HRP20210277T1 - Pripravak za kontroliranu stimulaciju jajnika - Google Patents

Pripravak za kontroliranu stimulaciju jajnika Download PDF

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Publication number
HRP20210277T1
HRP20210277T1 HRP20210277TT HRP20210277T HRP20210277T1 HR P20210277 T1 HRP20210277 T1 HR P20210277T1 HR P20210277T T HRP20210277T T HR P20210277TT HR P20210277 T HRP20210277 T HR P20210277T HR P20210277 T1 HRP20210277 T1 HR P20210277T1
Authority
HR
Croatia
Prior art keywords
product
recombinant human
fsh
patient
dose
Prior art date
Application number
HRP20210277TT
Other languages
English (en)
Inventor
Joan-Carles Arce
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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46785372&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20210277(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Ferring B.V. filed Critical Ferring B.V.
Publication of HRP20210277T1 publication Critical patent/HRP20210277T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/74Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Reproductive Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Pregnancy & Childbirth (AREA)
  • Molecular Biology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)

Claims (12)

1. Proizvod koji sadrži rekombinantni ljudski folikulostimulirajući hormon (FSH) za uporabu u liječenju neplodnosti kod pacijenta s razinom AMH u serumu < 15 pmol/L, pri čemu se proizvod daje u dozi od, ili dozi ekvivalentnoj, 11-13 µg rekombinantnog ljudskog FSH dnevno, pri čemu proizvod nadalje sadrži hCG.
2. Proizvod za uporabu prema patentnom zahtjevu 1 naznačen time što se proizvod daje u dozi od, ili dozi ekvivalentnoj, 12 µg rekombinantnog ljudskog FSH dnevno.
3. Proizvod koji sadrži rekombinantni ljudski folikulostimulirajući hormon (FSH) za uporabu u liječenju neplodnosti kod pacijenta s razinom AMH u serumu ≥ 15 pmol/L, pri čemu se proizvod daje u dozi od, ili dozi ekvivalentnoj, 0,09-0,19 µg rekombinantnog ljudskog FSH po kg tjelesne težine pacijenta dnevno, pri čemu proizvod nadalje sadrži hCG.
4. Proizvod za uporabu prema patentnom zahtjevu 3 u liječenju pacijenta koji ima razinu AMH u serumu od 15 do 24,9 pmol/L, pri čemu se proizvod daje u dozi od ili dozi ekvivalentnoj 0,14 do 0,19 µg rekombinantnog ljudskog FSH po kg tjelesne težine pacijenta dnevno.
5. Proizvod za uporabu prema patentnom zahtjevu 3 u liječenju pacijenta koji ima razinu AMH u serumu od 25 do 34,9 pmol/L, pri čemu se proizvod daje u dozi od ili dozi ekvivalentnoj, 0,11 do 0,14 µg rekombinantnog ljudskog FSH po kg tjelesne težine pacijenta dnevno.
6. Proizvod za uporabu prema patentnom zahtjevu 3 u liječenju pacijenta koji ima razinu AMH u serumu od ≥ 35 pmol/L, pri čemu se proizvod daje u dozi od ili dozi ekvivalentnoj, 0,10 do 0,11 µg ljudskog derivata rekombinantnog ljudskog FSH po kg tjelesne težine pacijenta dnevno.
7. Proizvod za uporabu prema bilo kojem prethodnom patentnom zahtjevu naznačen time što je rekombinantni ljudski FSH rekombinantni ljudski FSH koji uključuje α2, 3- i α2, 6-sialilaciju.
8. Proizvod za uporabu prema patentnom zahtjevu 7 naznačen time što 1 % do 50% ukupne sialilacije je α2, 6-sializacija, i 50% do 99% ukupne sialilacije je α2,3-sializacija.
9. Proizvod koji sadrži rekombinantni ljudski folikulostimulirajući hormon (FSH) naznačen time što je za uporabu u liječenju neplodnosti u skladu s bilo kojim od prethodnih zahtjeva, pri čemu proizvod nadalje sadrži sol koja sadrži farmaceutski prihvatljiv kation alkalijskog metala odabran iz skupine koju čine soli Na+- ili K+- ili njihova kombinacija.
10. Proizvod za uporabu prema bilo kojem prethodnom patentnom zahtjevu naznačen time što je hCG rekombinantni hCG.
11. Proizvod za uporabu prema bilo kojem prethodnom patentnom zahtjevu naznačen time što su FSH i hCG za zajedničku primjenu.
12. Proizvod za uporabu prema bilo kojem od zahtjeva 1 do 10 naznačen time što su FSH i hCG za odvojenu primjenu.
HRP20210277TT 2011-08-08 2021-02-18 Pripravak za kontroliranu stimulaciju jajnika HRP20210277T1 (hr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP11176803 2011-08-08
EP19164277.6A EP3566712B1 (en) 2011-08-08 2012-08-08 Composition for controlled ovarian stimulation

Publications (1)

Publication Number Publication Date
HRP20210277T1 true HRP20210277T1 (hr) 2021-04-02

Family

ID=46785372

Family Applications (8)

Application Number Title Priority Date Filing Date
HRP20230607TT HRP20230607T1 (hr) 2011-08-08 2012-08-08 Pripravak za kontroliranu stimulaciju jajnika
HRP20240420TT HRP20240420T1 (hr) 2011-08-08 2012-08-08 Pripravak za kontroliranu stimulaciju jajnika
HRP20160145TT HRP20160145T1 (hr) 2011-08-08 2016-02-09 Pripravak za kontroliranu stimulaciju jajnika
HRP20181639TT HRP20181639T1 (hr) 2011-08-08 2018-10-10 Pripravak za kontroliranu stimulaciju jajnika
HRP20190023TT HRP20190023T1 (hr) 2011-08-08 2019-01-03 Pripravak za kontroliranu stimulaciju jajnika
HRP20191437 HRP20191437T1 (hr) 2011-08-08 2019-08-08 Sastav za kontroliranu stimulaciju jajnika
HRP20210277TT HRP20210277T1 (hr) 2011-08-08 2021-02-18 Pripravak za kontroliranu stimulaciju jajnika
HRP20210722TT HRP20210722T1 (hr) 2011-08-08 2021-05-10 Pripravak za kontroliranu stimulaciju jajnika

Family Applications Before (6)

Application Number Title Priority Date Filing Date
HRP20230607TT HRP20230607T1 (hr) 2011-08-08 2012-08-08 Pripravak za kontroliranu stimulaciju jajnika
HRP20240420TT HRP20240420T1 (hr) 2011-08-08 2012-08-08 Pripravak za kontroliranu stimulaciju jajnika
HRP20160145TT HRP20160145T1 (hr) 2011-08-08 2016-02-09 Pripravak za kontroliranu stimulaciju jajnika
HRP20181639TT HRP20181639T1 (hr) 2011-08-08 2018-10-10 Pripravak za kontroliranu stimulaciju jajnika
HRP20190023TT HRP20190023T1 (hr) 2011-08-08 2019-01-03 Pripravak za kontroliranu stimulaciju jajnika
HRP20191437 HRP20191437T1 (hr) 2011-08-08 2019-08-08 Sastav za kontroliranu stimulaciju jajnika

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20210722TT HRP20210722T1 (hr) 2011-08-08 2021-05-10 Pripravak za kontroliranu stimulaciju jajnika

Country Status (31)

Country Link
US (4) US9694052B2 (hr)
EP (9) EP3395357B1 (hr)
JP (5) JP6161609B2 (hr)
KR (7) KR102111514B1 (hr)
CN (2) CN107281470A (hr)
AR (1) AR087476A1 (hr)
AU (3) AU2012293647B2 (hr)
BR (2) BR112014002884A2 (hr)
CA (1) CA2844282A1 (hr)
CY (1) CY1117214T1 (hr)
DK (8) DK2821080T3 (hr)
ES (7) ES2742163T3 (hr)
FI (2) FI3756681T3 (hr)
HK (2) HK1204923A1 (hr)
HR (8) HRP20230607T1 (hr)
HU (7) HUE027674T2 (hr)
IL (2) IL300380A (hr)
JO (1) JO3092B1 (hr)
LT (7) LT3395357T (hr)
MX (2) MX348981B (hr)
PL (8) PL3395357T3 (hr)
PT (6) PT2821080T (hr)
RS (8) RS65485B1 (hr)
RU (2) RU2739037C3 (hr)
SA (1) SA112330762B1 (hr)
SI (7) SI3646881T1 (hr)
SM (1) SMT201600038B (hr)
TR (2) TR201900071T4 (hr)
TW (2) TWI555530B (hr)
WO (1) WO2013020996A1 (hr)
ZA (2) ZA201400952B (hr)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI488640B (zh) 2008-04-16 2015-06-21 Ferring Int Ct Sa 藥學製劑
TWI604850B (zh) * 2009-10-05 2017-11-11 菲瑞茵國際中心股份有限公司 藥學製劑
JO3092B1 (ar) 2011-08-08 2017-03-15 Ferring Bv مركب لتحفيز مسيطر عليه للمبيض
WO2016102436A1 (en) * 2014-12-22 2016-06-30 F. Hoffmann-La Roche Ag Cmp-dependent sialidase activity
PL3283097T3 (pl) * 2015-04-17 2020-10-19 Ferring B.V. FSH do leczenia niepłodności
ES2770860T3 (es) 2015-06-26 2020-07-03 Ferring Bv Métodos de purificación y/o inactivación viral
US20180264086A1 (en) * 2015-09-17 2018-09-20 Glycotope Gmbh Mammalian follicle-stimulating hormone composition with increased stability
TWI778979B (zh) 2016-09-30 2022-10-01 瑞士商麥歐文科學有限公司 治療女性不孕症之方法
MA50034B1 (fr) 2017-09-01 2022-02-28 Ferring Bv Composition de stimulation ovarienne contrôlée
JP2021522268A (ja) 2018-04-30 2021-08-30 フェリング ベスローテン フェンノートシャップ 制御された卵巣刺激のための組成物
EP3866833A1 (en) 2018-10-17 2021-08-25 Ferring BV Compositions and methods for controlled ovarian stimulation
US11576920B2 (en) 2019-03-18 2023-02-14 The Menopause Method, Inc. Composition and method to aid in hormone replacement therapy
CN110841060A (zh) * 2019-11-21 2020-02-28 上海交通大学 Choriogonadotropin alfa在治疗多囊卵巢综合征中的应用
TW202237173A (zh) 2020-12-09 2022-10-01 荷蘭商菲林公司 用於受控的卵巢刺激之組成物及方法
WO2023186331A1 (en) 2022-04-01 2023-10-05 Ferring B.V. Mixed protocol for treatment of infertility
WO2023227761A1 (en) 2022-05-26 2023-11-30 Ferring B.V. Compositions and methods for treatment of infertility in males
WO2024008971A1 (en) 2022-07-08 2024-01-11 Ferring B.V. Compositions and methods for intrauterine insemination (iui)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL122732A0 (en) 1997-01-15 1998-08-16 Akzo Nobel Nv Liquid gonadotropin-containing formulation its preparation and a device containing same
EP1074265A1 (en) * 1999-08-03 2001-02-07 Erasmus Universiteit Rotterdam Use of AMH and/or AMH agonists and/or AMH antagonists for long-term control of female fertility
EA007030B1 (ru) * 2001-10-22 2006-06-30 Апплайд Резеч Системз Арс Холдинг Н.В. Гонадотропины для фолликулогенеза
US20040248784A1 (en) * 2003-06-03 2004-12-09 Marco Filicori Unitary combinations of FSH and hCG
US8501719B2 (en) * 2005-11-08 2013-08-06 American Infertility Of New York Androgen treatment in females
TWI488640B (zh) 2008-04-16 2015-06-21 Ferring Int Ct Sa 藥學製劑
TWI604850B (zh) * 2009-10-05 2017-11-11 菲瑞茵國際中心股份有限公司 藥學製劑
EP2417982A1 (en) 2010-07-30 2012-02-15 Ferring B.V. Stabilization of gonadotropins
WO2012016576A1 (en) 2010-08-04 2012-02-09 Glycotope Gmbh Improved recombinant human follicle-stimulating hormone
FI2621517T4 (fi) * 2010-09-29 2024-01-03 Ferring Bv Koostumus käytettäväksi hedelmättömyyden hoidossa
JO3092B1 (ar) 2011-08-08 2017-03-15 Ferring Bv مركب لتحفيز مسيطر عليه للمبيض

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PT3756681T (pt) 2023-07-25
JP6161609B2 (ja) 2017-07-12
TR201911269T4 (tr) 2019-08-21
DK3395357T3 (da) 2019-08-19
HUE062640T2 (hu) 2023-11-28
EP3395357A1 (en) 2018-10-31
JP2020147600A (ja) 2020-09-17
PT3195875T (pt) 2018-10-31
KR102499969B1 (ko) 2023-02-14
PL3566712T3 (pl) 2021-07-12
KR102353144B1 (ko) 2022-01-18
ES2704878T3 (es) 2019-03-20
RU2017106756A3 (hr) 2020-07-09
KR20190140098A (ko) 2019-12-18
RU2017106756A (ru) 2019-01-23
FI4005588T3 (fi) 2024-05-15
HRP20210722T1 (hr) 2021-06-11
WO2013020996A1 (en) 2013-02-14
JP2014522871A (ja) 2014-09-08
KR20210099162A (ko) 2021-08-11
ES2742163T3 (es) 2020-02-13
LT3195875T (lt) 2018-11-12
EP4306174A3 (en) 2024-04-10
LT2821080T (lt) 2019-01-10
RS59107B1 (sr) 2019-09-30
HUE027674T2 (en) 2016-11-28
RS57897B1 (sr) 2019-01-31
TW201716082A (zh) 2017-05-16
IL230696B1 (en) 2023-03-01
LT3566712T (lt) 2021-03-10
CN103732243A (zh) 2014-04-16
IL300380A (en) 2023-04-01
JP7309660B2 (ja) 2023-07-18
HRP20240420T1 (hr) 2024-06-21
RS61672B1 (sr) 2021-04-29
KR20230024442A (ko) 2023-02-20
PT3646881T (pt) 2021-06-02
RS65485B1 (sr) 2024-05-31
JP2023134561A (ja) 2023-09-27
RU2014102924A (ru) 2015-09-20
US20200345814A1 (en) 2020-11-05
PL3395357T3 (pl) 2019-11-29
EP3195875A1 (en) 2017-07-26
TR201900071T4 (tr) 2019-01-21
FI3756681T3 (fi) 2023-07-28
PL4005588T3 (pl) 2024-06-10
EP2821080A1 (en) 2015-01-07
JP2017141253A (ja) 2017-08-17
EP3566712B1 (en) 2021-01-27
PT2821080T (pt) 2018-12-17
DK3646881T3 (da) 2021-07-26
LT3646881T (lt) 2021-05-25
AU2018203222A1 (en) 2018-05-24
EP3756681B1 (en) 2023-05-03
US10624953B2 (en) 2020-04-21
RS54561B1 (en) 2016-06-30
SI3646881T1 (sl) 2021-08-31
JP2019077693A (ja) 2019-05-23
EP2741763A1 (en) 2014-06-18
EP2821080B1 (en) 2018-10-10
SI2741763T1 (sl) 2016-02-29
AR087476A1 (es) 2014-03-26
HUE044610T2 (hu) 2019-11-28
JP6500050B2 (ja) 2019-04-10
KR102111514B1 (ko) 2020-05-18
CN107281470A (zh) 2017-10-24
DK2741763T3 (da) 2016-02-15
EP4005588A1 (en) 2022-06-01
KR102014469B1 (ko) 2019-08-26
BR122020001644B1 (pt) 2022-08-02
EP3395357B1 (en) 2019-05-15
ES2884947T3 (es) 2021-12-13
MX348981B (es) 2017-07-06
AU2018203222B2 (en) 2020-03-12
EP3756681A1 (en) 2020-12-30
RU2613324C3 (ru) 2021-06-09
EP3646881A1 (en) 2020-05-06
RU2739037C3 (ru) 2021-09-08
SI3395357T1 (sl) 2019-09-30
ES2562648T3 (es) 2016-03-07
HRP20181639T1 (hr) 2018-12-14
RU2739037C2 (ru) 2020-12-21
AU2016273925B2 (en) 2018-03-15
EP2741763B1 (en) 2015-11-18
HRP20230607T1 (hr) 2023-09-29
TWI657822B (zh) 2019-05-01
SI2821080T1 (sl) 2019-01-31
EP4005588B1 (en) 2024-02-07
KR20210143934A (ko) 2021-11-29
KR20140054191A (ko) 2014-05-08
IL230696A0 (en) 2014-03-31
PL3646881T3 (pl) 2021-11-02
HUE054312T2 (hu) 2021-08-30
DK3566712T3 (da) 2021-04-19
HUE053716T2 (hu) 2021-07-28
RS64328B1 (sr) 2023-08-31
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RU2613324C2 (ru) 2017-03-15
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AU2012293647B2 (en) 2016-10-06
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PT4005588T (pt) 2024-04-24
US11291708B2 (en) 2022-04-05
US20180028620A1 (en) 2018-02-01
LT3756681T (lt) 2023-07-25
US20140329748A1 (en) 2014-11-06
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KR20200121918A (ko) 2020-10-26
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US20220370567A1 (en) 2022-11-24
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LT4005588T (lt) 2024-03-25
SI3195875T1 (sl) 2018-11-30
JO3092B1 (ar) 2017-03-15
EP3566712A1 (en) 2019-11-13
EP4306174A2 (en) 2024-01-17
PL3756681T3 (pl) 2023-08-21
DK4005588T3 (da) 2024-04-29

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