IN2013MU03559A - - Google Patents

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Publication number
IN2013MU03559A
IN2013MU03559A IN3559MU2013A IN2013MU03559A IN 2013MU03559 A IN2013MU03559 A IN 2013MU03559A IN 3559MU2013 A IN3559MU2013 A IN 3559MU2013A IN 2013MU03559 A IN2013MU03559 A IN 2013MU03559A
Authority
IN
India
Prior art keywords
gonadotropins
fragmentation
provides
dose form
aggregation
Prior art date
Application number
Other languages
English (en)
Inventor
Chintan Patel
Mukesh Mahajan
Sanjay Bandyopadhyay
Sanjeev Kumar Mendiratta
Original Assignee
Cadila Healthcare 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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=52684607&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=IN2013MU03559(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to EP14845007.5A priority Critical patent/EP3068374A1/en
Priority to AP2016009159A priority patent/AP2016009159A0/en
Priority to PCT/IN2014/000691 priority patent/WO2015075743A1/en
Priority to US15/030,527 priority patent/US20160250295A1/en
Priority to IN3559MU2013 priority patent/IN2013MU03559A/en
Priority to JP2016525079A priority patent/JP6166470B2/ja
Priority to HK16111891.9A priority patent/HK1223559A1/zh
Priority to NZ718960A priority patent/NZ718960A/en
Application filed by Cadila Healthcare Ltd filed Critical Cadila Healthcare Ltd
Priority to CN201480057647.6A priority patent/CN105658201A/zh
Priority to SG11201603142YA priority patent/SG11201603142YA/en
Priority to CA2928311A priority patent/CA2928311A1/en
Priority to KR1020167010341A priority patent/KR101699677B1/ko
Priority to AU2014351326A priority patent/AU2014351326B2/en
Priority to MX2016005154A priority patent/MX356383B/es
Priority to EA201690626A priority patent/EA201690626A1/ru
Priority to TW103138047A priority patent/TWI579003B/zh
Priority to ARP140104243A priority patent/AR098386A1/es
Publication of IN2013MU03559A publication Critical patent/IN2013MU03559A/en
Priority to IL244986A priority patent/IL244986A/en
Priority to ZA2016/02718A priority patent/ZA201602718B/en
Priority to PH12016500738A priority patent/PH12016500738A1/en
Priority to CL2016000944A priority patent/CL2016000944A1/es

Links

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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Endocrinology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Zoology (AREA)
  • Reproductive Health (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
IN3559MU2013 2013-11-12 2014-10-31 IN2013MU03559A (enExample)

Priority Applications (21)

Application Number Priority Date Filing Date Title
EA201690626A EA201690626A1 (ru) 2013-11-12 2014-10-31 Новый состав гонадотропинов
SG11201603142YA SG11201603142YA (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
PCT/IN2014/000691 WO2015075743A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
US15/030,527 US20160250295A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
IN3559MU2013 IN2013MU03559A (enExample) 2013-11-12 2014-10-31
JP2016525079A JP6166470B2 (ja) 2013-11-12 2014-10-31 ゴナドトロピンのための新規製剤
HK16111891.9A HK1223559A1 (zh) 2013-11-12 2014-10-31 用於促性腺激素的配方
KR1020167010341A KR101699677B1 (ko) 2013-11-12 2014-10-31 고나도트로핀을 위한 제제
AP2016009159A AP2016009159A0 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
CN201480057647.6A CN105658201A (zh) 2013-11-12 2014-10-31 促性腺激素的制剂
CA2928311A CA2928311A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
EP14845007.5A EP3068374A1 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
NZ718960A NZ718960A (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
AU2014351326A AU2014351326B2 (en) 2013-11-12 2014-10-31 Formulation for gonadotropins
MX2016005154A MX356383B (es) 2013-11-12 2014-10-31 Formulación líquida de gonadotropina estabilizada con polietilenglicol.
TW103138047A TWI579003B (zh) 2013-11-12 2014-11-03 促性腺激素之新穎調製劑
ARP140104243A AR098386A1 (es) 2013-11-12 2014-11-11 Formulación para gonadotropinas
IL244986A IL244986A (en) 2013-11-12 2016-04-07 Formulation for gonadotropins
ZA2016/02718A ZA201602718B (en) 2013-11-12 2016-04-20 Formulation for gonadotropins
PH12016500738A PH12016500738A1 (en) 2013-11-12 2016-04-20 Formulation for gonadotropins
CL2016000944A CL2016000944A1 (es) 2013-11-12 2016-04-20 Nueva formulación de ganadotropinas

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN3559MU2013 IN2013MU03559A (enExample) 2013-11-12 2014-10-31

Publications (1)

Publication Number Publication Date
IN2013MU03559A true IN2013MU03559A (enExample) 2015-07-24

Family

ID=52684607

Family Applications (1)

Application Number Title Priority Date Filing Date
IN3559MU2013 IN2013MU03559A (enExample) 2013-11-12 2014-10-31

Country Status (21)

Country Link
US (1) US20160250295A1 (enExample)
EP (1) EP3068374A1 (enExample)
JP (1) JP6166470B2 (enExample)
KR (1) KR101699677B1 (enExample)
CN (1) CN105658201A (enExample)
AP (1) AP2016009159A0 (enExample)
AR (1) AR098386A1 (enExample)
AU (1) AU2014351326B2 (enExample)
CA (1) CA2928311A1 (enExample)
CL (1) CL2016000944A1 (enExample)
EA (1) EA201690626A1 (enExample)
HK (1) HK1223559A1 (enExample)
IL (1) IL244986A (enExample)
IN (1) IN2013MU03559A (enExample)
MX (1) MX356383B (enExample)
NZ (1) NZ718960A (enExample)
PH (1) PH12016500738A1 (enExample)
SG (1) SG11201603142YA (enExample)
TW (1) TWI579003B (enExample)
WO (1) WO2015075743A1 (enExample)
ZA (1) ZA201602718B (enExample)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RU2599031C1 (ru) * 2015-08-11 2016-10-10 Общество с ограниченной ответственностью "АйВиФарма" Водная композиция рекомбинантного фолликулостимулирующего гормона человека (варианты)
GB201603280D0 (en) 2016-02-24 2016-04-13 Ferring Bv Stable liquid gonadotropin formulation
RU2633079C2 (ru) * 2016-06-21 2017-10-11 Федеральное государственное бюджетное научное учреждение "Центр экспериментальной эмбриологии и репродуктивных биотехнологий" (ФГБНУ ЦЭЭРБ) Фармацевтическая композиция с пролонгированным действием гонадотропинов для проведения индукции суперовуляции у самок млекопитающих
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
CN115634284B (zh) * 2022-10-31 2025-02-11 景泽生物医药(合肥)股份有限公司 一种促性腺激素冻干制剂及其制备方法

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW518235B (en) 1997-01-15 2003-01-21 Akzo Nobel Nv A gonadotropin-containing pharmaceutical composition with improved stability on prolong storage
PL346127A1 (en) * 1998-07-23 2002-01-28 Lilly Co Eli Fsh and fsh variant formulations, products and methods
PT1610822E (pt) * 2003-04-02 2011-01-05 Ares Trading Sa Formulações farmacêuticas líquidas ou liofilizadas de fsh e/ou lh em conjunto com o surfactante não iónico poloxâmero 188 e um agente bacteriostático
KR101105871B1 (ko) * 2005-09-27 2012-01-16 주식회사 엘지생명과학 인 난포자극호르몬의 안정한 용액 제형
WO2008004717A1 (en) * 2006-07-06 2008-01-10 Daewoong Co., Ltd. A stable liquid formulation of human growth hormone
US8329649B2 (en) * 2008-11-04 2012-12-11 Aska Pharmaceutical Co., Ltd. Aqueous composition containing follicle-stimulating hormone and histidine
IT1395957B1 (it) * 2009-05-19 2012-11-02 Pharmaguida S R L Uso di una combinazione di d-aspartato e l-aspartato per il trattamento della infertilita' maschile.
EP2533800B1 (en) * 2010-02-12 2016-07-20 Intas Pharmaceuticals Ltd. Liquid formulation of follicle stimulating hormone
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
US20130121961A1 (en) * 2011-11-11 2013-05-16 The Johns Hopkins University Treatment modalities to prevent or treat loss of cardiovascular function in aging humans

Also Published As

Publication number Publication date
MX356383B (es) 2018-05-24
EP3068374A1 (en) 2016-09-21
HK1223559A1 (zh) 2017-08-04
PH12016500738A1 (en) 2016-05-30
JP2016534061A (ja) 2016-11-04
EA201690626A1 (ru) 2016-09-30
AR098386A1 (es) 2016-05-26
CN105658201A (zh) 2016-06-08
JP6166470B2 (ja) 2017-07-19
IL244986A0 (en) 2016-05-31
SG11201603142YA (en) 2016-05-30
NZ718960A (en) 2017-06-30
TWI579003B (zh) 2017-04-21
CA2928311A1 (en) 2015-05-28
AU2014351326B2 (en) 2017-08-31
CL2016000944A1 (es) 2016-11-11
TW201529097A (zh) 2015-08-01
ZA201602718B (en) 2017-06-28
KR20160048227A (ko) 2016-05-03
IL244986A (en) 2016-11-30
MX2016005154A (es) 2016-08-17
AU2014351326A1 (en) 2016-05-12
US20160250295A1 (en) 2016-09-01
WO2015075743A1 (en) 2015-05-28
KR101699677B1 (ko) 2017-01-24
AP2016009159A0 (en) 2016-04-30

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