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  1. pharmadog
  2. ›drugs
  3. ›Duvyzat
drug · small molecule
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givinostat hydrochloride

Marketedupdated 3mo ago
by Italfarmaco SpA🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for duchenne muscular dystrophy and 1 investigational indication.

indications

investigational
Duchenne Muscular Dystrophy

targets

Histone deacetylase

all catalysts(0)

nothing on the calendar yet

Trials studying givinostat hydrochloride

  • phase2Pharmacokinetics and Safety of Givinostat in DMD Patients Ages From at Least 2 Years to Less Then 6 Years Oldrecruitingn=18

Patent cliff

source: FDA Orange Book
first barrier falls
Jan 15, 2027
157 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (4)

  • Oct 28, 2036formulationUS 10688047
  • Feb 3, 2032method-of-use (U-3885)US 9421184
  • Feb 3, 2032method-of-use (U-3885)US 9867799
  • Jan 15, 2027compositionUS 7329689157d

FDA exclusivities (2)

  • Mar 21, 2031ODE-473Orphan Drug (7y)4.6y
  • Mar 21, 2029NCENew Chemical Entity (5y)2.6y

News(0)

no news has mentioned this drug yet

brand
Duvyzat
trade names
Duvyzat
generic
givinostat hydrochloride
MOA
Histone deacetylase inhibitor
indication
Polycythemia Vera
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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