HRP20230075T1 - Čvrsti pripravci namijenjeni oralnoj primjeni - Google Patents

Čvrsti pripravci namijenjeni oralnoj primjeni Download PDF

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Publication number
HRP20230075T1
HRP20230075T1 HRP20230075TT HRP20230075T HRP20230075T1 HR P20230075 T1 HRP20230075 T1 HR P20230075T1 HR P20230075T T HRP20230075T T HR P20230075TT HR P20230075 T HRP20230075 T HR P20230075T HR P20230075 T1 HRP20230075 T1 HR P20230075T1
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HR
Croatia
Prior art keywords
ethoxy
acetyl
amino
preparation
glp
Prior art date
Application number
HRP20230075TT
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English (en)
Inventor
Andreas VEGGE
Susanne SCHÉELE
Simon Bjerregaard
Original Assignee
Novo Nordisk A/S
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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Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=59070439&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20230075(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of HRP20230075T1 publication Critical patent/HRP20230075T1/hr

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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
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • 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
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7028Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
    • A61K31/7034Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/04Anorexiants; Antiobesity agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Claims (15)

1. Čvrsti pripravak namijenjen oralnoj primjena, naznačen time što sadrži derivat GLP-1 i dapagliflozin, gdje se navedeni derivat GLP-1 bira iz skupine koju čine a. semaglutid, b. Nε26-{2-[2-(2-{2-[2-(2-{(S)-4-karboksi-4-[10-(4-karboksifenoksi)dekanoilamino]butirilamino}etoksi)etoksi]acetilamino}etoksi)etoksi]acetil},Nε37-{2-[2-(2-{2-[2-(2-{(S)-4-karboksi-4-[10-(4-karboksifenoksi)dekanoilamino]butirilamino}etoksi)etoksi]acetilamino}etoksi)etoksi]acetil}-[Aib8,Arg34,Lys37]GLP-1(7-37)-peptid [image] c. Nε27-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[10-(4-karboksifenoksi)dekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil],Nε36-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[10-(4-karboksifenoksi)dekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil]-[Aib8,Glu22,Arg26,Lys27,Glu30,Arg34,Lys36]-GLP-1-(7-37)-peptidil-Glu-Gly [image] d. Nε36-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[11-(4-karboksifenoksi)undekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil],Nε37-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[11-(4-karboksifenoksi)undekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil]-[Aib8,Glu22,Arg26,Arg34,Lys36,Lys37]-GLP-1-(7-37)-peptid [image] e. Nε36-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[11-(4-karboksifenoksi)undekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil],Nε37-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[11-(4-karboksifenoksi)undekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil]-[Aib8,Arg26,Arg34,Lys36,Lys37]-GLP-1-(7-37)-peptid [image] te f. Nε36-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[10-(3-karboksifenoksi)dekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil],Nε37-[2-[2-[2-[[2-[2-[2-[[(4S)-4-karboksi-4-[10-(3-karboksifenoksi)dekanoilamino]butanoil]amino]etoksi]etoksi]acetil]amino]etoksi]etoksi]acetil]-[Aib8,Glu22,Arg26,Arg34,Lys36,Lys37]-GLP-1-(7-37)-peptid [image]
2. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je navedeni derivat GLP-1 semaglutid.
3. Pripravak u skladu s patentnim zahtjevom 1, naznačen time što je navedeni derivat GLP-1 Spoj B.
4. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak dodatno sadrži sredstvo za poboljšavanje apsorpcije.
5. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeno sredstvo za poboljšavanje apsorpcije sol NAC.
6. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeno sredstvo za poboljšavanje apsorpcije SNAC.
7. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni derivat GLP-1 i/ili dapagliflozin u obliku farmaceutski prihvatljive soli, estera ili solvata.
8. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak sadrži 5-300 mg dapagliflozina, 20-800 mg soli NAC, primjerice SNAC, te izborno 0,1-100 mg derivata GLP-1.
9. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što doziranje navedenog dapagliflozina je 0,5-50 mg dnevno, a doziranje navedenog derivata GLP-1 je 0,1-100 mg dnevno.
10. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što navedeni pripravak sadrži jedno ili više dodatnih farmaceutski prihvatljivih pomoćnih sredstava.
11. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je navedeni pripravak u obliku tablete, kapsule ili vrećice.
12. Pripravak u skladu s bilo kojim od prethodnih patentnih zahtjeva, naznačen time što je namijenjen upotrebi u medicini.
13. Pripravak u skladu s patentnim zahtjevom 12, naznačen time što je namijenjen upotrebi u liječenju dijabetesa tipa 2.
14. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 12 ili 13, naznačen time što je primijenjeno doziranje navedenog pripravka u rasponu od 200-1000 mg.
15. Pripravak namijenjen upotrebi u skladu s bilo kojim od patentnih zahtjeva 12-14, naznačen time što se navedeni pripravak primjenjuje jednom dnevno.
HRP20230075TT 2017-06-09 2018-06-11 Čvrsti pripravci namijenjeni oralnoj primjeni HRP20230075T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17175131 2017-06-09
EP18730344.1A EP3634468B1 (en) 2017-06-09 2018-06-11 Solid compositions for oral administration
PCT/EP2018/065266 WO2018224689A2 (en) 2017-06-09 2018-06-11 Solid compositions for oral administration

Publications (1)

Publication Number Publication Date
HRP20230075T1 true HRP20230075T1 (hr) 2023-03-17

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HRP20230075TT HRP20230075T1 (hr) 2017-06-09 2018-06-11 Čvrsti pripravci namijenjeni oralnoj primjeni

Country Status (28)

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US (2) US11167014B2 (hr)
EP (1) EP3634468B1 (hr)
JP (1) JP7239495B2 (hr)
KR (1) KR20200015564A (hr)
CN (1) CN110769846A (hr)
AR (1) AR112015A1 (hr)
AU (1) AU2018280875A1 (hr)
BR (1) BR112019025769A2 (hr)
CA (1) CA3064677A1 (hr)
CL (1) CL2019003402A1 (hr)
CO (1) CO2019013047A2 (hr)
DK (1) DK3634468T3 (hr)
ES (1) ES2938050T3 (hr)
FI (1) FI3634468T3 (hr)
HR (1) HRP20230075T1 (hr)
HU (1) HUE060962T2 (hr)
IL (1) IL270812B2 (hr)
MA (1) MA49253A (hr)
MX (1) MX2019013965A (hr)
MY (1) MY197488A (hr)
PE (1) PE20200606A1 (hr)
PH (1) PH12019550249A1 (hr)
PL (1) PL3634468T3 (hr)
PT (1) PT3634468T (hr)
RS (1) RS64045B1 (hr)
SI (1) SI3634468T1 (hr)
TW (1) TWI797133B (hr)
WO (1) WO2018224689A2 (hr)

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PE20200606A1 (es) 2020-03-10
CO2019013047A2 (es) 2020-04-01
RU2019139082A (ru) 2021-06-02
DK3634468T3 (da) 2023-02-06
JP2020522559A (ja) 2020-07-30
MY197488A (en) 2023-06-19
TW201904583A (zh) 2019-02-01
PL3634468T3 (pl) 2023-03-13
IL270812A (en) 2020-01-30
PH12019550249A1 (en) 2020-07-13
WO2018224689A2 (en) 2018-12-13
HUE060962T2 (hu) 2023-04-28
CN110769846A (zh) 2020-02-07
IL270812B2 (en) 2024-01-01
MX2019013965A (es) 2020-01-23
IL270812B1 (en) 2023-09-01
WO2018224689A3 (en) 2019-02-28
AU2018280875A1 (en) 2019-12-12
US11167014B2 (en) 2021-11-09
ES2938050T3 (es) 2023-04-04
RU2019139082A3 (hr) 2021-09-16
MA49253A (fr) 2020-04-15
TWI797133B (zh) 2023-04-01
JP7239495B2 (ja) 2023-03-14
US20200147179A1 (en) 2020-05-14
EP3634468A2 (en) 2020-04-15
FI3634468T3 (fi) 2023-02-19
BR112019025769A2 (pt) 2020-06-30
KR20200015564A (ko) 2020-02-12
SI3634468T1 (sl) 2023-02-28
EP3634468B1 (en) 2022-12-14
PT3634468T (pt) 2023-03-28
RS64045B1 (sr) 2023-04-28
US20220016216A1 (en) 2022-01-20
CA3064677A1 (en) 2018-12-13
AR112015A1 (es) 2019-09-11
CL2019003402A1 (es) 2020-03-20

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