HRP20240034T1 - Liječenje kardiovaskularnih bolesti - Google Patents

Liječenje kardiovaskularnih bolesti Download PDF

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Publication number
HRP20240034T1
HRP20240034T1 HRP20240034TT HRP20240034T HRP20240034T1 HR P20240034 T1 HRP20240034 T1 HR P20240034T1 HR P20240034T T HRP20240034T T HR P20240034TT HR P20240034 T HRP20240034 T HR P20240034T HR P20240034 T1 HRP20240034 T1 HR P20240034T1
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HR
Croatia
Prior art keywords
medicine
use according
pharmaceutically acceptable
acceptable salts
dose
Prior art date
Application number
HRP20240034TT
Other languages
English (en)
Inventor
Victor Chengwei Shi
Martin Lefkowitz
Adel Remond RIZKALA
Original Assignee
Novartis Ag
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=51494327&utm_source=***_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20240034(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from PCT/US2013/056680 external-priority patent/WO2015030711A1/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of HRP20240034T1 publication Critical patent/HRP20240034T1/hr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/21Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225Polycarboxylic acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/401Proline; Derivatives thereof, e.g. captopril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/12Antihypertensives

Claims (12)

1. Lijek, naznačen time, što sadrži a) terapeutski učinkovitu količinu spoja formule [(A1)(A2)](Na)y • x H2O (I) gdje: A1 je S-N-valeril-N-{[2'-(1H-tetrazol-5-il)-bifenil-4-il]-metil}-valin u njegovom anionskom obliku; A2 je etil ester (2R,4S)-5-bifenil-4-il-4-(3-karboksi-propionilamino)-2-metil-pentanske kiseline u njegovom anionskom obliku; Na je natrijev ion; y je 3; i x je 0 do 3; ili b) kombinaciju koja sadrži terapeutski učinkovitu količinu u molarnom omjeru 1:1 (i) valsartana ili njegove farmaceutski prihvatljive soli; i (ii) sakubitrila ili njegove farmaceutski prihvatljive soli, za uporabu u sprečavanju ili odgađanju vremena do prve pojave kardiovaskularne smrti kod ljudskog pacijenta koji pati od kroničnog sistoličkog zatajenja srca sa smanjenom ejekcijskom frakcijom.
2. Lijek za uporabu prema patentnom zahtjevu 1, naznačen time, što pacijent prima osnovni tretman sa stabilnom dozom beta-blokatora.
3. Lijek za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, što lijek sadrži spoj formule (I) koji je trinatrijev [3-((1S,3R)-1-bifenil-4-ilmetil-3-etoksikarbonil-1-butilkarbamoil)propionat-(S)-3'-metil-2'-(pentanoil{2"-(tetrazol-5-ilat)bifenil-4'-ilmetil}amino)butirat]hemipentahidrat (LCZ696).
4. Lijek za uporabu prema patentnom zahtjevu 3, naznačen time, što se lijek daje oralno u dnevnoj dozi koja može doseći 400 mg, uzetoj u jednom ili više odvojenih uzimanja.
5. Lijek za uporabu prema patentnom zahtjevu 4, naznačen time, što se lijek daje oralno u dnevnoj dozi koja može doseći 400 mg, uzetoj u dva odvojena uzimanja (b.i.d.).
6. Lijek za uporabu prema patentnom zahtjevu 4 ili 5, naznačen time, što se lijek daje oralno u početnoj dozi od 100 mg b.i.d. u trajanju od jednog do dva tjedna i nakon toga titriranjem do 200 mg b.i.d.
7. Lijek za uporabu prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, što lijek sadrži kombinaciju koja sadrži terapeutski učinkovitu količinu u molarnom omjeru 1:1 (i) valsartana ili njegove farmaceutski prihvatljive soli; i (ii) sakubitrila ili njegove farmaceutski prihvatljive soli.
8. Lijek za uporabu prema patentnom zahtjevu 7, naznačen time, što se kombinacija treba davati oralno u dva odvojena uzimanja (b.i.d.) po danu, pri čemu svaki unos sadrži 103 mg valsartana, ili njegove farmaceutski prihvatljive soli, i 97 mg sakubitrila, ili njegove farmaceutski prihvatljive soli, po jedinici za doziranje.
9. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva 1 do 8, naznačen time, što pacijent ima najmanje jednu od sljedećih dodatnih karakteristika i) zatajenje srca prema NYHA razredu II, III ili IV, ii) povišenu razinu BNP ili NT-proBNP u plazmi, poželjno BNP u plazmi ≥100 pg/mL (ili NT-proBNP ≥400 pg/mL), još poželjnije BNP u plazmi ≥150 pg/mL ili NT-proBNP ≥600 pg/mL, i ii) smanjenu ejekcijsku frakciju lijeve klijetke (LVEF) od ≤40%.
10. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što pacijent ima smanjenu ejekcijsku frakciju lijeve klijetke (LVEF) od ≤35%.
11. Lijek za uporabu prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time, što je lijek učinkovitiji u sprečavanju ili odgađanju vremena do prve pojave kardiovaskularne smrti kod pacijenata koji pate od kroničnog sistoličkog zatajenja srca sa smanjenom ejekcijskom frakcijom, u usporedbi s enalaprilom primijenjenim dva puta dnevno u dozi od 10 mg.
12. Lijek za uporabu prema patentnom zahtjevu 11, naznačen time, što je lijek najmanje 15% učinkovitiji u sprečavanju ili odgađanju vremena do prve pojave kardiovaskularne smrti od lijeka koji sadrži enalapril primijenjenim dva puta dnevno u dozi od 10 mg.
HRP20240034TT 2013-08-26 2014-08-26 Liječenje kardiovaskularnih bolesti HRP20240034T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
PCT/US2013/056680 WO2015030711A1 (en) 2013-08-26 2013-08-26 New use
US201461972933P 2014-03-31 2014-03-31
EP19202854.6A EP3626270B1 (en) 2013-08-26 2014-08-26 Treatment of cardiovascular diseases

Publications (1)

Publication Number Publication Date
HRP20240034T1 true HRP20240034T1 (hr) 2024-03-29

Family

ID=51494327

Family Applications (2)

Application Number Title Priority Date Filing Date
HRP20240034TT HRP20240034T1 (hr) 2013-08-26 2014-08-26 Liječenje kardiovaskularnih bolesti
HRP20200060TT HRP20200060T1 (hr) 2013-08-26 2020-01-16 Nova uporaba

Family Applications After (1)

Application Number Title Priority Date Filing Date
HRP20200060TT HRP20200060T1 (hr) 2013-08-26 2020-01-16 Nova uporaba

Country Status (15)

Country Link
US (2) US20160213646A1 (hr)
EP (3) EP3626270B1 (hr)
JP (1) JP6097888B2 (hr)
CY (1) CY1122531T1 (hr)
DK (2) DK3038654T3 (hr)
ES (1) ES2767084T3 (hr)
FI (1) FI3626270T3 (hr)
HR (2) HRP20240034T1 (hr)
HU (2) HUE064634T2 (hr)
LT (2) LT3626270T (hr)
PL (2) PL3626270T3 (hr)
PT (2) PT3038654T (hr)
RS (2) RS59816B1 (hr)
SI (2) SI3626270T1 (hr)
WO (1) WO2015028941A1 (hr)

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Publication number Priority date Publication date Assignee Title
US10562866B2 (en) * 2015-02-06 2020-02-18 Mylan Laboratories Limited Amorphous trisodium sacubitril valsartan and a process for the preparation thereof
EP3302460A1 (en) * 2015-05-29 2018-04-11 Novartis AG Sacubitril and valsartan for treating metabolic disease
CN106309388A (zh) * 2015-06-30 2017-01-11 深圳信立泰药业股份有限公司 一种用于心衰治疗的药物组合物及其制备方法
CN107510653A (zh) * 2016-06-17 2017-12-26 常州爱诺新睿医药技术有限公司 一种含有无定型沙库比曲和缬沙坦的固体分散体的药用组合物及其制备方法
WO2017036420A1 (zh) * 2015-09-06 2017-03-09 常州方楠医药技术有限公司 含沙库比曲和缬沙坦的药用组合物及其制备方法
CN106491600A (zh) * 2015-09-06 2017-03-15 常州方楠医药技术有限公司 无定型沙库区比、缬沙坦或其药学上可接受的盐与药用辅料的组合物及其制备方法
WO2017042700A1 (en) * 2015-09-07 2017-03-16 Sun Pharmaceutical Industries Limited Solid forms of valsartan and sacubitril
CN106580908A (zh) * 2015-10-16 2017-04-26 深圳信立泰药业股份有限公司 一种用于心血管疾病治疗的口服制剂及其制备方法
CN105330609B (zh) * 2015-12-07 2017-12-22 南京正大天晴制药有限公司 一种制备lcz696的方法
CN108601741B (zh) * 2016-02-03 2022-05-24 诺华股份有限公司 有机化合物的盖伦制剂
CN106176681A (zh) * 2016-08-25 2016-12-07 泰力特医药(湖北)有限公司 一种抗心脏衰竭药物lcz696口服缓释微丸及其制备方法
WO2019008485A1 (en) 2017-07-06 2019-01-10 Mankind Pharma Ltd FIXED DOSE PHARMACEUTICAL COMPOSITION BASED ON VALSARTAN AND SACUBITRIL
US20210177803A1 (en) 2018-08-23 2021-06-17 Novartis Ag New pharmaceutical use for the treatment of heart failure
WO2020039394A1 (en) 2018-08-24 2020-02-27 Novartis Ag New drug combinations
CA3151788A1 (en) * 2019-09-20 2021-03-25 Jingchao Sun Uses of complex of angiotensin ii receptor antagonist metabolite and nep inhibitor in treating heart failure

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PH30484A (en) 1990-02-19 1997-05-28 Ciba Geigy Acy compounds pharmaceutical composition containing said compound and method of use thereof
US5217996A (en) 1992-01-22 1993-06-08 Ciba-Geigy Corporation Biaryl substituted 4-amino-butyric acid amides
ATE243515T1 (de) * 1997-01-10 2003-07-15 Merck & Co Inc Verwendung der angiotensin ii-antagonisten losartan und exp-3174 zur behandlung von symptomatisches herzversagen
RU2334513C3 (ru) 2002-01-17 2017-10-24 Новартис Аг Фармацевтические композиции, включающие валсартан и ингибиторы нейтральной эндопептидазы (nep)
CA2525665A1 (en) * 2003-05-16 2004-11-25 Novartis Ag Pharmaceutical composition comprising valsartan
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FI3067043T3 (fi) 2007-11-06 2023-03-18 Novartis Ag Angiotensiinireseptoriantagonistin/-salpaajan (arb) ja neutraalin endopeptidaasin (nep) estäjän superrakenteisiin perustuvia farmaseuttisia koostumuksia
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Also Published As

Publication number Publication date
FI3626270T3 (fi) 2024-01-11
JP2016528303A (ja) 2016-09-15
LT3626270T (lt) 2024-01-25
US20160213646A1 (en) 2016-07-28
PT3626270T (pt) 2024-01-11
HRP20200060T1 (hr) 2020-04-03
DK3626270T3 (da) 2024-01-15
DK3038654T3 (da) 2020-02-03
EP3038654B1 (en) 2019-10-30
RS65037B1 (sr) 2024-02-29
CY1122531T1 (el) 2021-01-27
RS59816B1 (sr) 2020-02-28
ES2767084T3 (es) 2020-06-16
HUE047186T2 (hu) 2020-04-28
SI3038654T1 (sl) 2020-02-28
EP3626270A1 (en) 2020-03-25
US20210077461A1 (en) 2021-03-18
WO2015028941A1 (en) 2015-03-05
HUE064634T2 (hu) 2024-04-28
PL3626270T3 (pl) 2024-04-08
JP6097888B2 (ja) 2017-03-15
EP3038654A1 (en) 2016-07-06
LT3038654T (lt) 2020-01-27
EP3626270B1 (en) 2023-10-11
EP4321157A2 (en) 2024-02-14
EP4321157A3 (en) 2024-05-15
PT3038654T (pt) 2020-02-04
PL3038654T3 (pl) 2020-05-18
SI3626270T1 (sl) 2024-03-29

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