DUVYZAT

GrowthSM

givinostat

Italfarmaco Research

NDAORALSUSPENSIONPriority Review

Approved

Mar 2024

Lifecycle

Growth

Competitive Pressure

0/100

Mechanism of Action

Histone Deacetylase Inhibitors

Pharmacologic Class:

Histone Deacetylase Inhibitor

Indications (2)

Duchenne muscular dystrophy (DMD) in patients 6 years of age older

Loss of Exclusivity

LOE Date

Oct 28, 2036

129 months away

Patent Expiry

Oct 28, 2036

Exclusivity Expiry

Mar 21, 2031

Patent Records (4)

Patent #	Expiry	Type	Use Code
7329689	Jan 15, 2027	SubstanceProduct	—
9421184	Feb 3, 2032		U-3885
9867799	Feb 3, 2032		U-3885
10688047	Oct 28, 2036	Product	U-3885

Company

Italfarmaco Research

Italy - Cinisello Balsam

External Resources

Full prescribing information

FDA approval history

Drug nomenclature & identifiers