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FDA Orange Book · active-ingredient family

Givinostat hydrochloride

Givinostat hydrochloride: 1 brand, 0 generics; first approved Mar 21, 2024; on patent until Jan 15, 2027.

On patent2 exclusivity periods
Generic status & protection

Protected until Jan 15, 2027 (earliest listed patent expiry).

Earliest patent expiry Jan 15, 2027Latest exclusivity ends Mar 21, 2031
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
5
Next patent expiry
Jan 15, 2027
in 6 mo
Originator applications

Brand (NDA) products

DUVYZATRLDRS
NDA 2178652024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
EQ 8.86MG BASE/MLSUSPENSIONORALRx—
Protection horizon

Patent & exclusivity timeline

20262028203020322034203620382040TodayPatent 7329689 — 2027-01-15Patent 7329689Exclusivity NCE — 2029-03-21Exclusivity NCEExclusivity ODE-473 — 2031-03-21Exclusivity ODE-473Patent 9421184 — 2032-02-03Patent 9421184Patent 9867799 — 2032-02-03Patent 9867799Patent 10688047 — 2036-10-28Patent 10688047Patent 12606519 — 2040-05-03Patent 12606519
Patent expiryExclusivity endToday
Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (2)

  • NCENew chemical entity exclusivity (5 years)

    Mar 21, 2029

    in 2 yr 9 mo

  • ODE-473Orphan-drug exclusivity (7 years)

    Mar 21, 2031

    in 4 yr 9 mo

Orange Book patent file

Listed patents

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
7329689Jan 15, 2027in 6 mo
SubstanceProduct
9421184Feb 03, 2032in 5 yr 8 mo
U-3885
9867799Feb 03, 2032in 5 yr 8 mo
U-3885
10688047Oct 28, 2036in 10 yr 5 mo
ProductU-3885
12606519May 03, 2040in 14 yr
SubstanceProduct
FDA approval span

Approval history

First approval
Mar 21, 2024
2 yr 4 mo ago
Most recent approval
Mar 21, 2024
2 yr 4 mo ago

All 1 application were approved in 2024.

Brand (NDA) 1100%
Generic (ANDA) 00%

Givinostat hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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