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 was eligible for patent challenges on May 3, 2026.

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
Clinical Trials:	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.

Recent Clinical Trials for VOQUEZNA TRIPLE PAK

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all VOQUEZNA TRIPLE PAK clinical trials

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
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes

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
Argentina	055144
Argentina	107852
Austria	E504567
Australia	2006285641
Brazil	122017028096

# Voquezna Triple Pak Market Dynamics and Financial Trajectory

Last updated: August 2, 2026

Voquezna Triple Pak is Phathom Pharmaceuticals’ fixed treatment regimen for Helicobacter pylori infection, combining vonoprazan 20 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg twice daily for 14 days. The FDA approved it in May 2022. Its commercial opportunity is tied to the large H. pylori eradication market, but its revenue contribution is not separately disclosed from other Voquezna products. Phathom’s financial trajectory therefore depends primarily on the broader Voquezna franchise, including Voquezna Dual Pak and vonoprazan monotherapy for acid-related disorders.

Triple Pak has a differentiated mechanism and dosing profile, but its market share is constrained by clarithromycin resistance, competition from generic antibiotic regimens, payer controls, and the need for physician adoption. The larger financial catalyst is the expansion of vonoprazan into gastroesophageal reflux disease, where the addressable market is materially larger than H. pylori treatment.

What is Voquezna Triple Pak and how does it work?

Voquezna Triple Pak contains:

Component	Dose	Role
Vonoprazan fumarate	20 mg twice daily	Potassium-competitive acid blocker
Amoxicillin	1,000 mg twice daily	Antibiotic
Clarithromycin	500 mg twice daily	Antibiotic
Treatment duration	14 days	H. pylori eradication

The regimen suppresses gastric acid through vonoprazan and treats the infection with two antibiotics. Unlike traditional proton-pump-inhibitor triple therapy, vonoprazan provides rapid and sustained acid suppression without requiring activation in an acidic environment.

The FDA approved Voquezna Triple Pak for adults with H. pylori infection. The same approval also covered Voquezna Dual Pak, which combines vonoprazan with amoxicillin and avoids clarithromycin exposure. The products are prescription therapies marketed by Phathom Pharmaceuticals in the United States (U.S. Food and Drug Administration, 2022).

When was Voquezna Triple Pak approved and launched?

The FDA approved Voquezna Triple Pak on May 3, 2022. The approval followed clinical data showing H. pylori eradication rates superior to standard proton-pump-inhibitor-based triple therapy in the relevant trial population.

The commercial timeline is:

Date	Event
May 3, 2022	FDA approval of Voquezna Triple Pak and Dual Pak for H. pylori infection
2022	Initial U.S. commercialization of the H. pylori products
November 1, 2023	FDA approval of Voquezna tablets for erosive GERD and related acid-mediated indications
January 2024	Commercial expansion of the Voquezna franchise into GERD
2024 onward	Revenue focus shifts from H. pylori regimens toward the broader vonoprazan market

The 2023 GERD approval changed the commercial profile of the product family. Triple Pak remains an important approved product, but its market is a finite-course treatment market. GERD creates a larger recurring-prescription opportunity.

How large is the Voquezna Triple Pak market?

The commercial market has three demand drivers:

1. The prevalence of H. pylori infection.
2. Diagnosis and treatment rates.
3. Physician selection of branded vonoprazan-based therapy over low-cost generic regimens.

H. pylori infection affects a substantial share of the global population, although prevalence varies widely by geography, age, socioeconomic status, and diagnostic practices. In the United States, the addressable treated population is smaller than the total infected population because many patients remain undiagnosed or receive empiric therapy.

Triple Pak competes against:

• Bismuth quadruple therapy.
• Rifabutin-based triple therapy.
• Concomitant therapy.
• Clarithromycin-based proton-pump-inhibitor triple therapy.
• Vonoprazan-amoxicillin Dual Pak.
• Generic combinations prescribed as separate products.

The key market distinction is that Triple Pak is a branded co-packaged regimen, while many alternatives are assembled from inexpensive generic drugs. Its commercial value depends on the clinical and operational benefits of vonoprazan being sufficient to justify the branded price.

How does Voquezna Triple Pak compare with Voquezna Dual Pak?

Dual Pak is strategically important because it addresses antibiotic-resistance concerns associated with clarithromycin. Triple Pak includes clarithromycin and can be less attractive where macrolide resistance is prevalent or prior macrolide exposure is known.

Attribute	Voquezna Triple Pak	Voquezna Dual Pak
Acid suppression	Vonoprazan	Vonoprazan
Antibiotics	Amoxicillin plus clarithromycin	Amoxicillin only
Dosing complexity	Two doses daily	Amoxicillin three times daily
Clarithromycin exposure	Yes	No
Resistance positioning	More vulnerable to clarithromycin resistance	Avoids clarithromycin resistance
Commercial role	Established branded H. pylori regimen	Resistance-oriented alternative

Triple Pak has a simpler antibiotic dosing schedule than Dual Pak, but Dual Pak has a clinical positioning advantage where clarithromycin resistance is a concern. Phathom can therefore market both products across different treatment preferences rather than relying on one H. pylori regimen.

What is the FDA and Orange Book status of Voquezna Triple Pak?

Voquezna Triple Pak is an FDA-approved prescription product for H. pylori eradication. The product is listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, under the relevant Voquezna product entries.

The regulatory position has several commercial implications:

• Triple Pak is an approved branded drug product, not an unapproved combination pack.
• The FDA label establishes the approved H. pylori indication and dosing.
• The product contains multiple active ingredients, but vonoprazan is the principal differentiated component.
• Generic competition may arise through abbreviated new drug applications, product-specific challenges, or separate generic components rather than a direct copy of the entire co-pack.
• The later GERD approval expands the commercial relevance of vonoprazan patents and manufacturing capabilities beyond the H. pylori indication.

FDA approval does not guarantee market exclusivity for every component of the package. Commercial protection depends on the applicable patents, regulatory exclusivity, product configuration, and the legal route used by a competitor.

What patents protect Voquezna Triple Pak?

The strongest intellectual-property value is generally concentrated in vonoprazan-related rights rather than the older antibiotic ingredients. Amoxicillin and clarithromycin are long-established generic antibiotics with extensive prior art and limited standalone exclusivity value.

Relevant protection categories include:

Protection category	Commercial relevance
Vonoprazan compound and pharmaceutical composition patents	Protect the active acid-suppression agent
Vonoprazan formulation patents	May protect dosage form, stability, salt, or release characteristics
Combination patents	May cover vonoprazan with antibiotics for H. pylori treatment
Method-of-use patents	May cover treatment of H. pylori or acid-related disorders
Manufacturing and process patents	Can increase supply-chain and formulation barriers
Regulatory exclusivity	Provides time-limited protection independent of patent validity

The patent estate is more valuable when it covers the vonoprazan product used across multiple indications. A patent that protects only a finite-course H. pylori regimen has less economic reach than a patent covering chronic GERD treatment.

Patent expiration and Orange Book listing details should be evaluated at the individual patent and product level. The relevant risk is not simply whether a vonoprazan patent exists, but whether a generic applicant can avoid the listed claims through a Paragraph III certification, Paragraph IV certification, formulation change, different labeling, or separate-component strategy.

When does Voquezna Triple Pak lose exclusivity?

Triple Pak’s commercial exclusivity is unlikely to end on a single date because its protection can consist of multiple patents, regulatory periods, and product-specific rights.

Potential loss-of-exclusivity events include:

• Expiration of key vonoprazan composition patents.
• Expiration of formulation or combination patents.
• Successful Paragraph IV litigation.
• Approval of a competing vonoprazan product.
• Generic substitution involving the individual antibiotic components.
• Payer decisions that favor lower-cost H. pylori regimens.
• Clinical guidelines that shift away from clarithromycin-containing treatment.

The effective commercial loss date may occur before the final patent expiration if a competitor launches at risk, receives a favorable court ruling, settles for an earlier entry date, or gains reimbursement sufficient to displace the branded product.

Which companies are challenging Voquezna Triple Pak?

Publicly disclosed competitive risk comes from several categories rather than one dominant challenger.

Generic pharmaceutical companies

Generic manufacturers can challenge the product through abbreviated applications or market the component antibiotics separately. The principal targets are the branded vonoprazan component, the co-pack configuration, and the approved labeling.

Branded gastrointestinal companies

Companies selling acid-suppression therapies compete for the same prescribers and payer budgets. Vonoprazan competes with proton-pump inhibitors, potassium-competitive acid blockers, and combination regimens.

Alternative H. pylori regimens

Bismuth quadruple therapy and rifabutin-based regimens are clinically important alternatives. Their use can increase when physicians seek to avoid clarithromycin resistance.

No publicly disclosed settlement or Paragraph IV outcome should be treated as established without a current docket and Orange Book review. The commercial risk can exist even where no major litigation has been publicly reported.

What is the financial trajectory of Voquezna Triple Pak?

Phathom does not separately report revenue for Voquezna Triple Pak, Voquezna Dual Pak, and vonoprazan tablets. Its public financial statements report revenue at the broader Voquezna product-family level. As a result, Triple Pak’s standalone sales, gross margin, and prescription volume cannot be isolated from SEC filings.

The financial trajectory has four phases:

Phase	Financial characteristic
2022 approval and launch	Initial H. pylori revenue and commercial investment
2023 market development	Expansion of physician awareness and payer coverage
2024 GERD expansion	Larger recurring-prescription opportunity
2025 and later	Franchise economics depend on GERD penetration, pricing, and patent durability

Triple Pak generates finite-course revenue. A patient treated for 14 days does not produce the recurring revenue associated with chronic GERD therapy. Its strategic value is therefore partly commercial and partly promotional: H. pylori prescriptions introduce physicians and payers to vonoprazan before or alongside the larger GERD opportunity.

Key financial variables include:

• Net product revenue for the full Voquezna franchise.
• Gross-to-net deductions from rebates, discounts, and patient assistance.
• Prescription growth after the GERD launch.
• Commercial and medical-affairs spending.
• Payer coverage and prior-authorization requirements.
• Manufacturing cost for vonoprazan and co-packaged products.
• Cash consumption before the product reaches operating profitability.
• Potential licensing, partnering, or acquisition transactions involving vonoprazan.

How strong is the commercial position of Voquezna Triple Pak?

Triple Pak has a credible clinical position but a narrower financial profile than chronic vonoprazan therapy.

Its advantages are:

• FDA-approved vonoprazan-based H. pylori treatment.
• Convenient co-packaged dosing.
• Stronger acid suppression than conventional proton-pump-inhibitor regimens.
• Brand recognition from the broader Voquezna franchise.
• Potential use in patients requiring an alternative to traditional therapy.

Its constraints are:

• Clarithromycin resistance.
• Generic competition.
• Short treatment duration.
• Limited standalone revenue transparency.
• Payer pressure on branded combination products.
• Dependence on physician recognition of the clinical value of vonoprazan.

The product is commercially stronger as part of a vonoprazan platform than as a standalone H. pylori product.

What generic launch scenarios exist for Voquezna Triple Pak?

Three launch scenarios are commercially relevant:

1. A direct generic co-pack enters after patent or regulatory barriers fall.
2. A generic vonoprazan product enters while antibiotics remain separately sourced.
3. Generic competitors use alternative labeling or formulations to avoid key claims.

The first scenario creates the greatest direct pricing pressure. The second may erode the economic value of the branded package while preserving some clinical demand for vonoprazan. The third can produce gradual share loss rather than an immediate collapse.

Phathom’s defense would depend on enforceable patent claims, manufacturing scale, contracting, brand loyalty, clinical guidelines, and the ability to shift demand toward protected or newer vonoprazan indications.

What is the geographic coverage and manufacturing risk?

Voquezna Triple Pak’s principal commercial market is the United States, where Phathom owns the commercial franchise. The company’s opportunity outside the United States depends on licensing, regional commercialization rights, regulatory approvals, and local reimbursement.

Manufacturing risk includes:

• Dependence on vonoprazan active pharmaceutical ingredient supply.
• Co-packaging and quality-control requirements.
• Separate sourcing of amoxicillin and clarithromycin.
• Inventory management for a finite-course product.
• Product-specific supply interruptions.
• Regulatory compliance across multiple manufacturing sites.

The antibiotic ingredients are widely available, but vonoprazan is the differentiated supply component. Any disruption affecting vonoprazan production would affect Triple Pak, Dual Pak, and monotherapy products simultaneously.

Key Takeaways

• Voquezna Triple Pak was FDA-approved in May 2022 for adult H. pylori eradication.
• It combines vonoprazan, amoxicillin, and clarithromycin for 14 days.
• Triple Pak revenue is not separately disclosed; Phathom reports the broader Voquezna franchise.
• Its market is constrained by clarithromycin resistance and low-cost generic alternatives.
• Dual Pak provides a strategically important clarithromycin-free alternative.
• The larger financial opportunity is chronic vonoprazan treatment for GERD.
• Patent value is concentrated in vonoprazan composition, formulation, combination, and method-of-use rights.
• Generic entry risk depends on patent scope, Orange Book listings, Paragraph IV activity, and the competitive route used by applicants.
• Triple Pak is commercially important as both a treatment product and an entry point into the broader Voquezna franchise.

FAQs

Is Voquezna Triple Pak still commercially important after the GERD approval?

Yes. It provides an approved H. pylori treatment and supports physician familiarity with vonoprazan, although chronic GERD therapy offers greater recurring-revenue potential.

Does Voquezna Triple Pak contain a proton-pump inhibitor?

No. It contains vonoprazan, a potassium-competitive acid blocker, together with amoxicillin and clarithromycin.

Is Voquezna Triple Pak interchangeable with generic antibiotics?

No. Generic antibiotics can be prescribed separately, but they are not automatically therapeutically equivalent to the branded co-packaged regimen.

Does clarithromycin resistance reduce the value of Voquezna Triple Pak?

Yes. Resistance can reduce the clinical attractiveness of clarithromycin-containing regimens and increase demand for Dual Pak or non-clarithromycin alternatives.

Is Phathom’s revenue from Voquezna Triple Pak publicly available?

No separate Triple Pak revenue figure is reported in the company’s public financial disclosures. Reported product revenue covers the broader Voquezna portfolio.

References

1. U.S. Food and Drug Administration. (2022, May 3). FDA approves new treatment for Helicobacter pylori infection. https://www.fda.gov
2. U.S. Food and Drug Administration. (2023, November 1). FDA approves Voquezna tablets for the treatment of erosive gastroesophageal reflux disease and other acid-related conditions. https://www.fda.gov
3. U.S. Food and Drug Administration. (n.d.). Voquezna Triple Pak prescribing information. https://www.accessdata.fda.gov
4. Phathom Pharmaceuticals, Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission. https://www.sec.gov
5. American College of Gastroenterology. (2024). ACG clinical guideline: Treatment of Helicobacter pylori infection. The American Journal of Gastroenterology.