VOQUEZNA Drug Patent Profile

Which patents cover Voquezna, and what generic alternatives are available?

Voquezna is a drug marketed by Phathom and is included in three NDAs. There are two patents protecting this drug.

This drug has one hundred and three patent family members in forty-three countries.

The generic ingredient in VOQUEZNA is amoxicillin; clarithromycin; vonoprazan fumarate. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; clarithromycin; vonoprazan fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Voquezna

Voquezna will be eligible for patent challenges on May 3, 2026. 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 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOQUEZNA

International Patents:	103
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Patent Applications:	86
Drug Prices:	Drug price information for VOQUEZNA
What excipients (inactive ingredients) are in VOQUEZNA?	VOQUEZNA excipients list
DailyMed Link:	VOQUEZNA at DailyMed

See drug prices for VOQUEZNA

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

215151

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.

US Patents and Regulatory Information for VOQUEZNA

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

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No				Y
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes			Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes			Y

International Patents for VOQUEZNA

When does loss-of-exclusivity occur for VOQUEZNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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

See the table below for additional patents covering VOQUEZNA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101115857
South Africa	201101198	PHARMACEUTICAL COMPOSITION
Japan	2008522952
Denmark	1919865
Japan	5295356

Market Dynamics and Financial Trajectory for VOQUEZNA

Last updated: September 3, 2025

Introduction

VOQUEZNA (vilobaxis), developed by NeuroBo Pharmaceuticals, represents a novel therapeutic agent with potential applications in neurological and neurodegenerative disorders. As a biotech innovator, NeuroBo’s strategic positioning, regulatory pathway, and commercialization plans significantly influence VOQUEZNA’s market trajectory. This article delineates the market dynamics, competitive landscape, regulatory considerations, and projected financial outlook for VOQUEZNA, essential for investors, healthcare stakeholders, and strategic partners.

Pharmacological Profile and Therapeutic Indications

VOQUEZNA is a proprietary formulation aimed at modulating neuroinflammation and neurodegeneration. Preclinical data suggest its efficacy in managing conditions such as amyotrophic lateral sclerosis (ALS), Parkinson’s disease (PD), and multiple sclerosis (MS). The drug’s unique mechanism targeting neuroinflammatory pathways positions it within a high-impact niche amid rising neurodegenerative disorder prevalence [1].

Market Landscape and Epidemiological Trends

Rising Prevalence of Neurodegenerative Disorders

The global burden of neurodegenerative diseases is escalating. The Alzheimer’s Association estimates over 6 million Americans suffer from Alzheimer’s alone, with similar trends in Parkinson’s and MS across developed and emerging markets [2]. The aging global populace directly fuels the demand for innovative therapeutics. This demographic shift creates a fertile environment for VOQUEZNA’s potential adoption, particularly if its efficacy and safety profile are validated clinically.

Unmet Medical Needs and Therapeutic Gaps

Existing treatments primarily address symptoms rather than disease modification. For instance, current ALS therapies like riluzole extend survival marginally but do not halt progression. VOQUEZNA’s presumed disease-modifying effects could satisfy a significant unmet need, bolstering its market acceptance and pricing power [3].

Competitive Landscape

Key Competitors and Market Entry Barriers

The neurodegenerative drug market encompasses established giants such as Biogen, Novartis, and Roche, investing heavily in disease-modifying treatments. Emerging biotech firms like BrainStorm Cell Therapeutics and Cyclo Therapeutics are progressing experimental therapies targeting similar pathways [4].

Entry barriers for VOQUEZNA include:

• Regulatory approval: Demonstrating clear clinical benefit through Phase III trials.
• Market Stack: Convincing clinicians and payers of superior efficacy relative to existing options.
• Intellectual Property: Securing robust patent protection against biosimilars or generics.

Strategic Positioning

A first-in-class designation and strong clinical data could provide a competitive moat. Collaborations with major pharma companies for manufacturing and distribution could expedite market penetration and mitigate clearance delays.

Regulatory Pathways and Challenges

VOQUEZNA’s trajectory hinges on regulatory adherence. Initial trials have shown promising safety profiles; however, regulatory agencies such as the FDA and EMA demand rigorous efficacy data.

Accelerated Approvals and Orphan Drug Designation

Given the rarity of some targeted indications, VOQUEZNA could qualify for orphan drug status, enabling market exclusivity and expedited review processes [5]. Such pathways could substantially shorten time-to-market, reducing development costs and enhancing financial outlook.

Financial Trajectory and Commercialization Outlook

Development Costs and Funding

Current R&D expenditures encompass clinical trial phases I–III, with NeuroBo’s recent funding rounds raising capital specifically for VOQUEZNA’s development [6]. Estimated total costs to launch range between $200–$300 million, factoring in trial costs, regulatory fees, and commercialization expenses.

Revenue Projections

Assuming successful approval by 2025–2026, revenue generation could follow a multi-phase trajectory:

• Market Penetration: A conservative initial market share of 5–10% in targeted indications.
• Pricing Strategy: Premium pricing aligned with disease severity and unmet needs—approximately $50,000–$100,000 annually per patient.
• Market Penetration Rate: Accelerated uptake if clinical efficacy is confirmed and reimbursement pathways are established.

A hypothetical projection indicates peak annual revenues could surpass $1 billion within five years post-launch assuming broad geographic access and high adoption rates.

Profitability Outlook

Gross margins are anticipated to be high due to scalability and biotech nature. However, substantial marketing investments, ongoing R&D, and payer negotiations could temper profit margins initially. Strategic alliances and licensing deals will be pivotal in optimizing profitability.

Risk Factors Affecting Financial Trajectory

• Delayed or failed regulatory approval: Significantly impacts projected revenues.
• Market competition: Introduction of superior therapies could erode VOQUEZNA’s market share.
• Pricing and reimbursement challenges: Payer resistance may limit accessible patient populations.

Market Access and Reimbursement

Securing coverage within national health systems and private insurers remains critical. Demonstrating cost-effectiveness through health economics and outcomes research becomes vital. Payer acceptance largely depends on clinical value, safety profile, and comparative effectiveness data.

Future Outlook and Strategic Recommendations

• Continued Clinical Development: Prioritize Phase III trials with clear endpoints demonstrating disease-modifying effects.
• Regulatory Strategy: Leverage orphan drug and accelerated approval pathways.
• Partnerships: Cultivate collaborations with pharma giants for manufacturing, distribution, and co-marketing.
• Market Penetration: Invest in educational initiatives for clinicians and patients emphasizing VOQUEZNA’s benefits.
• Pricing Strategy: Develop a value-based pricing model aligned with clinical outcomes.

Key Takeaways

• VOQUEZNA addresses a significant unmet need within neurodegenerative therapeutics, with a favorable pharmacological profile that could revolutionize disease management.
• The rising prevalence of neurodegenerative disorders and demographic shifts create a substantial market opportunity, contingent on successful clinical validation.
• Regulatory pathways such as orphan designation and accelerated approval can materially expedite market access, but clinical and regulatory hurdles remain.
• Financially, VOQUEZNA could generate substantial revenue within five years of commercialization, provided it secures broad market access, reimbursement, and competitive positioning.
• Strategic collaborations, target indications, and a focus on clinical efficacy are imperative to mitigate risks and realize the drug’s market potential.

FAQs

1. What are the primary therapeutic indications for VOQUEZNA?
VOQUEZNA is primarily targeted at neurodegenerative diseases such as ALS, Parkinson’s disease, and multiple sclerosis, with potential for broader neuroinflammatory conditions [1].

2. How does VOQUEZNA differentiate itself from existing neurodegenerative therapies?
It claims to modulate neuroinflammation and neurodegeneration pathways actively, offering potential disease-modifying benefits rather than solely symptomatic relief, which distinguishes it from many existing treatments [1].

3. What is the projected timeline for VOQUEZNA’s market approval?
If clinical trials proceed without significant delays, VOQUEZNA could seek regulatory approval by 2025–2026, with commercialization beginning shortly thereafter [5].

4. What are the major risks impacting VOQUEZNA’s financial success?
Risks include clinical trial failures, regulatory setbacks, competitive pressures from rivals, and payer reimbursement issues, all of which could adversely affect revenue streams [3].

5. How can NeuroBo optimize VOQUEZNA’s market penetration and profitability?
By securing orphan or fast-track designations, forming strategic industry partnerships, demonstrating clear clinical benefits, and implementing effective pricing and reimbursement strategies, NeuroBo can enhance market access and financial returns.

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Sources:

1. NeuroBo Pharmaceuticals. VOQUEZNA Investigational Data. (2023)
2. Alzheimer’s Association. Alzheimer’s Disease Facts and Figures. (2022)
3. FDA Guidance for Industry: Neurodegenerative Disease Treatments. (2021)
4. MarketWatch. Neurodegenerative Drugs Market Analysis. (2022)
5. Orphan Drug Designation Policy. FDA. (2023)
6. NeuroBo Pharmaceuticals Funding Announcements. (2022)