HRP20120004T4 - Inhibitori dipeptidil peptidaze za lijeäśenje dijabetesa - Google Patents

Inhibitori dipeptidil peptidaze za lijeäśenje dijabetesa Download PDF

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HRP20120004T4
HRP20120004T4 HRP20120004TT HRP20120004T HRP20120004T4 HR P20120004 T4 HRP20120004 T4 HR P20120004T4 HR P20120004T T HRP20120004T T HR P20120004TT HR P20120004 T HRP20120004 T HR P20120004T HR P20120004 T4 HRP20120004 T4 HR P20120004T4
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pharmaceutical composition
composition according
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dosage form
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Ronald J. Christopher
Paul Covington
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Takeda Pharmaceutical Company Limited
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic 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
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic 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
    • A61K31/425—Thiazoles
    • A61K31/426—1,3-Thiazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/26—Glucagons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/14—Antivirals for RNA viruses
    • A61P31/18—Antivirals for RNA viruses for HIV
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/48—Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50—Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Endocrinology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Biophysics (AREA)
  • Obesity (AREA)
  • Virology (AREA)
  • Hematology (AREA)
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  • AIDS & HIV (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Plural Heterocyclic Compounds (AREA)
  • Medicinal Preparation (AREA)

Claims (45)

1. Farmaceutska kompozicija formulirana u pojedinačnom doznom obliku, pri čemu takav pojedinačni dozni oblik sadrži između 1 mg i 250 mg spoja I, pri čemu spoj I ima formulu [image]
2. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži između 5 mg i 200 mg spoja I.
3. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži između 5 mg i 150 mg spoja I.
4. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži između 15 mg i 100 mg spoja 1.
5. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži 5 mg spoja I.
6. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži 6.25 mg spoja I.
7. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time e što takav pojedinačni dozni oblik sadrži 10 mg spoja I.
8. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži 20 mg spoja I.
9. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži 25 mg spoja I.
10. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadrži 50 mg spoja I.
11. Farmaceutska kompozicija prema patentnom zahtjevu 1, naznačena time što takav pojedinačni dozni oblik sadr/i 100 mg spoja 1.
12. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-11, naznačena time što takav pojedinačni dozni oblik dalje sadrži jedan ili više antidijabetičkih spojeva koji se razlikuju od spoja I.
13. Farmaceutska kompozicija formulirana u obliku pojedinačne doze, naznačena time što takav pojedinačni dozni oblik sadrži između 1 mg i 250 mg spoja I i jedan ili više antidijabetičkih spojeva koji se razlikuju od spoja I, pri čemu spoj I ima formulu [image]
14. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičkih sredstava koji su izabrani iz grupe koju čine modulatori puta prijenosa signala insulina, spoja koji utječe na disreguliranu proizvodnju glukoze u jetri, pojačivači osjetljivosti na insulin i pojačivači izlučivanja insulina.
15. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13. naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičnih spojeva koji su izabrani iz grupe koju čine inhibitori protein tirozin fosfataze, inhibitori glutamin-fruktoza-6-fosfat amidotransferaze, inhibitori glukoza-6-fosfataze, inhibitori fruktoza-1,6-bisfosfataze, inhibitori glikogen fosforilaze, antagonisti receptora za glukagon, inhibitori fosfoenolpiruvat karboksikinaze. inhibitori piruvat dehidrogenaza kinaze, inhibitori alfa-glukozidaze. inhibitori pražnjenja želuca, insulin i α2-adrenergični antagonisti.
16. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedno ili više antidijabetičkih sredstava izabranih iz grupe koju čine inhibitori GSK-3, agonisti receptora za retinoid X, agonisti Beta-3 AR, modulatori UCP, antidijabetički tiazolidindioni, ne-glitazon tip agonisti PPAR gama, dvostruki PPAR gama/PPAR alfa agonisti, antidijabetički spojevi koji sadrže vanadij i biguanidi.
17. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičnih spojeva izabranih iz grupe koju čine (S)-((3,4-dihidro-2-(fenil-metil)-2H-1-benzopiran-6-il)metil-tiazolidin-2,4-dion, 5-{[4-(3-(5-metil-2-fenil-4-oksazolil)-1-okso-propil)-fenil]-metil}-tiazolidin-2,4-dion, 5-{[4-(1-metil-cikloheksil)metoksi)-fenil]metil]-tiazolidin-2,4-dion, 5-{[4-(2-(1-indolil) etoksi)fenil]metil}-tiazolidin-2,4-dion, S-{4-[2-(5-metil-2-fenil-4-oksazolil)-etoksi)]benzil}-tiazolidin -2,4-dion, 5-(2-naftilsulfonil)-tiazolidin-2,4-dion, bis(4-[(2,4-diokso-5-tiazolidinil)-metil|fenil}metan. 5-{4-(2-(5-metil-2-fenil-4-oksazolil)-2-hidroksieloksi]-benzil}-tiazolidin-2,4-dion, 5-[4-(l-fenil-1-ciklo propan karbonil amino)-benzil]-tiazolidin-2,4-dion, S-{[4-(2-(2,3-dihidroindol-1-il)etoksi)fenilmetil)-tiazolidin-2,4-dion, 5-[3-(4-kloro-fenil])-2-propinil]-5-fenilsulfonil)tiazolidin-2,4-dion, 5-[3-(4-klorofenil])-2-propinil]-5-(4-fluorofenil-sulfo nil)tiazolidin-2,4-dion, 5-{[4-(2-(metil-2-piridinil-amino)-etoksi)fenil]metil}-tiazolidin-2,4-dion, 5-([2-(2-naful)-benzoksazol-5-il]-metil}tiazolidin-2,4-dion i 5-(2,4-dioksotiazolidin-5-ilmetil)-2-metoksi-N-(4-trifluoro metil-benzil)benzamid, uključujući sve njihove farmaceutski prihvatljive soli.
18. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži metformin, uključujući sve njegove farmaceutski prihvatljive soli.
19. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži derivat sulfonil uree.
20. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičkih spojeva izabranih iz grupe koju čine glisoksepid, gliburid, glibenklamid, acetoheksamid, kloropropamid, glibornurid, tolbutamid, tolazamid, glipizid, karbutamid, glikvidon, gliheksamid, fenbutamid, tolciklamid, glimepirid i gliklazid, uključujući sve njihove farmaceutski prihvatljive soli.
21. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičkih spojeva izabranih iz grupe koju čine inkretin hormoni ili spojevi koji ga imitiraju, antagonisti receptom za imidazolin beta stanica i insulinski sekretagogi sa kratkim djelovanjem.
22. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-12, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antagonista GLP-1.
23. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni do/ni oblik sadrži ekstendatid.
24. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičkih spojeva izabranih iz grupe koju čine repaglinid, mitiglinid i nateglinid, uključujući sve njihove farmaceutski prihvatljive soli.
25. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni do/ni oblik sadrži jedan ili više inhibitora alfa-Glukozidaze.
26. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži jedan ili više antidijabetičnih spojeva izabranih iz grupe koju čine akarboza, vogliboza i miglitol, uključujući sve njihove farmaceutski prihvatljive soli.
27. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži rosiglitazon, uključujući sve njegove farmaceutski prihvatljive soli.
28. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-13, naznačena time što takav pojedinačni dozni oblik sadrži pioglitazon, uključujući sve njegove farmaceutski prihvatljive soli.
29. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-28, naznačena time što je takav pojedinačni dozni oblik prilagođen za oralnu primjenu.
30. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-28, naznačena time što je takav pojedinačni dozni oblik čvrsta formulacija prilagođena za oralnu primjenu.
31. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-28, naznačena time što je takav pojedinačni dozni oblik tableta ili kapsula prilagođena za oralnu primjenu.
32. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-28, naznačena time što takav pojedinačni dozni oblik sadrži formulaciju sa produženim oslobađanjem prilagođenu za oralnu primjenu.
33. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-32, naznačena time što je spoj I prisutan u farmaceutskoj kompoziciji kao slobodna baza.
34. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-32, naznačena time što je spoj I prisutan u farmaceutskoj kompoziciji u farmaceutski prihvatljivoj soli.
35. Farmaceutska kompozicija prema bilo kojem od patentnih zahtjeva 1-32, naznačena time što je spoj I prisutan u farmaceutskoj kompoziciji u sukcinatnoj soli.
36. Komplet koji sadrži: višestruke doze farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35; i uputstva koja sadrže jedan ili više oblika informacija izabranih iz grupe koju čine indikacija stanja bolesti za koju se primjenjuje farmaceutska kompozicija, informacije o čuvanju za farmaceutsku kompoziciju, informacije o doziranju i uputstva u svezi s tim kako primjenjivati farmaceutsku kompoziciju.
37. Proizvodni artikl koji sadrži: višestruke doze farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35; i materijale za pakovanje.
38. Proizvodni artikl prema patentnom zahtjevu 37, naznačen time što materijal za pakovanje sadrži kontejner za smještaj višestrukih doza farmaceutske kompozicije.
39. Proizvodni artikl prema patentnom zahtjevu 38, naznačen time što kontejner sadrži etiketu koja ukazuje na jednog ili više članova grupe koju čine stanje bolesti za koju se spoj primjenjuje, informacije o čuvanju, informacije o doziranju i/ili uputstva vezana za to kako primjenjivati kompoziciju.
40. Uporaba farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 u kombinaciji sa jednim ili više antidijabetičnih spojeva koji se razlikuju od spoja I za proizvodnju lijeka za liječenje dijabetesa tipa II, pri čemu spoj I ima formulu [image]
41. Uporaba farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 za proizvodnju lijeka koji sadrži kombinaciju spoja I i jednog ili više antidijabetičkih spojeva koji se razlikuju od spoja I za liječenje dijabetesa tipa II, pri čemu spoj I ima formulu [image]
42. Uporaba jednog ili više antidijabetičkih spojeva koji se razlikuju od spoja I za proizvodnju lijeka koji sadrži kombinaciju farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 i jednog ili više antidijabetičkih spojeva koji se razlikuju od spoja I za liječenje dijabetesa tipa II, pri čemu spoj I ima formulu [image]
43. Uporaba farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 u kombinaciji sa jednim ili više antidijabetičkih spojeva koji se razlikuju od spoja I za proizvodnju lijeka za liječenje dijabetesa tipa I, pri čemu spoj I ima formulu [image]
44. Uporaba farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 za proizvodnju lijeka koji sadrži kombinaciju spoja I i jednog ili više antidijabetičkih spojeva koji se razlikuju od spojeva I za liječenje dijabetesa tipa I, pri čemu spoj I ima formulu [image]
45. Uporaba jednog ili više antidijabetičnih spojeva koji se razlikuju od spoja I za proizvodnju lijeka koji sadrži kombinaciju farmaceutske kompozicije prema bilo kojem od patentnih zahtjeva 1-35 i jednog ili više antidijabetičnih spojeva koji se razlikuju od spoja I za liječenje dijabetesa tipa I. pri čemu spoj I ima formulu [image] .
HRP20120004TT 2005-09-14 2006-09-13 Inhibitori dipeptidil peptidaze za lijeäśenje dijabetesa HRP20120004T4 (hr)

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Application Number Priority Date Filing Date Title
US71756005P 2005-09-14 2005-09-14
US74728006P 2006-05-15 2006-05-15
PCT/US2006/035958 WO2007033350A1 (en) 2005-09-14 2006-09-13 Dipeptidyl peptidase inhibitors for treating diabetes

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HRP20120004T1 HRP20120004T1 (hr) 2012-03-31
HRP20120004T4 true HRP20120004T4 (hr) 2014-06-06

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US (3) US20070060530A1 (hr)
EP (1) EP1942898B2 (hr)
JP (1) JP5027137B2 (hr)
KR (1) KR101345316B1 (hr)
CN (1) CN101374523B (hr)
AR (1) AR055435A1 (hr)
AT (1) ATE532518T1 (hr)
AU (1) AU2006290205B2 (hr)
CA (1) CA2622472C (hr)
CR (1) CR9874A (hr)
CY (1) CY1112281T1 (hr)
DK (1) DK1942898T4 (hr)
EA (1) EA015169B1 (hr)
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PT1931350E (pt) 2005-09-14 2014-02-12 Takeda Pharmaceutical Administração de inibidores de dipeptidil peptidase
PE20070622A1 (es) 2005-09-14 2007-08-22 Takeda Pharmaceutical Administracion de inhibidores de dipeptidil peptidasa
TW200745079A (en) 2005-09-16 2007-12-16 Takeda Pharmaceuticals Co Polymorphs of benzoate salt of 2-[[6-[(3R)-3-amino-1-piperidinyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-benzonitrile and methods of use therefor

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