(19)
(11) EP 4 770 620 A1

(12)

(43) Date of publication:
08.07.2026 Bulletin 2026/28

(21) Application number: 24772865.2

(22) Date of filing: 30.08.2024
(51) International Patent Classification (IPC): 
A61K 9/14(2006.01)
A61K 31/404(2006.01)
 A61K 9/16(2006.01)
A61P 43/00(2006.01)
(52) Cooperative Patent Classification (CPC):
A61K 9/146; A61K 9/1652; A61K 9/1635; A61K 9/1694; A61P 43/00; A61K 31/404
(86) International application number:
PCT/US2024/044702
(87) International publication number:
WO 2025/049929 (06.03.2025 Gazette 2025/10)
(84) Designated Contracting States:
AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC ME MK MT NL NO PL PT RO RS SE SI SK SM TR
Designated Extension States:
BA
Designated Validation States:
GE KH MA MD TN

(30) Priority: 31.08.2023 US 202363535854 P
31.08.2023 US 202363535864 P
26.10.2023 US 202363593495 P
01.03.2024 US 202463560597 P
01.03.2024 US 202463560598 P

(71) Applicant: BioMarin Pharmaceutical Inc.
Novato, CA 94949 (US)

(72) Inventors:
  • AGARWAL, Suresh, Kumar
    Novato, CA 94949 (US)
  • BATTU, Sunil
    Novato, CA 94949 (US)
  • CHOU, Tian, Wei
    Novato, CA 94949 (US)
  • HANDYSIDE, Britta
    Novato, CA 94949 (US)
  • TRANTCHEVA, Iva, Darieva
    Novato, CA 94949 (US)
  • WENZEL, Heather Ann
    Novato, CA 94949 (US)
  • CLIKEMAN, Tyler
    Bend, OR 97703 (US)
  • COKER, Bailey
    Bend, OR 97703 (US)
  • DUROSS, Allison
    Bend, OR 97703 (US)
  • SATHER, Craig
    Bend, OR 97703 (US)

(74) Representative: Jones Day 
Gewürzmühlstr. 11
80538 München
80538 München (DE)

   


(54) DOSAGE FORMS OF N-(1-(2-CHLORO-3-FLUOROPHENYL)-1-HYDROXYPENTAN-2-YL)-7-FLUORO-2-OXOINDOLINE-4-CARBOXAMIDE AND METHODS OF THEIR PREPARATION AND USE