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
Publication of DK3791860T3 publication Critical patent/DK3791860T3/da
Application granted granted Critical
Publication of DK3791860T5 publication Critical patent/DK3791860T5/da

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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
    • A61K9/08—Solutions
    • 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
    • A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61K47/20—Organic 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs 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
DK17707527.2T DK3419595T3 (da) 2016-02-24 2017-02-24 Stabil flydende gonadotropinformulering
DK20202758.7T DK3791860T5 (da) 2016-02-24 2017-02-24 Stabil væskeformig gonadotropinformulering

Family Applications Before (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) EP3791860B1 (da)
JP (3) JP6932710B2 (da)
KR (1) KR102756413B1 (da)
CN (2) CN108883061B (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) DK3419595T3 (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) LT3791860T (da)
MA (2) MA43686B1 (da)
MD (2) MD3791860T2 (da)
MX (1) MX381709B (da)
MY (1) MY193138A (da)
PH (1) PH12018501688B1 (da)
PL (2) PL3791860T3 (da)
PT (2) PT3419595T (da)
RS (2) RS64929B1 (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
WO2019164765A1 (en) * 2018-02-26 2019-08-29 Slayback Pharma Llc Ready-to-use dexmedetomidine compositions
BR112021006406A2 (pt) * 2018-10-02 2021-07-06 Innocore Tech Holding B V forma de dosagem de gonadotrofina coriônica humana (hcg) de liberação prolongada
CN112451652A (zh) * 2020-12-07 2021-03-09 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
CA2198299C (en) 1996-02-28 2000-05-02 Yuhei Abe Card holder-type balance display
TW518235B (en) * 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
CA2335340C (en) * 1998-07-23 2013-03-05 Eli Lilly And Company Fsh and fsh variant formulations, products and methods
JP2008543839A (ja) 2005-06-14 2008-12-04 アムジェン インコーポレーテッド 自己緩衝タンパク質製剤
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
ES2393233T3 (es) * 2007-11-01 2012-12-19 Merck Serono S.A. Formulaciones de LH líquidas
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
RS52106B (sr) 2008-02-08 2012-08-31 Biogenerix Ag Tečni preparat fsh
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
RU2561057C2 (ru) 2008-11-04 2015-08-20 Аска Фармасьютикал Ко., Лтд. Водная композиция, содержащая фолликулостимулирующий гормон
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
HK1223559A1 (zh) * 2013-11-12 2017-08-04 Cadila Healthcare Limited 用於促性腺激素的配方
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation

Also Published As

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

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