries Ltd	Trwała pozajelitowa postać dawkowania octanu cetroreliksu
WO2022269572A1 (en)	2021-06-25	2022-12-29	Extrovis Ag	Pharmaceutical compositions
CN115541733A (zh) *	2022-07-14	2022-12-30	南京锐志生物医药有限公司	一种反相色谱法测定保护氨基酸对映异构体的方法
CN115184507B (zh) *	2022-07-27	2024-07-05	南京锐志生物医药有限公司	一种多肽中n,n-二异丙基碳二亚胺和哌啶的检测方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
DE10024451A1 (de)	2000-05-18	2001-11-29	Asta Medica Ag	Pharmazeutische Darreichungsform für Peptide, Verfahren zu deren Herstellung und Verwendung
DE10157628A1 (de)	2001-11-26	2003-06-12	Zentaris Ag	Injektionslösung eines LHRH-Antagonisten
US7214662B2 (en)	2001-11-27	2007-05-08	Zentaris Gmbh	Injectable solution of an LHRH antagonist
WO2003097080A1 (en)	2002-05-15	2003-11-27	Sun Pharmaceutical Industries Limited	A stable aqueous composition of a peptide
BR112013013903A2 (pt)	2010-12-06	2016-09-13	Astron Res Ltd	preparação farmacêutica aquosa estável pronta para uso de cetrorelix para administração parenteral, processo para a fabricação de uma preparação farmacêutica aquosa estável pronta para uso de cetrorelix para uso de cetrorelix para administração parenteral
US20130288968A1 (en)	2012-04-30	2013-10-31	Sun Pharmaceutical Industries Ltd.	Leuprolide injection
US20130303453A1 (en)	2012-05-09	2013-11-14	Sun Pharmaceutical Industries Ltd.	Octreotide injection
EP2823808A1 (en)	2013-07-09	2015-01-14	Ipsen Pharma S.A.S.	Pharmaceutical composition for a sustained release of lanreotide
US20180325993A1 (en)	2017-05-15	2018-11-15	Sun Pharmaceutical Industries Limited	Octreotide injection
CN109467591B (zh) *	2018-12-27	2020-11-03	苏州天马医药集团天吉生物制药有限公司	一种西曲瑞克的纯化方法
PL3811927T3 (pl) *	2019-10-24	2022-02-07	Sun Pharmaceutical Industries Ltd	Trwała pozajelitowa postać dawkowania octanu cetroreliksu

2020
- 2020-03-10 PL PL20162018T patent/PL3811927T3/pl unknown
- 2020-03-10 PT PT201620184T patent/PT3811927T/pt unknown
- 2020-03-10 LT LTEP20162018.4T patent/LT3811927T/lt unknown
- 2020-03-10 RS RS20211515A patent/RS62754B1/sr unknown
- 2020-03-10 HR HRP20211890TT patent/HRP20211890T1/hr unknown
- 2020-03-10 ES ES20162018T patent/ES2902784T3/es active Active
- 2020-03-10 HU HUE20162018A patent/HUE058963T2/hu unknown
- 2020-03-10 DK DK20162018.4T patent/DK3811927T3/da active
- 2020-03-10 EP EP20162018.4A patent/EP3811927B8/en active Active
- 2020-03-10 MA MA55417A patent/MA55417B1/fr unknown
- 2020-03-10 US US16/814,447 patent/US20210121517A1/en active Pending
- 2020-03-10 SI SI202030015T patent/SI3811927T1/sl unknown
- 2020-03-10 MD MDE20220046T patent/MD3811927T2/ro unknown
- 2020-10-23 MX MX2022004859A patent/MX2022004859A/es unknown
- 2020-10-23 AU AU2020369236A patent/AU2020369236A1/en active Pending
- 2020-10-23 US US17/593,512 patent/US20220153802A1/en active Pending
- 2020-10-23 CA CA3155348A patent/CA3155348A1/en active Pending
- 2020-10-23 IL IL293908A patent/IL293908A/en unknown
- 2020-10-23 AR ARP200102937A patent/AR120290A1/es unknown
- 2020-10-23 JO JOP/2022/0094A patent/JOP20220094A1/ar unknown
- 2020-10-23 TW TW109136923A patent/TW202128210A/zh unknown
- 2020-10-23 WO PCT/IB2020/059988 patent/WO2021079339A1/en active Application Filing
- 2020-10-23 MA MA054713A patent/MA54713A/fr unknown
- 2020-10-23 JP JP2022523629A patent/JP2023501902A/ja active Pending
- 2020-10-23 BR BR112022007746A patent/BR112022007746A2/pt unknown
- 2020-10-23 KR KR1020227017349A patent/KR20220114533A/ko unknown
- 2020-10-23 EP EP20800340.0A patent/EP3908259A1/en active Pending
- 2020-10-23 CN CN202080074551.6A patent/CN114599384A/zh active Pending
2022
- 2022-04-14 ZA ZA2022/04282A patent/ZA202204282B/en unknown
- 2022-04-22 CL CL2022001021A patent/CL2022001021A1/es unknown
- 2022-05-24 CO CONC2022/0006820A patent/CO2022006820A2/es unknown

Also Published As

Publication number	Publication date
LT3811927T (lt)	2022-01-10
EP3811927B1 (en)	2021-11-17
MA54713A (fr)	2021-11-17
CA3155348A1 (en)	2021-04-29
WO2021079339A1 (en)	2021-04-29
HUE058963T2 (hu)	2022-10-28
PT3811927T (pt)	2021-12-14
PL3811927T3 (pl)	2022-02-07
MA55417B1 (fr)	2022-02-28
MD3811927T2 (ro)	2022-03-31
BR112022007746A2 (pt)	2022-07-05
JOP20220094A1 (ar)	2023-01-30
KR20220114533A (ko)	2022-08-17
MX2022004859A (es)	2022-05-19
ZA202204282B (en)	2024-01-31
RS62754B1 (sr)	2022-01-31
AR120290A1 (es)	2022-02-09
MA55417A (fr)	2021-04-28
CO2022006820A2 (es)	2022-06-10
CL2022001021A1 (es)	2023-02-03
TW202128210A (zh)	2021-08-01
EP3811927B8 (en)	2022-02-23
JP2023501902A (ja)	2023-01-20
US20210121517A1 (en)	2021-04-29
AU2020369236A1 (en)	2022-05-19
HRP20211890T1 (hr)	2022-03-04
EP3908259A1 (en)	2021-11-17
ES2902784T3 (es)	2022-03-29
CN114599384A (zh)	2022-06-07
SI3811927T1 (sl)	2022-03-31
EP3811927A1 (en)	2021-04-28
US20220153802A1 (en)	2022-05-19
IL293908A (en)	2022-08-01

Publication	Publication Date	Title
DK3811927T3 (da)	2021-12-13	Stabil, parenteral doseringsform af cetrorelixacetat
MA52489A (fr)	2021-03-10	Nouveaux composés
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DK3279202T3 (da)	2020-08-17	Krystal af 3,5-disubstitueret benzenalkynylforbindelse
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DK3571394T3 (da)	2021-03-22	Inertireaktion for netstabilitet
DK3380982T3 (da)	2019-07-22	Håndtering af genom forespørgsel
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DK3458467T3 (da)	2020-12-14	Fremgangsmåde til 6,7-alfa-epoxidering af steroid-4,6-diener
DK3390412T3 (da)	2021-06-21	Vandopløselige derivater af 3,5-diphenyl-diazolforbindelser
DK3347360T3 (da)	2020-01-02	Forbindelser, som er anvendelige til inhibering af ror-gamma-t
MA49522A (fr)	2020-05-06	Nouveaux composés de quinoléinone
DK3576719T3 (da)	2021-10-04	Misbrugsafskrækkende formuleringer på basis af amfetamin
DK3802681T3 (da)	2022-08-15	Anvendelse af kulstofnanofibre, omfattende kulstofnetværk
DK3678644T3 (da)	2023-07-31	Formuleringer af copanlisib
DK3567245T3 (da)	2022-10-10	Drift af vindmølle
DK3601265T3 (da)	2023-09-18	Fast form af (s)-[2-chlor-4-fluor-5-(7-morpholin-4-ylquinazolin-4-yl)phenyl]-(6-methoxy-pyridazin-3-yl)methanol
MA53430A (fr)	2021-06-30	Nouveaux composés
MA49880A (fr)	2020-06-24	Composés anticancéreux
MA53886A (fr)	2022-04-27	Pantalon anti-accélération