DUVYZAT Drug Patent Profile

Which patents cover Duvyzat, and when can generic versions of Duvyzat launch?

Duvyzat is a drug marketed by Italfarmaco Spa and is included in one NDA. There are four patents protecting this drug.

This drug has sixty patent family members in thirty countries.

The generic ingredient in DUVYZAT is givinostat hydrochloride. Additional details are available on the givinostat hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Duvyzat

Duvyzat will be eligible for patent challenges on March 21, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 21, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DUVYZAT

International Patents:	60
US Patents:	4
Applicants:	1
NDAs:	1
Patent Applications:	1,533
What excipients (inactive ingredients) are in DUVYZAT?	DUVYZAT excipients list
DailyMed Link:	DUVYZAT at DailyMed

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

Constraining patent/regulatory exclusivity:

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

NDA:

217865

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.

US Patents and Regulatory Information for DUVYZAT

DUVYZAT is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y

International Patents for DUVYZAT

See the table below for patents covering DUVYZAT around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013114413
Slovenia	3370697
Mexico	380361
Italy	MI20030063	CLORIDRATO MONOIDRATO DELL'ESTERE (6-DIETILAMMINOMETIL-NAFTALEN-2-IL)METILICO DELL'ACIDO (4-IDROSSICARBAMMOIL-FENIL)CARBAMMICO.

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DUVYZAT

Last updated: July 27, 2025

---

Introduction

The pharmaceutical landscape is characterized by rapid innovation, shifting regulatory frameworks, and evolving market demands. DUVYZAT, a novel pharmaceutical agent, is poised to secure a significant foothold within its targeted therapeutic segment. This report comprehensively analyzes the market dynamics impacting DUVYZAT's commercialization and project its potential financial trajectory, offering strategic insights for stakeholders.

---

Overview of DUVYZAT

DUVYZAT is a recently approved medication designed to treat [specific condition], with its efficacy demonstrated through pivotal clinical trials. Its unique mechanism of action targets [specific pathways], positioning it as a potentially superior alternative within existing standards of care. The drug received regulatory approval from [regulatory agency] in [year], following robust safety and efficacy assessments.

---

Market Landscape and Demand Drivers

1. Therapeutic Area Growth

The targeted therapeutic area for DUVYZAT shows robust growth projections. According to [source], the global market for [condition]-related drugs is expected to reach USD [value] billion by [year], registering a CAGR of [percentage]% from [year] to [year]. Factors fueling this expansion include increased disease prevalence, enhanced diagnostic capabilities, and the advent of personalized medicine.

2. Unmet Medical Needs

Despite existing treatments, significant unmet needs remain. Current therapies often suffer from limitations such as suboptimal efficacy, adverse effects, and patient compliance issues. DUVYZAT addresses these gaps with its improved safety profile and convenient administration, reinforcing its potential market demand.

3. Regulatory and Reimbursement Environment

Regulatory bodies, including the FDA and EMA, have displayed a propensity for expedited pathways for drugs targeting unmet needs. DUVYZAT's fast-track designation (if applicable) and favorable reimbursement policies could accelerate its market access and adoption rates.

4. Competitive Landscape

The market features established agents like [competitor drugs], with combined global sales exceeding USD [value] billion. DUVYZAT aims to differentiate through superior efficacy and tolerability, but penetrating this competitive space demands strategic market positioning and pricing strategies.

---

Market Challenges and Risks

1. Patent Landscape and Generic Competition

Patent exclusivity will be critical; expiry timelines influence forecasting accuracy. The potential entry of generic competitors post-patent expiry could dramatically erode market share and revenues.

2. Pricing and Reimbursement

Pricing strategies must balance profitability with payer acceptance. Resistance from payers to high-cost therapies could constrain DUVYZAT's market penetration, especially in price-sensitive markets.

3. Clinical Adoption and Physician Acceptance

Physician prescribing habits strongly influence commercial success. Education campaigns and evidence generation are necessary to foster confidence among clinicians, especially in cases where existing treatment paradigms are well-established.

---

Financial Trajectory and Revenue Projections

1. Forecasting Methodology

Revenue projections rely on assumptions including the target patient population, market penetration rate, pricing, and competitive dynamics. Adoption curves are modeled using standard diffusion techniques adjusted for disease prevalence and payer landscapes.

2. Revenue Projections (Next 5 Years)

Based on current market conditions, forecasts suggest:

• Year 1: USD [value] million, primarily from early adopters, limited by initial market access challenges.
• Year 2: USD [value] million, with expanded prescribing as awareness campaigns gain traction.
• Year 3: USD [value] billion, capturing [percentage]% of the addressable market, driven by increased physician acceptance and reimbursement coverage.
• Year 4–5: Revenue growth stabilizes at USD [value] billion, with market saturation and possible entry of biosimilars or generics considered.

Note: These figures account for patent exclusivity periods, regulatory milestones, and competitive responses.

3. Cost Considerations

Development, manufacturing, and commercialization costs are projected following industry standards, with initial high promotional expenses declining over time as market confidence solidifies.

---

Strategic Opportunities for Amplified Financial Impact

• Market Expansion: Leveraging emerging markets with favorable regulatory frameworks and lower pricing thresholds.
• Partnerships: Collaborations with local distributors or co-promoters to enhance reach.
• Line Extensions: Developing dosage variants or combination therapies to expand indications.
• Patient Support Programs: Enhancing adherence and satisfaction, thereby boosting market share.

---

Regulatory and Patent Outlook

Protection of intellectual property remains vital. Securing patent rights over formulation, delivery mechanisms, and biomarkers enhances market exclusivity. Ongoing patent litigations or generic challenges should be monitored diligently to safeguard revenue streams.

---

Conclusion

DUVYZAT stands at a strategic intersection of innovation and market opportunity. Its success hinges on effective navigation of competitive pressures, regulatory pathways, and reimbursement landscapes. While substantial revenue prospects are evident, prudent risk management and proactive stakeholder engagement are essential for optimizing its financial trajectory.

---

Key Takeaways

• Market Demand: DUVYZAT’s targeted niche exhibits significant growth potential driven by unmet medical needs.
• Competitive Advantage: Its novel mechanism and safety profile position it favorably against existing therapies.
• Revenue Potential: Projected to reach USD [value] billion within five years, contingent on market access and adoption rates.
• Risks and Challenges: Patent expiry, payer resistance, and competition necessitate strategic planning.
• Strategic Imperatives: Focus on expanding indications, securing patent protections, and fostering physician education.

---

FAQs

1. What factors primarily influence DUVYZAT’s market success?
Market success depends on regulatory approval timelines, pricing strategies, physician adoption, payer acceptance, and patent protection duration.

2. How does patent exclusivity impact DUVYZAT’s revenue projections?
Patent exclusivity dictates the period during which DUVYZAT can operate without generic competition, directly affecting long-term revenue potential.

3. What competitive threats could diminish DUVYZAT’s market share?
Introduction of generic versions post-patent expiry, competing drugs with similar efficacy, or innovations offering superior benefits.

4. Which markets present the highest growth opportunities for DUVYZAT?
Emerging markets with expanding healthcare infrastructure and favorable regulatory environments offer substantial growth prospects.

5. How can DUVYZAT’s manufacturer mitigate reimbursement challenges?
By demonstrating cost-effectiveness through clinical data, engaging with payers early, and developing patient assistance programs to improve affordability.

---

References

[1] Market research data from [industry reports].
[2] Regulatory agency publications and approval documents.
[3] Clinical trial results and efficacy data.
[4] Industry analyses on competitive landscapes.
[5] Patent filings and intellectual property reports.

---