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DUVYZAT

NDA

GIVINOSTAT HYDROCHLORIDE | N217865 | ITALFARMACO SPA

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (4)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

Jan. 15, 2027

Feb. 3, 2032

Feb. 3, 2032

Oct. 28, 2036

May. 3, 2040

NCE

Mar. 21, 2029

ODE-473

Mar. 21, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

13 trials from ClinicalTrials.gov, 1 active, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Long-term Study Evaluating the Effect of Givinostat in Patients With Chronic Myeloproliferative Neoplasms NCT01761968	Phase 2	Active	Italfarmaco	90	2013-03 → 2026-12
Phase II Study of GIVINOSTAT (ITF2357) in Combination With Hydroxyurea in Polycythemia Vera NCT00928707	Phase 2	Completed	Italfarmaco	45	2009-06 → 2011-10
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Duchenne Muscular Dystrophy NCT02851797	Phase 3	Completed	Italfarmaco	179	2017-06-06 → 2022-02-22
A Two-part Study to Assess the Safety and Preliminary Efficacy of Givinostat in Patients With Polycythemia Vera NCT01901432	Phase 1/2	Completed	Italfarmaco	48	2013-10 → 2017-09-25
Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy NCT03238235	Phase 2	Completed	Italfarmaco	51	2018-01-09 → 2021-03-19
Open Label, Multicentre Trial to Assess Safety and Efficacy of ITF2357 in Active Systemic Juvenile Idiopathic Arthritis NCT00570661	Phase 2	Completed	Italfarmaco	17	2006-09-12 → 2013-06-10
A Study to Assess Safety/Tolerability, pk, Effects on Histology, Clinical Parameters of Givinostat in Children With DMD NCT01761292	Phase 1/2	Completed	Italfarmaco	20	2013-04 → 2017-11
Trial of the Histone-Deacetylase Inhibitor ITF2357 Followed by Mechlorethamine in Relapsed/Refractory Hodgkin's Lymphoma NCT00792467	Phase 1/2	Completed	Italfarmaco	24	2008-02 → 2010-09
Phase IIA Study of the HDAC Inhibitor ITF2357 in Patients With JAK-2 V617F Positive Chronic Myeloproliferative Diseases NCT00606307	Phase 2	Completed	Italfarmaco	29	2007-12 → 2008-12
Phase II Study of Histone-deacetylase Inhibitor ITF2357 in Refractory/Relapsed Lymphocytic Leukemia NCT00792831	Phase 2	Terminated	Italfarmaco	3	2008-02 → 2009-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$27996.24

Highest Price

$37922.17

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
11797-0110-02GIVINOSTAT 8.86MG/ML SUSP,ORAL	$37922.17	FSS	ITF Therapeutics LLC	05/14/2030
11797-0110-02GIVINOSTAT 8.86MG/ML SUSP,ORAL	$27996.24	Big4	ITF Therapeutics LLC	05/14/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Duvyzat (2024)

Total Spending

$2.0M

Total Claims

Beneficiaries

—

Avg Cost/Unit

$268.72

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHEMI SPAGIVINOSTAT HYDROCHLORIDE MONOHYDRATE

DMF 373442023

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 22, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 8.86MG BASE/ML

RLD

5 patents2 exclusivities▴

SUSPENSION;ORAL | Approved: Mar 21, 2024

Patents (5) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7329689	Jan 15, 2027	—	Yes	Yes	—	—
9421184	Feb 3, 2032	—	—	—		—
9867799	Feb 3, 2032	—	—	—		—
10688047	Oct 28, 2036	—	—	Yes		—
12606519	May 3, 2040	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	Mar 21, 2029	Active
ODE-473	Mar 21, 2031	Active