HUE025355T2 - Kompozíció pulmonáris hipertensio kezeléséhez - Google Patents

Kompozíció pulmonáris hipertensio kezeléséhez Download PDF

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Publication number
HUE025355T2
HUE025355T2 HUE07855065A HUE07855065A HUE025355T2 HU E025355 T2 HUE025355 T2 HU E025355T2 HU E07855065 A HUE07855065 A HU E07855065A HU E07855065 A HUE07855065 A HU E07855065A HU E025355 T2 HUE025355 T2 HU E025355T2
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HU
Hungary
Prior art keywords
ambrisentan
subjects
placebo
pah
baseline
Prior art date
Application number
HUE07855065A
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English (en)
Inventor
Michael J Gerber
Christopher Dufton
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Gilead Sciences Inc
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.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39092031&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HUE025355(T2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Gilead Sciences Inc filed Critical Gilead Sciences Inc
Publication of HUE025355T2 publication Critical patent/HUE025355T2/hu

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    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/53Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • 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

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  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Pulmonology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Claims (7)

  1. SZABADALMI IGÉNYPONTOK
    1. Roíí's'íOííWíí, y iaataint«;;: sstibdsemant íelbassnalaasa pul-nenavia bipss'iestsix? állapot kesdéxdv alanyban annak ierapiásan batasos n:e;nvyl.segenek adagolása te ed; sx alany szántása, akis a bázis vonalon, az akn-ybd; állapot elO dnsgsibexaeak ídtgétol számított idő sem több, ntln- 2 év és aböl a? andxn.emsn kontbínádbs lesaoiábaa tan adagolva Ibszbxbesstes'áz-á (PDES) bsbíbltoival, amely k; va:n választva stláenaill, taáalatn és vatiieitatíl közül.
  2. 2, .Az 1. igém pom szei'lnb kompozíok;, öböl az alanynak axtanö a da go la skov. az alany tapasztana & következők legalább egyikét: (aj egy vagy Óbb heuxdinannkai ·χη:κ·χ·ηχ boseátgaebása, asnetyek a polnexenx hipenensio állapot javulását ;m;l:abák a normáikhoz kbedebh: sein; ide a bank; vonalhoz kcgest (bí lesé tebeaitöképességjaviilásáí a báessvoitalbo® képest; (el Bevy dyspeog Index IBDI} esokkeoéseí a: báxov Ondiam képest: (di) egy vagy több éisímivtöség pasamét;·:?' ja válását a bázisvomsShiXZ képest; éstvagy (e) mozgás; a;?x sonyabb WHO binkdboszlálybs, 2. .A.;.· j. vagy 2. ményposn szerinti kösnposvoiö telbimznátásra, aboi se alanynak iöiténö saiagotás niât! a közepes eákbinéik; ayovnás (PAP) legalább5 Hg mm· el csökkent, előnyöseit legalább .5 Hyonmrl. a feázisvonallíos képest. 4. Λ.··: í-s Igénypoítívvk bámtelytke szerinti: kovopozido ielltaszsiálásm, ahol az aJaityaak adéne adagolás alán a mér; lest: teljesítőképesség lavvtfe legalább Itt m-el eibityősert legalább 2(1 in ö pettes jáitbávolaágban íbM WD; ;
  3. 5. Az 1-4. igénypontok bévsaeh Ike szentsti kompozíció lelhasználasra, ahol a>·. alanynak történő adagolás étén, BDI : sokkévá legalább 0,5 bxlexponttal, e lee Aden legalább 1 index ponttal, a bázisvonalboz képest, ö. As I··::·. tgénypomd; ItámveKske szedné kompozteiő tetlsisznátásra, als4 a bázisvemdost az alany állapotának dsö díagnödsa étán az «bt nets több, iráni 0.5 év.
  4. 7. Az l-é. igénypontok báoneiyike szerinti kompozíció lelhasználásm, «hol a poimonans lépertenslo állapét tartalmas pábnonads artériás liiperiea:n<a (PAH). b. A ?. méoypo-x szentül kosnpozaáö Izobassnáissra, ahol a FAJI bas 1st tava len legalább WHO II. osztályban van.
  5. 9, A k, igénypont szedni! kompozlotö mibasználásra, akit as alanynak van a bázlsvonaton s következők közűi legalább egy, előnyösen as basses ; isi közepes PAP: legalább 25 .l!y.n;m ityngalesebas vagy legalább ab Hgnttn lesd igénybevételnél, (b) paknonasls vaseetaids sezisziendn (PVRt legalálát 3 llgnmPl.Wm. ésA'agy (el pdmonzris kapilláris eOaovIás; nyomás (PCWP) vagy bdka:ora végillaszlalés nyonvás (i.A'PDP) nenv nap yobb. iráni 15 iigntnt. U.s. â S. igoovgeas amuk; kswpozsvk klba vassá Ossa, a hei síz eianyssak ;í bázkvosssss közepes oysxgako PAP éneke legalább körulbehl; 40 i -pneu ; I. Λ>·: j-IÖ, igslnypaatefc bármelyike vzssrksd k>r;;posbvih bsshaveMOsra, sshol az ieskrisereae cs a PDlïS inbsböer •••»ráhvass vae astssgolva egyszsa· rísípsvsía. ! 1 As: ML igenypsaosb, bssnvehase szeresd kossaxedess! klbssezssiibbns, aboi se ss-nbosesXssx zaps ; psg - 2 S mg bsksebssv, donyeeea 2.S as;.·: - i b svg sbksabssíi s en ssdagskv«,
  6. 13. Ae 1Ί2, iaessyprasSek ixevielyske sZssnxb ksxsspozíek hbb;s\zsdii;ksii. sslsel ;s:e sssvbsbvnex; és a PDE5 ssshibkx legsbabb; egy Olssug ko/escsi idikssztasvbass, ebxsyöseo: kg&amp;isbk bárom bóssxpbssrs vas adagéba.
  7. 14. Ae MB. igsksypossrek bármelyike szobás; kmvpoelcbl se!;sssesaia\ra. aha; a goavoisáiiss alperíessse adages WHO: 20 oaopostokasrs vass Oísszzályozva, 15. A 14, sgéayposx széna·; k;x;xv>zxao klkssersalsbra, aboi ass átlapoz ssszmlmaz balokba; pb vas' vagy Basez selvbosegiségeí éd vagy batsdsMl val vasári:·; seBbaiegsséget lb. A 14 vagy 15. OöaypeaS szénád BxrspozMó IcihsezoaBara. alsói az álkaxss ksspesobkdk egylsez vagy sëbbbôg a köve;kezek közül: kssksrhse zxssüzsküv gabssossan.s beSegsdg CCObOy bkezsboiálB Ibsbibeksgeeg, alvászavarra légzés. Hveelasix blpisysissblàvlèa zavar, nagy asagasságoek sönesso kozokaz káé soi, de Odes: svobelleeessivz. pcozzysssbs és/vagy stHsálb; pubeonsev; anasvsk íbsvmbssesszboSiyrss obsdzskvldia, ssesss sksssssixstlkas pabaosHkP essbxsba. ·<;;:νοΙ·1ο:>;\. bszsmebosis X. lyîriphassgloszsamvb, ez-oagy bldooM·· i-omprsmzzax;·. !?, A:e 10 b. sgévygosssek bkrsveb ik; aeesiski kunspozieib lelhazzsBkivra, ahoi az asx-brOeovu; adssgssllxa egy he ras pars belad eldssyoeva egy hdless bolkl kezsibbik sr-og a ilsagooriz avas;
HUE07855065A 2006-12-12 2007-12-11 Kompozíció pulmonáris hipertensio kezeléséhez HUE025355T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US86966706P 2006-12-12 2006-12-12

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HUE07855065A HUE025355T2 (hu) 2006-12-12 2007-12-11 Kompozíció pulmonáris hipertensio kezeléséhez
HUS1600027C HUS1600027I1 (hu) 2006-12-12 2016-05-20 Kompozíció pulmonáris hipertensio kezeléséhez

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Country Link
US (7) US20080139593A1 (hu)
EP (2) EP2952193A1 (hu)
JP (1) JP2010512414A (hu)
AU (1) AU2007333115B2 (hu)
CA (1) CA2669536C (hu)
CY (1) CY2016017I2 (hu)
DK (1) DK2101777T3 (hu)
ES (1) ES2544724T3 (hu)
HK (1) HK1218393A1 (hu)
HU (2) HUE025355T2 (hu)
LU (1) LU93081I2 (hu)
PL (1) PL2101777T3 (hu)
PT (1) PT2101777E (hu)
SI (1) SI2101777T1 (hu)
WO (1) WO2008073928A1 (hu)

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* Cited by examiner, † Cited by third party
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PT2101777E (pt) 2006-12-12 2015-09-18 Gilead Sciences Inc Composição para tratar uma hipertensão pulmonar
AU2008275179B2 (en) 2007-07-11 2013-09-12 Lexicon Pharmaceuticals, Inc. Methods and compositions for treating pulmonary hypertension and related diseases and disorders
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SI2637664T1 (sl) * 2010-10-15 2017-07-31 Gilead Sciences, Inc. Sestavki in postopki zdravljenja pljučne hipertenzije
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US20130225595A1 (en) * 2012-02-29 2013-08-29 Gilead Sciences, Inc. Method for treating pulmonary arterial hypertension in a patient not having idiopathic pulmonary fibrosis
US20130224306A1 (en) * 2012-02-29 2013-08-29 Gilead Sciences, Inc. Method for treating a pulmonary hypertension condition without companion diagnosis
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Publication number Publication date
US9993475B2 (en) 2018-06-12
CA2669536A1 (en) 2008-06-19
US20150224100A1 (en) 2015-08-13
DK2101777T3 (en) 2015-08-17
HUS1600027I1 (hu) 2016-06-28
US9474752B2 (en) 2016-10-25
WO2008073928A1 (en) 2008-06-19
US8377933B2 (en) 2013-02-19
EP2101777A1 (en) 2009-09-23
LU93081I2 (fr) 2016-07-20
SI2101777T1 (sl) 2015-08-31
ES2544724T3 (es) 2015-09-03
EP2952193A1 (en) 2015-12-09
CY2016017I1 (el) 2016-10-05
US20100152217A1 (en) 2010-06-17
CY2016017I2 (el) 2016-10-05
US20130116257A1 (en) 2013-05-09
US20080139593A1 (en) 2008-06-12
US20170136016A1 (en) 2017-05-18
AU2007333115B2 (en) 2013-01-10
PT2101777E (pt) 2015-09-18
HK1218393A1 (zh) 2017-02-17
PL2101777T3 (pl) 2015-10-30
AU2007333115A1 (en) 2008-06-19
US20140296244A1 (en) 2014-10-02
US9504685B2 (en) 2016-11-29
EP2101777B1 (en) 2015-05-20
JP2010512414A (ja) 2010-04-22
US20110245253A1 (en) 2011-10-06
CA2669536C (en) 2016-05-31

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