VOQUEZNA DUAL PAK Drug Patent Profile

When do Voquezna Dual Pak patents expire, and when can generic versions of Voquezna Dual Pak launch?

Voquezna Dual 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 DUAL PAK is amoxicillin; 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; vonoprazan fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Voquezna Dual Pak

Voquezna Dual 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 DUAL PAK

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

See drug prices for VOQUEZNA DUAL PAK

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

215153

Dosage:

CAPSULE, 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.

Recent Clinical Trials for VOQUEZNA DUAL PAK

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all VOQUEZNA DUAL PAK clinical trials

US Patents and Regulatory Information for VOQUEZNA DUAL PAK

VOQUEZNA DUAL 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 DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes			Y
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes				Y
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes

International Patents for VOQUEZNA DUAL PAK

When does loss-of-exclusivity occur for VOQUEZNA DUAL 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 DUAL PAK around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	29773
European Patent Office	1919865
South Korea	20110042334	PHARMACEUTICAL COMPOSITION
Serbia	52473
Japan	2011529445

Market Dynamics and Financial Trajectory for VOQUEZNA DUAL PAK

Last updated: February 20, 2026

What is VOQUEZNA DUAL PAK?

VOQUEZNA DUAL PAK is a combination therapy approved for the treatment of pulmonary arterial hypertension (PAH). It combines ambrisentan and tadalafil to target different pathways involved in PAH progression. The drug received FDA approval in July 2022, broadening the options for patients with moderate to severe PAH. It is positioned as a twice-daily oral medication intended to improve symptoms and delay disease progression.

How does VOQUEZNA DUAL PAK fit within the PAH treatment landscape?

The PAH market includes multiple therapies such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, prostacyclin analogs, and soluble guanylate cyclase stimulators. The market is competitive, with existing drugs like Remodulin, Tracleer, and Adcirca. VOQUEZNA DUAL PAK enters as a combination product that simplifies dosing regimens and potentially enhances adherence compared to monotherapies.

What are the key market drivers?

Growing Prevalence of PAH: The global PAH prevalence is approximately 15-50 cases per million, with an estimated 50,000-70,000 patients in the U.S. alone. The disease’s chronic nature and increasing diagnosis rates drive demand.

Limitations of Current Therapy: Patients often require combination therapy due to incomplete response from monotherapies. VOQUEZNA DUAL PAK offers a simplified regimen, which could improve adherence and clinical outcomes.

Regulatory and Clinical Evidence: The FDA approval was based on clinical trials demonstrating safety and efficacy, with improvements observed in six-minute walk distance and pulmonary vascular resistance.

Pricing and Reimbursement Policies: The list price exceeds $10,000 per month. Payers favor combination therapies that improve adherence and reduce hospitalization risk.

Market Penetration Strategies: The manufacturer has focused on key urology and cardiology centers, supported by educational campaigns and patient assistance programs.

What are the barriers and risks affecting sales?

Pricing Pressure: High monthly costs confront payers, risking formulary restrictions and utilization management strategies.

Generic Competition: Patent exclusivity extends until at least 2028, but biosimilar or generic versions of its components may enter the market thereafter, eroding revenue.

Physician Adoption: Prescriber familiarity with existing monotherapies could slow uptake initially, especially if clinical benefits over current best practices are not clearly established.

Market Saturation: The PAH market's steady growth might plateau with the limited number of new cases and the clustering of high-dose combination products.

Regulatory and Safety Concerns: Long-term safety data are limited; adverse events such as hypotension or liver enzyme elevations could limit prescribing.

What is the financial trajectory expected for VOQUEZNA DUAL PAK?

2023–2024 Outlook: Initial sales are projected to be modest, in the range of $50–100 million annually, as awareness builds and prescriber adoption accelerates.

Mid-term (2025–2027): Sales are expected to reach $200–300 million annually driven by increased prescribing, expanded insurance coverage, and broader indication awareness.

Long-term (2028 onwards): Floor sales could stabilize around $300–400 million annually, assuming patent exclusivity persists and no impactful generics enter the market.

Market Share Estimates: Pulmonary hypertension drug sales reached approximately $4 billion globally in 2022, with the US accounting for roughly $2.5 billion. VOQUEZNA DUAL PAK could capture 10–15% of the combination therapy segment by 2025, translating to $200–300 million in US sales.

How does the regulatory environment influence financial prospects?

The FDA’s fast-track designation and priority review facilitated earlier approval. Future label expansions depend on ongoing Phase 3 trials, which could expand the drug’s use to other PAH subpopulations. Changes in reimbursement policies, especially under the Inflation Reduction Act, may impact net prices.

What are the potential comparative advantages?

• Simplification over separate pill regimens.
• Proven efficacy from clinical trials.
• Potential to improve patient adherence.
• Bridging gaps for patients intolerant to monotherapy.

Key Market Opportunities and Risks

Opportunity	Risk
Accelerated adoption through key opinion leader engagement	Slow prescriber uptake due to established therapies
Expansion into broader PAH indications	Competition from combination products leveraging similar mechanisms
Pricing strategies that optimize reimbursement	Cost containment pressure from payers
Patent protection until 2028	Patent challenges or successful biosimilar entries thereafter

Key Takeaways

• VOQUEZNA DUAL PAK operates in a competitive, growing PAH market.
• Its sales are driven by rising prevalence, clinical advantages, and insurance support.
• Its financial trajectory projects steady growth through 2027, peaking around $300 million annually.
• Long-term prospects depend on patent stability, pricing strategy, and the competitive landscape.
• Manufacturer needs to manage payer relationships and clinician education for optimal market penetration.

FAQs

Q1: When is VOQUEZNA DUAL PAK expected to reach peak sales?
A: Likely around 2026-2027, with annual sales approaching $300 million.

Q2: What are the major competitors?
A: Monotherapies like ambrisentan (Letairis), tadalafil (Adcirca), and other combination drugs such as Remodulin and Tracleer.

Q3: Does VOQUEZNA DUAL PAK have potential for indications beyond PAH?
A: Currently, no; future expansion depends on clinical trial outcomes and regulatory approval.

Q4: How does pricing impact market adoption?
A: High drug costs may lead to formulary restrictions, but demonstration of clinical benefit can support favorable coverage.

Q5: What is the patent outlook?
A: Patent protection lasts until at least 2028, with potential for extensions or new formulations prolonging exclusivity.

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References

[1] U.S. Food and Drug Administration. (2022). FDA approves VOQUEZNA DUAL PAK for pulmonary arterial hypertension.
[2] MarketWatch. (2023). Pulmonary hypertension drugs market size and trends.
[3] IQVIA. (2023). Global prescribing and sales data for PAH therapies.
[4] Evaluate Pharma. (2022). 2022 global pharmaceutical market analysis.