GIVINOSTAT HYDROCHLORIDE - Generic Drug Details

What are the generic sources for givinostat hydrochloride and what is the scope of patent protection?

Givinostat hydrochloride is the generic ingredient in one branded drug marketed by Italfarmaco Spa and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Givinostat hydrochloride has ninety-one patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for GIVINOSTAT HYDROCHLORIDE

International Patents:	91
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	17
Patent Applications:	27
DailyMed Link:	GIVINOSTAT HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GIVINOSTAT HYDROCHLORIDE

Constraining patent/regulatory exclusivity:

TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER

Dosage:

SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GIVINOSTAT HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fortrea	PHASE2
Italfarmaco	PHASE2
Fortrea	PHASE3

See all GIVINOSTAT HYDROCHLORIDE clinical trials

Pharmacology for GIVINOSTAT HYDROCHLORIDE

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inhibitors Histone Deacetylase Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for GIVINOSTAT HYDROCHLORIDE

M09AX	Other drugs for disorders of the musculo-skeletal system
M09A	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M09	OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
M	Musculo-skeletal system

US Patents and Regulatory Information for GIVINOSTAT HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes			Y	Y
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes			Y	Y
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes

International Patents for GIVINOSTAT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Argentina	106559
Australia	2016349169
Brazil	112018008870
Brazil	122024001653

Supplementary Protection Certificates for GIVINOSTAT HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3370697	PA2025540	Lithuania		PRODUCT NAME: DUVIZAT (GIVINOSTAT); REGISTRATION NO/DATE: EU/1/25/1930 20250606
3370697	2025C/548	Belgium		PRODUCT NAME: GIVINOSTAT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, INCLUSIEF HYDROCHLORIDEMONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/25/1930 20250606
3370697	CA 2025 00043	Denmark		PRODUCT NAME: GIVINOSTAT I EN HVILKEN SOM HELST FORM BESKYTTET AF BASISPATENTET; REG. NO/DATE: EU/1/25/1930 20250606
3370697	301355	Netherlands		PRODUCT NAME: GIVINOSTAT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING HYDROCHLORIDE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/25/1930 20250606

Market dynamics and financial trajectory for givinostat hydrochloride

Last updated: April 23, 2026

What is givinostat hydrochloride and where is it positioned commercially?

Givinostat hydrochloride (also known as ITF2357, a histone deacetylase [HDAC] inhibitor) is a late-stage oncology drug candidate. The commercial story is shaped by (1) narrow initial indication prospects, (2) complex competitive dynamics in hematologic malignancies and solid tumors, and (3) financing and development timelines typical for pre- or late-commercial-stage oncology assets. Publicly available financial disclosures that tie givinostat specifically to near-term unit sales and revenue do not show a stable, recurring product-commercial base. The trajectory therefore tracks development milestones, partnering/licensing posture, and capital market appetite for late-stage oncology pipelines rather than mature product P&L.

Who controls the commercial path and what does that imply for revenue risk?

Givinostat is developed through an oncology pipeline structure rather than a single, mature operating company product platform. The implication for financial modeling is direct: most “revenue” potential is milestone- and royalty-driven, not unit-driven, unless and until the drug is approved and launched at scale. That shifts the risk profile from commercial execution to binary/regulatory outcomes and payer adoption in the first approved indication.

How do market dynamics shape uptake assumptions?

Market dynamics for givinostat are dominated by three variables:

1. Indication selection and line of therapy

   • Uptake depends on whether givinostat wins positioning as monotherapy or combination partner.
   • In oncology, payer and formulary decisions typically reward demonstrated survival benefit and manageable safety when added to standard-of-care. The HDAC class has a history of variable differentiation across trials, which raises the bar for “practice-changing” efficacy.

2. Competition inside HDAC and broader epigenetic oncology

   • HDAC inhibitors face competition not only from other HDAC agents but also from targeted therapies and immunotherapy regimens that increasingly define first- and second-line standards in multiple tumor types.
   • This compresses the window where a newcomer can expand quickly, pushing value toward specific biomarkers, refractory settings, or combination regimens where standards are weaker.

3. Safety tolerability and combination chemistry

   • HDAC inhibitors can show class-related adverse events. Uptake improves when the tolerability profile supports combination use and when dose intensity does not force early discontinuations.
   • That affects real-world persistence and downstream revenue, particularly if the drug is positioned for chronic or repeated dosing schedules.

What does the financial trajectory likely look like before approval?

For a pre-approval or near-approval asset like givinostat, financial trajectory is expected to follow an oncology-candidate pattern:

• Pre-approval phase: cash burn dominates, financed via equity, grants, and deal structures. Valuation typically moves on trial reads rather than product revenue.
• Late-stage phase: milestone payments and partnering optics matter more than revenue. If a larger pharmaceutical partner steps in (licensing, co-development, or commercialization rights), capital structure can stabilize and reduce dilution pressure.
• Regulatory phase: valuation becomes sensitive to label wording, responder subgroups, and post-approval trial requirements.

Because givinostat has not established a mature product base, the core financial question is not “How fast does uptake occur?” It is “Does the clinical program de-risk enough to enable monetization through licensing, milestones, and eventual sales scaling after launch?”

Where does valuation typically come from for HDAC oncology candidates?

For HDAC oncology assets, investors usually price in:

• probability-weighted approval,
• expected time to approval,
• probability of label expansion,
• and survivability of the differentiation narrative against next-generation standard-of-care.

That is why public market performance often correlates more with protocol updates, endpoints, and regulatory signals than with generic market size metrics. For givinostat, this means the financial trajectory is driven by the ability to convert clinical endpoints into credible payer value and into strong positioning for combination protocols.

What market mechanisms change cash flow once approved?

If givinostat receives approval, cash flow changes through:

1. Launch economics

   • Oncology launches often start with limited prescriber adoption until real-world experience confirms tolerability and efficacy.
   • Early-year growth can be modest if the drug is restricted by line-of-therapy or biomarker criteria.

2. Payer coverage and reimbursement

   • Reimbursement depends on comparable cost-effectiveness versus standard-of-care and the quality of comparative clinical data.
   • A narrower indication drives a steeper ramp profile, while broader labeling supports faster revenue scaling.

3. Combination strategy

   • If givinostat is positioned as a partner drug, revenue can scale with the adoption of the backbone regimen.
   • If it is positioned as monotherapy in refractory disease, revenue depends on the breadth of eligible patient populations and response durability.

How do competitive dynamics affect longer-term revenue sustainability?

Revenue sustainability for an HDAC inhibitor faces two structural constraints:

• Therapeutic substitution risk: newer targeted and immunotherapy combinations can displace HDACs if they provide better incremental benefit.
• Label limitation risk: if trial outcomes support only modest benefit or a narrow subgroup, payer coverage can limit uptake.

As a result, longer-term revenue depends on whether givinostat becomes entrenched in a defensible niche, such as a biomarker-defined population, a specific refractory line, or a combination protocol with durable benefit.

What are the key financial inflection points to track for givinostat?

Even without mature sales data, the financial trajectory is typically shaped by a small number of measurable events:

• Phase-to-phase clinical transitions (endpoint confirmations and protocol amendments)
• Regulatory filings and interactions (acceptance and review milestones)
• Partnering moves (licensing/commercialization agreements, co-development deals)
• Label scope outcomes (indication breadth, biomarker requirements, combination allowances)
• Post-marketing commitments (additional trials that can delay expansions)

Each point can swing valuation quickly because the asset’s cash-generating profile is event-driven.

How does the oncology financing environment affect trajectory?

The pipeline-wide financing environment matters. When capital markets tighten for oncology risk, pre-revenue HDAC programs often face:

• higher dilution risk,
• slower partnering, or
• reduced willingness by large pharma to assume expensive late-stage or commercialization costs.

When capital markets loosen, deals can be structured with stronger upfront payments and clearer risk sharing, which improves near-term runway and reduces balance-sheet stress.

What does “financial trajectory” mean in practical modeling terms?

A practical model for givinostat hydrochloride should treat the drug less like a mature product and more like an option on late-stage outcomes:

• Base case: milestone and royalty potential dominate before launch; sales ramps only if approval lands with label breadth.
• Bull case: broad label and successful combination integration produce faster adoption and higher peak revenue.
• Bear case: narrow label or safety/tolerability constraints limit payer coverage and cap revenue.

In all cases, near-term financial outcomes come from capital structure and deal structures, not from unit economics.

Is there a market-size anchor that can be used for revenue planning?

Oncology revenue planning is anchored by eligible patient populations and line-of-therapy. For givinostat, the anchor is indication-led and line-of-therapy-led rather than class-led. Without a clear, stable approved indication and consistent prescribing footprint, market size inputs remain secondary to label scope and uptake constraints.

Key Takeaways

• Givinostat hydrochloride is a late-stage oncology HDAC inhibitor whose financial trajectory is primarily event-driven rather than sales-driven in the absence of a mature, approved product footprint.
• Market dynamics that govern uptake include indication and line positioning, tolerability for combination use, and competitive substitution by targeted and immunotherapy regimens.
• Valuation and cash-flow expectations typically track probability-weighted clinical and regulatory outcomes, partnering structure, and label scope rather than steady revenue ramp.
• Once approved, revenue sustainability depends on defensible niche adoption, payer coverage, and whether combination protocols support sustained prescribing.

FAQs

1. What primarily drives givinostat hydrochloride value before approval?
Clinical success probabilities, regulatory trajectory, and partnering or licensing terms, which govern milestone and royalty potential.

2. Why does indication breadth matter more than class market size?
In oncology, reimbursement and formulary coverage depend on label scope and line-of-therapy; narrow labeling limits patient access and slows revenue ramp.

3. What market factors can accelerate adoption post-approval?
Demonstrated incremental efficacy, manageable safety in combination regimens, and evidence that the drug fits into real-world treatment pathways.

4. What factors most often cap long-term revenue for HDAC inhibitors?
Therapeutic substitution, narrow label or subgroup restriction, and safety or dose-intensity issues that limit combination uptake.

5. How should financial modeling treat givinostat hydrochloride?
As an event-driven asset where cash-generation pre-launch is milestone and deal-structured, and sales depend on label scope and payer adoption.

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References

[1] US Food and Drug Administration. Drugs@FDA: FDA-Approved Drugs. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency. Human medicines: medicines. EMA. https://www.ema.europa.eu/en/medicines
[3] ClinicalTrials.gov. Givinostat (ITF2357) clinical trials. National Library of Medicine. https://clinicaltrials.gov/