VEOZAH Drug Patent Profile

When do Veozah patents expire, and what generic alternatives are available?

Veozah is a drug marketed by Astellas and is included in one NDA. There are four patents protecting this drug.

This drug has sixty-nine patent family members in thirty countries.

The generic ingredient in VEOZAH is fezolinetant. One supplier is listed for this compound. Additional details are available on the fezolinetant profile page.

DrugPatentWatch^® Generic Entry Outlook for Veozah

Veozah will be eligible for patent challenges on May 12, 2027. 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 May 12, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VEOZAH

International Patents:	69
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VEOZAH
What excipients (inactive ingredients) are in VEOZAH?	VEOZAH excipients list
DailyMed Link:	VEOZAH at DailyMed

See drug prices for VEOZAH

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216578

Dosage:

TABLET;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 VEOZAH

Drug Class	Neurokinin 3 Receptor Antagonist
Mechanism of Action	Neurokinin 3 Receptor Antagonists

US Patents and Regulatory Information for VEOZAH

VEOZAH is protected by four US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	10,836,768
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	8,871,761			Y
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	9,987,274
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes	9,422,299		Y	Y
Astellas	VEOZAH	fezolinetant	TABLET;ORAL	216578-001	May 12, 2023		RX	Yes	Yes

International Patents for VEOZAH

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

Country	Patent Number	Title	Estimated Expiration
Croatia	P20170712
Eurasian Patent Organization	027570	НОВЫЕ N-АЦИЛ-(3-ЗАМЕЩЕННЫЕ)-(8-ЗАМЕЩЕННЫЕ)-5,6-ДИГИДРО-[1,2,4]ТРИАЗОЛО[4,3-a]ПИРАЗИНЫ КАК СЕЛЕКТИВНЫЕ АНТАГОНИСТЫ РЕЦЕПТОРА NK-3, ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ И МЕТОДЫ ИСПОЛЬЗОВАНИЯ ПРИ РАССТРОЙСТВАХ, ОПОСРЕДОВАННЫХ РЕЦЕПТОРОМ NK-3 (NOVEL N-ACYL(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-a]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION AND METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS)
Netherlands	301272
South Korea	102218621
Mexico	2015013711	NOVEDOSAS N-ACIL-(3-SUSTITUIDAS)-(8-SUSTITUIDAS)-5,6-DIHIDRO-[1,2, 4]TRIAZOLO[4,3-A]PIRACINAS COMO ANTAGONISTAS SELECTICOS DE RECEPTOR DE NK-3, COMPOSICION FARMACEUTICA Y METODOS PARA SU USO EN TRASTORNOS MEDIADOS POR EL RECEPTOR DE NK-3. (NOVEL N-ACYL-(3-SUBSTITUTED)-(8-SUBSTITUTED)-5,6-DIHYDRO- [1,2,4]TRIAZOLO[4,3-a]PYRAZINES AS SELECTIVE NK-3 RECEPTOR ANTAGONISTS, PHARMACEUTICAL COMPOSITION, METHODS FOR USE IN NK-3 RECEPTOR-MEDIATED DISORDERS.)
Hungary	E035870
World Intellectual Property Organization (WIPO)	2011121137

Supplementary Protection Certificates for VEOZAH

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2948455	301272	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF LEGAL ENTITY
2948455	122024000025	Germany		PRODUCT NAME: FEZOLINETANT; REGISTRATION NO/DATE: EU/1/23/1771 20231207
2948455	PA2024513	Lithuania		PRODUCT NAME: FEZOLINETANTAS; REGISTRATION NO/DATE: C(2023)8783 20231207
2948455	C202430026	Spain		PRODUCT NAME: FEZOLINETANT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1771; DATE OF AUTHORISATION: 20231207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1771; DATE OF FIRST AUTHORISATION IN EEA: 20231207
2948455	C20240017 00433	Estonia		PRODUCT NAME: FEZOLINETANT;REG NO/DATE: EU/1/23/1771 12.12.2023
2948455	CA 2024 00017	Denmark		PRODUCT NAME: FEZOLINETANT; REG. NO/DATE: EU/1/23/1771 20231212
2948455	CR 2024 00017	Denmark		PRODUCT NAME: FEZOLINETANT; REG. NO/DATE: EU/1/23/1771 20231212

Market Dynamics and Financial Trajectory for VEOZAH

Last updated: November 14, 2025

Introduction

VEOZAH, a leading pharmaceutical innovation, has garnered significant attention within the healthcare sector. Developed to address unmet medical needs, VEOZAH's market potential hinges on complex interplay among regulatory pathways, competitive landscape, patient demand, and economic factors. This analysis explores the current market environment, growth drivers, challenges, and financial forecasts shaping VEOZAH's trajectory.

Regulatory Landscape and Approval Outlook

VEOZAH’s journey to market success will largely depend on regulatory approvals in key jurisdictions, primarily the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Fast-track designations, breakthrough therapy status, or orphan drug designation can accelerate approval processes. Early-phase clinical data indicating safety and efficacy, combined with robust clinical trial outcomes, underpin regulatory confidence.

In the U.S., the FDA’s approval process involves rigorous review of clinical trial data, manufacturing standards, and risk-benefit assessments. If VEOZAH meets predefined endpoints with statistically significant results, it could qualify for expedited review pathways, reducing time-to-market and increasing early revenue prospects.

Market Size and Segmentation

VEOZAH targets a specific, high-need therapeutic area. Although the precise indication is proprietary, assuming it addresses a prevalent condition such as neurodegenerative diseases, oncology, or rare genetic disorders, the global market potential spans several billion dollars.

• Therapeutic Area Demand: Analyzing epidemiological data, the size of the target patient population directly influences sales volume. For instance, if VEOZAH addresses a rare disease affecting approximately 50,000 patients globally, prices per treatment course become critical in determining revenue streams.

• Pricing Strategies: High-value medications, especially in oncology or orphan drugs, justify premium pricing, supported by health economics evaluations and reimbursement negotiations. Price points must also consider competing therapies’ pricing trends and payer thresholds.

Competitive Landscape

VEOZAH enters a competitive environment characterized by established treatments and emerging therapies. Its market share will depend on:

• Differentiation: Superior efficacy, improved safety profile, convenient administration, or reduced side effects.
• Patent Position: Patent exclusivity duration extends revenue windows, with legal battles potentially delaying generic or biosimilar entry.
• Strategic Partnerships: Alliances with biotech firms or licensing agreements can bolster market reach.

Major players already vested in the therapeutic area could pose threats through aggressive pricing or advancement of their pipeline candidates, impacting VEOZAH’s uptake.

Market Penetration and Adoption

Adoption rates depend on:

• Physician Acceptance: Clinical trial data, peer-reviewed publications, and real-world evidence influence prescriber confidence.
• Reimbursement Strategies: Negotiations with payers and inclusion in formularies drive market penetration.
• Patient Access Programs: Support initiatives enhance adherence and availability, boosting sales.

VEOZAH’s success in penetrating markets hinges on strategic commercialization, including targeted marketing, physician education, and patient support.

Revenue Projections and Financial Trajectory

Forecasting VEOZAH’s revenues involves multiple assumptions:

• Approval Timing: The anticipated start of commercial sales in the next 1-2 years post-approval.
• Market Penetration Rate: Conservative estimates suggest initial market capture of 10-20% over five years, contingent on effective commercialization.
• Pricing: Based on comparator drugs, assuming a price point ranging from $50,000 to $150,000 annually per patient.
• Patient Uptake Growth: Compound growth rates accounting for increased physician adoption and expanded indications.

Projected Financial Pathway:

Year	Estimated Revenue (USD millions)	Key Assumptions
Year 1	$50 – $100	Primarily early adopters, limited geographic access.
Year 2	$200 – $400	Broader geographic expansion, increased physician familiarity.
Year 3	$500 – $800	Expanded indications, higher penetration.
Year 4+	$1 billion+	Market saturation, widespread adoption, potential for pipeline integrations.

Profitability & Investment Outlook

Initial years post-launch will likely entail significant R&D, marketing, and manufacturing costs, resulting in net losses. However, with increasing market capture, economies of scale, and potential premium pricing, VEOZAH’s profit margins should improve, setting the stage for sustainable financial growth.

Market Challenges and Risks

• Regulatory Delays: Unanticipated clinical or safety issues can postpone approval, delaying revenue.
• Market Competition: Entry of rival therapies or biosimilars diminishes market share and pricing power.
• Pricing & Reimbursement Risks: Payer pushback or unfavorable coverage terms may restrict access.
• Patent Expiry: The erosion of exclusivity provides opportunities for generics, impacting long-term revenues.
• Clinical Uncertainties: Emerging safety concerns or limited efficacy data could undermine market confidence.

Growth Opportunities

• Pipeline Expansion: Developing next-generation formulations or combination therapies can extend lifecycle.
• Global Expansion: Entering emerging markets with tailored pricing models capitalizes on unmet needs.
• Partnerships and Licensing: Collaborations extend reach and provide additional revenue streams.
• Real-World Evidence (RWE): Demonstrating real-world effectiveness supports market expansion and payer acceptance.

Conclusion

VEOZAH’s market dynamics are complex, influenced by regulatory timelines, competitive positioning, and healthcare economics. While its potential for substantial revenue growth exists, success hinges on strategic execution encompassing clinical progress, market penetration, and sustainable pricing. Investors and stakeholders must navigate inherent uncertainties, aligning expectations with the evolving landscape.

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Key Takeaways

• VEOZAH’s commercial success depends on regulatory approvals, with expedited pathways potentially accelerating revenue realization.
• Addressing a high-need therapeutic area and leveraging premium pricing strategies can maximize market opportunity.
• Competitive differentiation and patent protection are critical to maintain market exclusivity and profitability.
• Revenue growth is anticipated to be gradual, with significant scaling occurring post-market adoption, typically within 2-4 years after approval.
• Risks such as regulatory delays, competition, and reimbursement hurdles require proactive management for sustained financial trajectory.

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FAQs

1. When is VEOZAH expected to receive regulatory approval?
Approval timelines depend on clinical trial outcomes and regulator review processes. If phase trials show positive results, regulatory agencies could approve VEOZAH within 12-24 months post-submission, especially with a fast-track designation.

2. What is the target market size for VEOZAH?
The market size largely depends on the indication. For rare diseases, potential patient populations may be fewer than 100,000 globally, but high treatment costs compensate. For more common conditions, the market could reach multi-billion dollars.

3. How does VEOZAH compare with existing therapies?
VEOZAH’s differentiation will depend on efficacy, safety, safety profile, and convenience. Enhanced outcomes or reduced side effects could provide a competitive edge, influencing physician and patient adoption.

4. What are the main risks impacting VEOZAH’s financial trajectory?
Key risks include delayed approval, pricing and reimbursement challenges, competitor entry, patent expirations, and unforeseen safety issues.

5. What are future growth prospects beyond initial market entry?
Opportunities include expanding indications, global market penetration, strategic collaborations, pipeline development, and leveraging real-world data to demonstrate value.

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References

[1] FDA Regulatory Processes. U.S. Food & Drug Administration.
[2] Market Analysis of Rare Disease Treatments. Global Data Reports.
[3] Competitive Strategies in Oncology Drug Market. International Journal of Pharmaceutical Sciences.
[4] Pricing and Reimbursement Trends in Pharmaceuticals. Healthcare Economics Journal.
[5] Forecasting Pharmaceutical Revenue Streams. Pharma Intelligence.