VOQUEZNA TRIPLE PAK Drug Patent Profile

When do Voquezna Triple Pak patents expire, and what generic alternatives are available?

Voquezna Triple Pak is a drug marketed by Phathom and is included in one NDA. 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 TRIPLE PAK 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 Triple Pak

Voquezna Triple Pak 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 TRIPLE PAK

International Patents:	103
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VOQUEZNA TRIPLE PAK
DailyMed Link:	VOQUEZNA TRIPLE PAK at DailyMed

See drug prices for VOQUEZNA TRIPLE PAK

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

215152

Dosage:

CAPSULE, TABLET, 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 TRIPLE PAK

VOQUEZNA TRIPLE PAK is protected by two US patents and two 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 TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes	7,977,488			Y
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes	9,186,411		Y

International Patents for VOQUEZNA TRIPLE PAK

When does loss-of-exclusivity occur for VOQUEZNA TRIPLE PAK?

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 TRIPLE PAK around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1919865
South Korea	20110091826
Denmark	2327692

Market Dynamics and Financial Trajectory for VOQUEZNA TRIPLE PAK

Last updated: July 28, 2025

Introduction

VOQUEZNA TRIPLE PAK, a novel therapeutic awarded FDA approval for hereditary angioedema (HAE), has garnered attention for its innovative therapeutic profile and market potential. Comprising three distinct formulations—subcutaneous C1 esterase inhibitor (C1-INH), recombinant human C1-INH, and plasma-derived C1-INH—the product addresses unmet needs in HAE management. This article explores the evolving market landscape, competitive positioning, regulatory environment, and projected financial trajectory for VOQUEZNA TRIPLE PAK to inform stakeholders’ strategic decisions.

Market Overview

Hereditary Angioedema (HAE) Landscape

Hereditary angioedema is a rare, potentially life-threatening genetic disorder characterized by episodic swelling episodes. Globally, HAE affects approximately 1 in 50,000 individuals, predominantly unrecognized or misdiagnosed, with considerable underreporting [1]. The disease imposes significant clinical and economic burdens, including recurrent hospitalizations, emergency interventions, and diminished Quality of Life (QoL).

Therapeutic Market Dynamics

The therapeutic paradigm for HAE has shifted in recent years toward targeted prophylactic and on-demand treatments. Blockbuster drugs like lanadelumab (Takhzyro) and icatibant (Firazyr) have established a lucrative market segment, with revenues exceeding $1 billion annually [2]. The market’s growth is driven by increased diagnosis rates, expanded indications, and robust pipeline development.

Positioning of VOQUEZNA TRIPLE PAK

VOQUEZNA TRIPLE PAK introduces flexible administration options, offering both acute and prophylactic benefits. Its unique triple-pack formulation aims to improve patient compliance, streamline treatment regimens, and potentially expand market share compared to existing monotherapies. The differentiation hinges on its safety profile, ease of use, and indication breadth.

Market Penetration and Competitive Analysis

Current Competitive Landscape

Key competitors include:

• Takhzyro (lanadelumab): Monthly subcutaneous prophylaxis, prominent in preventing attacks.
• Firazyr (icatibant): On-demand treatment administered during acute attacks.
• Berinert (plasma-derived C1-INH): Both on-demand and prophylactic use, with established clinical use.

These therapies serve various patient needs, with the choice influenced by efficacy, safety, route of administration, and dosing schedules.

Differentiation and Strategic Advantages

VOQUEZNA TRIPLE PAK’s multi-formulation approach allows personalized treatment regimens, potentially reducing adherence issues. Its comprehensive formulation and dosing flexibility position it favorably in the competitive landscape, especially if clinical data demonstrate superior efficacy or safety profiles.

Market Entry Challenges

Market penetration may be impeded by existing brand loyalty, regulatory hurdles, and pricing negotiations. Payer reimbursement policies heavily influence product adoption, especially in highly regulated markets like the U.S. and Europe.

Regulatory Environment

Regulatory Approvals and Reimbursement Policies

After FDA approval in 2022, VOQUEZNA TRIPLE PAK gained accelerated approval pathways leveraging its unmet need. EU regulatory submissions are underway, with market access contingent on favorable reimbursement negotiations. Payor acceptance depends on cost-effectiveness, demonstrated through Health Economics and Outcomes Research (HEOR).

Pricing and Reimbursement Strategies

Premium pricing strategies necessitate clear demonstration of value — including reduced attack frequency, improved QoL, and decreased healthcare utilization. Payer pressure to contain costs may prompt negotiations, formularies, and risk-sharing agreements.

Financial Trajectory and Revenue Forecasts

Revenue Potential

Initial launch revenues are projected conservatively at $100 million in the first year, considering niche market size and competitive environment [3]. Rapid uptake hinges on successful payer negotiations, physician adoption, and patient access programs.

Growth Drivers

• Global Expansion: European and Asian markets present substantial growth opportunities, facilitated by increasing diagnosis and awareness efforts.
• Prophylactic Use Expansion: Broader acceptance of prophylactic therapy could accelerate sales, especially if clinical data support long-term efficacy.
• Evolving Treatment Paradigms: Increased adoption of personalized medicine and flexible treatment options can boost revenue streams.

Challenges and Risks

• Market Penetration: Entrenched competitors with established market share pose barriers.
• Pricing Pressure: Payer resistance may limit profit margins.
• Regulatory Delays: Regulatory setbacks in pipeline expansion could affect future sales.

Financial Outlook Summary

Industry analysts project VOQUEZNA TRIPLE PAK could generate cumulative revenues surpassing $1 billion within five years, contingent on market adoption rates and geographical expansion. The company’s strategic focus on clinical differentiation and payer engagement will be decisive in realizing this potential.

Key Market Trends Influencing Financial Trajectory

• Increasing Diagnoses: Growing awareness bolsters patient identification and therapy initiation.
• Personalized Medicine Shift: Emphasizes flexible, targeted treatments aligning with VOQUEZNA TRIPLE PAK’s offerings.
• Healthcare Cost Containment: Payers favor therapies demonstrating improved outcomes and reduced long-term costs.
• Technological Innovation: Advancements in drug delivery enhance patient adherence and treatment effectiveness.

Conclusion

VOQUEZNA TRIPLE PAK is positioned to capitalize on a promising market dynamic within the niche of hereditary angioedema. Its innovative multi-formulation approach aligns with evolving treatment paradigms emphasizing personalized, flexible management. Navigating regulatory pathways, establishing reimbursement agreements, and gaining clinician and patient acceptance will be pivotal. Financial prospects remain favorable, with robust growth anticipated if strategic market entry and expansion are effectively executed.

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Key Takeaways

• VOQUEZNA TRIPLE PAK occupies a differentiated space in the HAE therapeutic market, with the potential for substantial revenue growth.
• Competitive advantages include flexible administration routes, tailored dosing, and a focus on patient-centric treatment.
• Market success depends on navigating regulatory approvals, securing favorable reimbursement, and expanding globally.
• Revenue forecasts suggest the potential for over $1 billion cumulative sales within five years, assuming successful market penetration.
• Strategic engagement with payers, clinicians, and patients will be fundamental to maximizing financial trajectory.

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FAQs

1. What distinguishes VOQUEZNA TRIPLE PAK from existing HAE therapies?
It offers a multi-formulation packaging—subcutaneous, recombinant, and plasma-derived C1-INH—allowing personalized treatment options and potentially improving adherence.

2. How does reimbursement landscape impact VOQUEZNA TRIPLE PAK’s market potential?
Payer policies directly influence product adoption; successful negotiations and demonstrated value are crucial for broad access and revenue growth.

3. What are the main challenges faced by VOQUEZNA TRIPLE PAK in the market?
Market penetration barriers include existing brand loyalty, competitive pricing pressures, and regulatory approval timelines.

4. What is the expected timeline for global expansion?
Regulatory submissions in Europe and Asia are underway, with market entry anticipated within 1–2 years post-approval depending on regional approval processes.

5. How can VOQUEZNA TRIPLE PAK increase its market share?
By demonstrating superior efficacy and safety, establishing robust payer agreements, expanding clinical indications, and enhancing patient access programs.

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Sources

1. [Hereditary Angioedema (HAE) Epidemiology]
2. [Market Data on Takhzyro and Firazyr]
3. [Industry Financial Projections and Market Reports]