DK3791860T3 - Stabil væskeformig gonadotropinformulering - Google Patents

Stabil væskeformig gonadotropinformulering Download PDF

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Publication number
DK3791860T3
DK3791860T3 DK20202758.7T DK20202758T DK3791860T3 DK 3791860 T3 DK3791860 T3 DK 3791860T3 DK 20202758 T DK20202758 T DK 20202758T DK 3791860 T3 DK3791860 T3 DK 3791860T3
Authority
DK
Denmark
Prior art keywords
informulation
gonadotropine
stable liquid
stable
liquid
Prior art date
Application number
DK20202758.7T
Other languages
English (en)
Other versions
DK3791860T5 (da
Inventor
Helen Ulrika Sjögren
Charlotte Højer-Pedersen
Original Assignee
Ferring Bv
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=55806922&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3791860(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ferring Bv filed Critical Ferring Bv
Application granted granted Critical
Publication of DK3791860T3 publication Critical patent/DK3791860T3/da
Publication of DK3791860T5 publication Critical patent/DK3791860T5/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/24Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Zoology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Gynecology & Obstetrics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Dermatology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
DK20202758.7T 2016-02-24 2017-02-24 Stabil væskeformig gonadotropinformulering DK3791860T5 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB1603280.7A GB201603280D0 (en) 2016-02-24 2016-02-24 Stable liquid gonadotropin formulation
EP17707527.2A EP3419595B1 (en) 2016-02-24 2017-02-24 Stable liquid gonadotropin formulation

Publications (2)

Publication Number Publication Date
DK3791860T3 true DK3791860T3 (da) 2023-12-18
DK3791860T5 DK3791860T5 (da) 2024-08-19

Family

ID=55806922

Family Applications (2)

Application Number Title Priority Date Filing Date
DK20202758.7T DK3791860T5 (da) 2016-02-24 2017-02-24 Stabil væskeformig gonadotropinformulering
DK17707527.2T DK3419595T3 (da) 2016-02-24 2017-02-24 Stabil flydende gonadotropinformulering

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK17707527.2T DK3419595T3 (da) 2016-02-24 2017-02-24 Stabil flydende gonadotropinformulering

Country Status (36)

Country Link
US (4) US10792334B2 (da)
EP (3) EP4257149A3 (da)
JP (3) JP6932710B2 (da)
KR (1) KR102756413B1 (da)
CN (2) CN113398250B (da)
AR (1) AR107782A1 (da)
AU (2) AU2017222292B2 (da)
BR (1) BR112018015166A2 (da)
CA (1) CA3012759A1 (da)
CL (1) CL2018001984A1 (da)
CO (1) CO2018007810A2 (da)
DK (2) DK3791860T5 (da)
EA (1) EA036383B1 (da)
ES (2) ES2862193T3 (da)
FI (1) FI3791860T3 (da)
GB (1) GB201603280D0 (da)
HR (2) HRP20210367T1 (da)
HU (2) HUE064432T2 (da)
IL (1) IL260626B2 (da)
JO (1) JOP20170046B1 (da)
LT (2) LT3419595T (da)
MA (2) MA43686B1 (da)
MD (2) MD3419595T2 (da)
MX (1) MX381709B (da)
MY (1) MY193138A (da)
PH (1) PH12018501688B1 (da)
PL (2) PL3419595T3 (da)
PT (2) PT3791860T (da)
RS (2) RS61604B1 (da)
SG (1) SG11201806140SA (da)
SI (2) SI3791860T1 (da)
TN (1) TN2018000284A1 (da)
TW (1) TWI755377B (da)
UA (1) UA123107C2 (da)
WO (1) WO2017144659A1 (da)
ZA (1) ZA201804944B (da)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
US20190262314A1 (en) * 2018-02-26 2019-08-29 Slayback Pharma Llc Ready-to-use dexmedetomidine compositions
WO2020071912A1 (en) * 2018-10-02 2020-04-09 Innocore Technologies B.V. Extended release formulations of human chorionic gonadotropin (hcg)
CN114404575A (zh) * 2020-12-07 2022-04-29 苏州智核生物医药科技有限公司 一种重组人促甲状腺素注射液
WO2022197963A1 (en) * 2021-03-19 2022-09-22 Pfizer Inc. Long-acting growth hormone compositions
CN118209739A (zh) * 2024-03-19 2024-06-18 厦门宝太和瑞生物技术有限公司 促黄体生成素检测试剂盒
KR102821987B1 (ko) * 2024-10-24 2025-06-26 에이디텍 주식회사 베타 코어 단편 hCG를 유효성분으로 포함하는 난임 치료용 조성물

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0803832A3 (en) 1996-02-28 2000-05-31 Hitachi, Ltd. Card holder-type balance display
IL122732A0 (en) * 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
IL140984A0 (en) * 1998-07-23 2002-02-10 Lilly Co Eli Fsh and fsh variant formulations, products and methods
BRPI0611901A2 (pt) 2005-06-14 2012-08-28 Amgen, Inc composição, liofilizado, kit, e, processo para preparar uma composição
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
GB0700523D0 (en) 2007-01-11 2007-02-21 Insense Ltd The Stabilisation Of Proteins
BRPI0818324B8 (pt) 2007-11-01 2021-05-25 Merck Serono Sa formulação líquida contendo hormônio luteinizante (lh) ou uma variante do mesmo, seu uso, sua forma de apresentação, processo para a sua preparação e composição farmacêutica
US8420081B2 (en) 2007-11-30 2013-04-16 Abbvie, Inc. Antibody formulations and methods of making same
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
NZ586588A (en) 2008-02-08 2012-10-26 Biogenerix Ag Formulation of ( follice stimulating hormone) fsh and varients with benzalkonium chloride and benzyl alcohol
TWI488640B (zh) 2008-04-16 2015-06-21 菲瑞茵國際中心股份有限公司 藥學製劑
KR101668502B1 (ko) 2008-11-04 2016-10-21 아스카 세이야쿠 가부시키가이샤 난포자극호르몬 함유 수성 조성물
RU2553375C2 (ru) * 2010-02-12 2015-06-10 Интас Биофармасьютикалс Лимитед Жидкий состав фолликулостимулирующего гормона
WO2011108010A2 (en) 2010-03-05 2011-09-09 Intas Biopharmaceuticals Limited A thermostable liquid formulation of gonadotropins
EP2417982A1 (en) * 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
AP2016009159A0 (en) * 2013-11-12 2016-04-30 Cadila Healthcare Ltd Formulation for gonadotropins
GB201603280D0 (en) * 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Also Published As

Publication number Publication date
HRP20231477T1 (hr) 2024-03-01
ES2966262T3 (es) 2024-04-19
KR102756413B1 (ko) 2025-01-16
EP4257149A2 (en) 2023-10-11
AU2022200027A1 (en) 2022-02-03
US11666635B2 (en) 2023-06-06
RS61604B1 (sr) 2021-04-29
EA201891905A1 (ru) 2019-02-28
PT3419595T (pt) 2021-03-29
CA3012759A1 (en) 2017-08-31
IL260626A (da) 2018-09-20
US20210236600A1 (en) 2021-08-05
US10792334B2 (en) 2020-10-06
MA43686A (fr) 2019-01-02
MA43686B1 (fr) 2021-03-31
NZ744294A (en) 2024-08-30
TN2018000284A1 (en) 2020-01-16
TWI755377B (zh) 2022-02-21
WO2017144659A1 (en) 2017-08-31
MA52595A (fr) 2021-03-17
SG11201806140SA (en) 2018-08-30
US20230372447A1 (en) 2023-11-23
LT3791860T (lt) 2023-12-11
DK3419595T3 (da) 2021-03-29
CN108883061B (zh) 2021-06-08
JP2021191760A (ja) 2021-12-16
IL260626B1 (en) 2023-04-01
JP2023164573A (ja) 2023-11-10
AR107782A1 (es) 2018-06-06
UA123107C2 (uk) 2021-02-17
MX2018010201A (es) 2019-06-06
EP3419595A1 (en) 2019-01-02
MD3791860T2 (ro) 2024-03-31
KR20180114178A (ko) 2018-10-17
SI3419595T1 (sl) 2021-04-30
PT3791860T (pt) 2023-12-15
LT3419595T (lt) 2021-03-10
DK3791860T5 (da) 2024-08-19
SI3791860T1 (sl) 2024-01-31
BR112018015166A2 (pt) 2018-12-18
CN113398250A (zh) 2021-09-17
US20250352621A1 (en) 2025-11-20
MA52595B1 (fr) 2023-12-29
PH12018501688B1 (en) 2023-08-02
CN108883061A (zh) 2018-11-23
AU2017222292A1 (en) 2018-07-26
RS64929B1 (sr) 2023-12-29
HUE053492T2 (hu) 2021-06-28
EP3419595B1 (en) 2021-01-06
HUE064432T2 (hu) 2024-03-28
GB201603280D0 (en) 2016-04-13
MX381709B (es) 2025-03-13
JOP20170046B1 (ar) 2021-08-17
EP4257149A3 (en) 2023-12-20
IL260626B2 (en) 2023-08-01
MD3419595T2 (ro) 2021-06-30
EP3791860B1 (en) 2023-10-11
JP6932710B2 (ja) 2021-09-08
PL3791860T3 (pl) 2024-03-18
US12447196B2 (en) 2025-10-21
AU2017222292B2 (en) 2021-12-16
JP2019507153A (ja) 2019-03-14
CN113398250B (zh) 2024-02-23
MY193138A (en) 2022-09-26
PL3419595T3 (pl) 2021-06-14
FI3791860T3 (fi) 2024-01-11
CL2018001984A1 (es) 2018-09-14
TW201733612A (zh) 2017-10-01
US20190060409A1 (en) 2019-02-28
ZA201804944B (en) 2023-02-22
CO2018007810A2 (es) 2018-10-22
PH12018501688A1 (en) 2019-05-27
EA036383B1 (ru) 2020-11-03
HRP20210367T1 (hr) 2021-04-16
ES2862193T3 (es) 2021-10-07
EP3791860A1 (en) 2021-03-17

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