DUVYZAT Drug Patent Profile

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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 five patents protecting this drug.

The generic ingredient in DUVYZAT is givinostat hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. 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

US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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.

Pharmacology for DUVYZAT

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

US Patents and Regulatory Information for DUVYZAT

DUVYZAT is protected by five 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	9,421,184
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	12,606,519		Y	Y
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	9,867,799
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes	10,688,047		Y
Italfarmaco Spa	DUVYZAT	givinostat hydrochloride	SUSPENSION;ORAL	217865-001	Mar 21, 2024		RX	Yes	Yes

International Patents for DUVYZAT

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

Country	Patent Number	Title	Estimated Expiration
Argentina	106559
Australia	2016349169
Brazil	112018008870
Brazil	122024001653
Canada	3002755
Chile	2018001151

Supplementary Protection Certificates for DUVYZAT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3370697	C20250035	Finland
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
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	LUC50029	Luxembourg		PRODUCT NAME: GIVINOSTAT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE CHLORHYDRATE MONOHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/25/1930 20250606

DUVYZAT (givinostat) market dynamics and financial trajectory: sales, payer adoption, pricing, and exclusivity-driven risk

Last updated: July 28, 2026

Executive summary: DUVYZAT (givinostat) is a niche, hospital-and-specialty-administered oral drug with revenue tightly linked to (1) pediatric-inclusion dynamics for Duchenne muscular dystrophy (DMD), (2) payer prior authorization friction, and (3) durability of regulatory and patent exclusivity headwinds. Financial trajectory hinges on whether prescriptions scale beyond initial specialty centers and whether payer coverage holds as competitors and future DMD entrants widen formularies. The first major swing factor is cohort expansion and conversion from off-label pathways, driven by evidence generation and payer comfort with the benefit-risk profile.

What is DUVYZAT (givinostat) used for and where does it sit in DMD treatment?

Featured snippet answer: DUVYZAT (givinostat) is an oral therapy for Duchenne muscular dystrophy that targets a defined patient population with disease activity where treatment adds to background standard care.

Indication, population, and line of therapy

• DUVYZAT is positioned within the DMD treatment landscape as an adjunct option, not a replacement for corticosteroids or exon-skipping therapies where applicable.
• Real-world adoption depends on:
  • confirmation of eligibility criteria in prescribing workflows,
  • neurologist/muscular dystrophy specialist density,
  • and access to genetic confirmation and disease monitoring infrastructure.

Administration model that shapes market adoption

• Oral dosing reduces infusion-center dependence but shifts adoption to specialty pharmacy coordination, caregiver adherence support, and frequent lab monitoring.
• Market penetration is therefore constrained by specialty pharmacy reach and payer automation of authorization.

How fast can DUVYZAT expand commercially in Duchenne muscular dystrophy?

Featured snippet answer: Uptake is capped at first by patient identification and payer authorization speed, then accelerates if specialists converge on givinostat as a standard adjunct for eligible DMD patients.

Key demand drivers

• Eligibility clarity and coding: DMD is heterogeneous; adoption depends on unambiguous eligibility coding used in prior authorization systems.
• Specialty center conversion: DMD care is concentrated in regional centers. A patient funnel exists only where neuromuscular teams actively prescribe.
• Real-world evidence uptake: Payers tolerate limited initial evidence if clinical endpoints align with their evidence standards and if access outcomes are stable.

Friction points that typically slow initial sales

• Prior authorization requirements tied to disease stage and baseline functional measures.
• High administrative load for pediatric beneficiaries.
• Reliance on specialty pharmacy for start-up, education, and refill adherence.

DUVYZAT pricing and reimbursement: how do payers decide coverage in specialty rare pediatrics?

Featured snippet answer: Payer adoption is dominated by prior authorization governance, evidence thresholds, and net price structure (rebates and patient assistance), not by list price alone.

Coverage pathway effects

• Large commercial plans often require:
  • documentation of diagnosis via genetic confirmation,
  • treatment history alignment (background standard care),
  • and a structured monitoring plan.
• Medicaid coverage is frequently less flexible but can be more predictable once criteria are published.

Net pricing and access mechanics

• Net revenue is shaped by:
  • specialty pharmacy distribution contracts,
  • rebate participation,
  • and patient assistance utilization for cash-pay gaps.
• In rare disease pediatrics, payer negotiations often target population restriction rather than headline discount rates.

When does DUVYZAT face exclusivity and patent expiration pressure?

Featured snippet answer: The commercial durability for DUVYZAT depends on the remaining patent and regulatory exclusivity wall for its active ingredient and its protected uses and formulations; once those erode, generic or biosimilar-like entry dynamics for small molecules can compress net pricing.

Exclusivity-driven risk model

For small-molecule DMD assets like givinostat, the relevant timing risks are:

• patent term end for composition-of-matter,
• additional patent layers for methods-of-use, dosing regimens, and formulation,
• and regulatory exclusivity, if applicable under the drug’s approval pathway.

Generic entry scenario logic

• If the earliest expiry approaches, investors and commercial teams model:
  • formulary tier displacement,
  • rebate pressure,
  • and a decline in authorized prescriptions as payers prefer lower-cost alternatives.

What patents protect DUVYZAT, and how strong is the patent estate for market exclusivity?

Featured snippet answer: DUVYZAT’s patent estate is evaluated across composition-of-matter, method-of-use, and product-specific claims; the estate’s strength determines whether market exclusivity is durable through generic challenge cycles.

Patent estate components that matter for challengers

• Composition-of-matter claims covering givinostat and key chemical variants.
• Method-of-use claims aligned to DMD patient subsets and endpoints.
• Formulation and dosing claims that constrain “design-around” strategies.

How patent strength translates to sales outcomes

• Strong estates tend to:
  • deter Paragraph IV filings,
  • preserve higher net prices,
  • and extend payer confidence in continuity of supply.
• Narrow estates often invite early entry pressure, pushing payers toward restricted access or benefit carve-outs.

How many Paragraph IV generic challenges are likely to affect DUVYZAT, and when?

Featured snippet answer: The probability of Paragraph IV filings is tied to how late-stage the patent “burden” is and how easy it is to craft non-infringing dosing and method-of-use positions.

Paragraph IV timing dynamics

• If the patent “last to expire” is far out, filings cluster near that date.
• If there is a single dominant barrier patent, challengers often test it early with the highest litigation leverage.

Settlement and “at-risk” entry implications

• Generic settlements typically include:
  • entry date triggers,
  • shared exclusivity terms (where applicable),
  • and market allocation conditions in some agreements.
• At-risk launch threatens DUVYZAT’s realized price even without final judgment if payers move first.

What is the Orange Book status of DUVYZAT, and what listings create the biggest entry barriers?

Featured snippet answer: Orange Book listings determine how challengers frame infringement and how payers plan formularies for future switches.

What to track in Orange Book entries

• Active ingredient and dosage form coverage.
• Patent expiry dates.
• Listing type: composition, method-of-use, or formulation.
• Exclusivity codes (if listed).

Payer relevance

• Coverage decisions often track expiry calendars and litigation posture.
• Payers prefer certainty, so Orange Book clarity changes formulary planning timelines.

What DUVYZAT litigation affects competitive entry and commercial stability?

Featured snippet answer: Litigation affects DUVYZAT mainly through whether courts slow generic entry and through settlement terms that set entry timelines.

Key litigation outcomes that move the revenue curve

• Preliminary injunctions that block launch.
• Final judgments that uphold core patents.
• Settlement agreements that define hard entry dates.

Portfolio and center-of-gravity effects

• If litigation narrows patent scope, generic companies may pursue fewer but more targeted filings.
• Strong litigation outcomes tend to reduce “churn” in payer authorization rules.

How does DUVYZAT compare with other DMD drugs on adoption barriers and payer fit?

Featured snippet answer: DUVYZAT’s adoption depends on how its access model competes with steroid backbone and exon-skipping or other adjunct therapies, and whether payer criteria match DMD clinic workflows.

Comparison dimensions that drive market share

• Eligibility complexity versus comparator simplicity.
• Monitoring burden relative to competitors.
• Evidence strength and endpoint alignment.
• Specialty pharmacy and distribution footprint.

Where DUVYZAT can win

• When it fits a defined subset of DMD patients that is stable year-over-year.
• When payer rules can be automated in authorization.

Where DUVYZAT can lose

• When it becomes a “later line” option with restricted payer coverage.
• When competitors offer easier reimbursement pathways or better alignment with payer medical policy.

What competitive landscape dynamics matter for DUVYZAT revenue?

Featured snippet answer: The competitive set for DUVYZAT is driven by (1) DMD pipeline and label expansions, (2) formulary inclusion mechanics, and (3) net-price pressure from upcoming alternatives.

Commercial forces

• Formulary tightening: Payers reduce tiering flexibility for new entrants.
• Net price compression: Even without direct substitution, rebates intensify.
• Therapy line competition: Adjunct positioning means uptake depends on whether physicians choose it early or only after other options.

Geographic dynamics

• Specialty rare disease sales skew toward:
  • markets with dense neuromuscular specialist networks,
  • payer systems with faster authorization cycles,
  • and strong specialty pharmacy distribution.

DUVYZAT sales trajectory: what patterns typically show up in niche DMD launches?

Featured snippet answer: Niche DMD assets usually show a three-phase revenue curve: initial center-driven adoption, scaling contingent on payer processes, and later volatility tied to formulary changes and exclusivity expectations.

Phase 1: launch and center adoption

• Prescription activity concentrated among early adopters.
• Marketing spend influences physician awareness and prior authorization comfort.

Phase 2: payer scaling

• Net price outcomes and authorization simplification determine whether prescriptions grow beyond early specialty centers.
• Patient persistence matters: missed refills or adherence gaps can reduce realized revenue.

Phase 3: exclusivity and competitive pressure

• As competitors expand indications or pricing pressure rises, DUVYZAT experiences net revenue compression even if patient numbers remain steady.

How to read the financial trajectory

• Revenue is most sensitive to:
  • new patient starts,
  • persistence (refill rates and adherence),
  • and realized price after rebates.

What business risks could derail DUVYZAT market growth?

Featured snippet answer: The highest commercial risks are payer restriction, slower-than-expected patient identification, and patent or litigation outcomes that accelerate generic entry.

Top risk categories

• Access risk: prior authorization tightening, benefit carve-outs, or limited criteria.
• Evidence-driven risk: clinical outcomes that fail to expand payer willingness to cover broader subgroups.
• Exclusivity risk: earlier-than-modeled expiry or successful challenger strategies.
• Supply and adherence risk: pediatric adherence failures can reduce persistence and net revenue.

What financial upside levers can extend DUVYZAT revenue?

Featured snippet answer: Upside comes from expanding eligible patient subsets, improving payer coverage speed, and sustaining high persistence through adherence support and monitoring programs.

Upside levers

• Label expansion into broader DMD subsets where it adds measurable value.
• Evidence strengthening that supports inclusion in medical policy.
• Payer-facing program design that reduces authorization friction.
• Specialist education that improves coding and eligibility documentation.

Key Takeaways

• DUVYZAT’s revenue trajectory is driven by DMD patient identification, specialty center prescribing, payer authorization speed, and persistence in a pediatric population.
• Net revenue depends more on rebate and prior authorization outcomes than on list pricing.
• Exclusivity and patent estate durability determine whether payers maintain coverage confidence or begin preemptive formulary restriction.
• Litigation posture and settlement terms are the principal near-term levers that can prevent early generic price pressure.

FAQs

1. How do prior authorization criteria for DUVYZAT affect time-to-therapy start and realized revenue?
2. What Orange Book patent listings for DUVYZAT are most likely to be targeted in future generic Paragraph IV challenges?
3. How does DUVYZAT persistence (refill adherence) typically influence quarterly sales in pediatric rare disease?
4. What settlement structures in DMD small-molecule patent cases most impact branded net price after generic launch?
5. Which DMD subgroups are most likely to drive incremental prescriptions for DUVYZAT under payer policy frameworks?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. U.S. Food and Drug Administration. Drug Approval and Safety Communications. https://www.fda.gov/drugs/drug-safety-and-availability
3. U.S. Food and Drug Administration. Drug Trials Snapshots. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots