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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Givinostat hydrochloride has sixty patent family members in thirty countries.

One supplier is listed for this compound.

Summary for GIVINOSTAT HYDROCHLORIDE

International Patents:	60
US Patents:	4
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
Italfarmaco	PHASE2
Fortrea	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
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
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

International Patents for GIVINOSTAT HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017077436
Croatia	P20210747
Canada	2857082	CHLORURE DE DIETHYL-[6-(4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL)-NAPHTALENE -2-YL-METHYL]AMMONIUM POUR UNE UTILISATION DANS LE TRAITEMENT DE LA DYSTROPHIE MUSCULAIRE (DIETHYL-[6- (4-HYDROXYCARBAMOYL-PHENYL-CARBAMOYLOXY-METHYL)- NAPHTHALEN-2-YL-METHYL]-AMMONIUM CHLORIDE FOR USE IN THE TREATMENT OF MUSCULAR DYSTTROPHY)
Spain	2372280
European Patent Office	3370697
Russian Federation	2721396
New Zealand	741467

Market Dynamics and Financial Trajectory for Givinostat Hydrochloride

Last updated: February 27, 2026

What Is Givinostat Hydrochloride?

Givinostat hydrochloride is an oral histone deacetylase (HDAC) inhibitor originally developed for hematological and solid tumors. It inhibits class I and II HDACs, influencing gene expression and apoptosis. Its primary development focus has been in oncology, particularly for myeloproliferative disorders and rare genetic diseases.

Current Development Status

Development Stage	Status	Initiated By	Key indications under study
Phase 2/3 Trials	Ongoing for various hematological conditions	Vivo Capital; Genenta Science	Polycythemia vera; myelofibrosis; rare pediatric diseases
Preclinical/Indications	Investigated for neurodegenerative diseases, fibrosis	Multiple academic collaborations	Multiple sclerosis; systemic sclerosis

Note: Givinostat is not yet approved for commercial distribution in the US or Europe. Its clinical trial results are critical for future market expansion.

Market Size and Forecast

Hematological Malignancies

• The global HDAC inhibitor market was valued at approx. $530 million in 2022, expected to reach $1.2 billion by 2030, with a CAGR of 10%[1].
• Givinostat’s potential share hinges on success in myeloproliferative neoplasms (MPNs). The polycythemia vera (PV) segment alone was valued at $250 million in 2022, with a projected CAGR of 6%[2].

Rare Diseases and Orphan Drug Market

• Givinostat’s orphan drug designation for certain pediatric genetic disorders can mean extended exclusivity and premium pricing.
• The global orphan drug market was valued at $175 billion in 2022, with a CAGR of around 12%[3].

Competitive Landscape

Major competitors	Market Focus	Approved Indications	Notable pipeline drugs
Vorinostat (Zolinza)	Oncology, cutaneous T-cell lymphoma	T-cell lymphoma	Panobinostat (FDA-approved for multiple myeloma)
Belinostat (Beleodaq)	Hematologic malignancies	Peripheral T-cell lymphoma	No FDA-approved products in the pipeline
Panobinostat (Farydak)	Multiple myeloma	Multiple myeloma	Approved by FDA 2015

Regulatory and Market Entry Barriers

• Clinical Trial Risks: Givinostat’s efficacy and safety profile in late-stage trials remain unproven.
• Pricing and Reimbursement: High development costs and uncertain reimbursement pathways in different markets.
• Competitive Pressure: Established HDAC inhibitors with approved indications limit market share growth potential.

Financial Trajectory and Investment Outlook

Key Factors	Details
R&D Expenditure	Estimated $50–80 million for ongoing trials (per company data)
Funding Sources	Venture capital; governmental grants; partnerships
Potential Market Entry Revenue	Forecasted to reach $500 million in active sales if approved by 2030, based on comparable drugs’ uptake within niche indications
Licensing and Partnerships	Partnering with Big Pharma for late-stage development and commercialization

Revenue Projections (Scenario-Based)

Scenario	Year 2025	Year 2030	Market Share	Revenue Estimate (USD)
Optimistic	50 million	400 million	10% in relevant indications	$400 million - $500 million
Pessimistic	10 million	50 million	2% in relevant indications	<$100 million

Note: Realization depends on trial outcomes, regulatory approvals, and market acceptance.

Risks and Opportunities

Risks

• Clinical Failure: Negative trial readouts could delay or prevent market entry.
• Market Penetration: Established competitors may relegate Givinostat to a niche position.
• Regulatory Delays: Approvals in key markets could be delayed due to data deficiencies or safety concerns.

Opportunities

• Rare Disease Focus: Orphan designation affords exclusivity, higher pricing power.
• Combination Therapies: Potential to combine with existing treatments to enhance efficacy.
• Emerging Indications: Expansion into neurodegenerative and fibrotic diseases.

Key Takeaways

• Givinostat hydrochloride is in late-stage clinical trials for specific hematological and rare diseases, with no current approvals.
• The global HDAC inhibitor market is expanding, driven by oncology and rare disease segments.
• Its market potential depends heavily on successful trial outcomes, regulatory approval, and ability to differentiate from existing treatments.
• Financial trajectories suggest low eight-figure revenues initially, scaling over time with approval and market penetration.
• Competitive landscape favors established drugs, yet orphan designations provide a strategic advantage.

FAQs

Q1: What is the primary therapeutic use of Givinostat hydrochloride?
A1:** It targets hematological malignancies and rare genetic disorders through HDAC inhibition.

Q2: What markets could Givinostat access upon approval?
A2:** Hematology, rare childhood diseases, neurodegenerative and fibrotic conditions.

Q3: When could Givinostat generate significant revenue?
A3:** If approved within the next 3–5 years and successfully commercialized, revenues could reach hundreds of millions annually by 2030.

Q4: Who are the main competitors?
A4:** Vorinostat, belinostat, and panobinostat are leading approved HDAC inhibitors.

Q5: What are the main development risks?
A5:** Clinical trial failures, regulatory delays, and market competition.

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References

[1] MarketsandMarkets. (2022). Histone Deacetylase (HDAC) Inhibitors Market.
[2] Grand View Research. (2023). Hematology Drugs Market Size, Trends & Forecast.
[3] EvaluatePharma. (2023). Global Orphan Drug Market Data.