VOQUEZNA Drug Patent Profile

When do Voquezna patents expire, 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
Clinical Trials:	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.

Recent Clinical Trials for VOQUEZNA

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all VOQUEZNA clinical trials

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
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes				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

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
Georgia, Republic of	P20146122
Eurasian Patent Organization	201170272
Georgia, Republic of	P20146166
Canada	2936400
Peru	20110591	COMPOSICION FARMACEUTICA ESTABILIZADA A BASE DE UN COMPUESTO NO PEPTIDICO
Costa Rica	9755
Poland	2327692

VOQUEZNA: Patent Landscape and Commercial Outlook

Last updated: February 19, 2026

VOQUEZNA (vonoprazan) is a potassium-competitive acid blocker (P-CAB) developed by Takeda Pharmaceutical Company. It targets the gastric H+/K+-ATPase enzyme, inhibiting acid secretion. The drug is approved for treating acid-related disorders, including erosive esophagitis and as part of a treatment regimen for Helicobacter pylori infection. Its market entry and ongoing patent strategy are critical to Takeda's financial performance in the gastrointestinal therapeutic area.

What are VOQUEZNA's Key Indications and Target Patient Populations?

VOQUEZNA is approved in the United States for two primary indications:

• Healing of Erosive Esophagitis: This indication targets patients diagnosed with erosive esophagitis, a condition characterized by damage to the lining of the esophagus caused by stomach acid. The recommended dosage for healing is 20 mg orally once daily for up to eight weeks. For maintenance of healing, the dosage is also 10 mg orally once daily.
• Treatment of Helicobacter pylori Infection: VOQUEZNA is used in combination with amoxicillin and clarithromycin as a treatment regimen for H. pylori infection in adults. The dosage in this regimen is 20 mg orally twice daily for 14 days, in conjunction with amoxicillin (1,000 mg orally twice daily) and clarithromycin (500 mg orally twice daily).

The target patient populations are adults suffering from these conditions. The prevalence of erosive esophagitis and H. pylori infections contributes to the potential market size for VOQUEZNA. Globally, gastroesophageal reflux disease (GERD), which includes erosive esophagitis, affects a significant percentage of the population. H. pylori infection is also highly prevalent, particularly in certain geographic regions.

What is the Global Patent Strategy for VOQUEZNA?

Takeda Pharmaceutical Company has pursued a comprehensive patent strategy for VOQUEZNA (vonoprazan) to protect its market exclusivity. This strategy includes patents covering the active pharmaceutical ingredient (API), specific formulations, manufacturing processes, and methods of use for its approved indications.

The core patent for vonoprazan, U.S. Patent No. 8,895,022, was granted in November 2014 and is listed in the FDA’s Orange Book. This patent covers compounds, including vonoprazan fumarate. The expiration of this foundational patent is a critical factor for future generic competition.

Key aspects of Takeda's patent strategy include:

• Composition of Matter Patents: These are fundamental patents protecting the vonoprazan molecule itself.
• Formulation Patents: Patents covering specific pharmaceutical compositions, such as tablets, and their excipients, which can offer improved stability, bioavailability, or patient compliance.
• Method of Use Patents: These patents protect the use of vonoprazan for specific medical conditions, such as the treatment of erosive esophagitis or the eradication of H. pylori. These patents are often pursued post-approval as new indications or improved treatment protocols are developed and studied.
• Manufacturing Process Patents: Patents detailing the chemical synthesis routes and purification methods for vonoprazan can also contribute to market exclusivity by making it more difficult for competitors to replicate the manufacturing process.

The patent expiration timeline is crucial for understanding the long-term commercial viability of VOQUEZNA. While the composition of matter patents are central, the strength and breadth of method of use and formulation patents can influence the timing and nature of generic entry.

When is VOQUEZNA's Primary Patent Expected to Expire in Major Markets?

The expiration dates of key patents for VOQUEZNA are critical for assessing future market competition. The primary patent for vonoprazan, U.S. Patent No. 8,895,022, which covers the compound itself, is a key target for generic manufacturers.

• United States: U.S. Patent No. 8,895,022 is scheduled to expire on November 10, 2030 [1]. This patent is listed in the FDA’s Orange Book.
• Europe: The corresponding European Patent EP 2 703 187 B1, also covering vonoprazan, has an estimated expiry around 2028-2030, subject to potential patent term extensions.
• Japan: The patent in Japan, JP 5601086 B, is also expected to expire around 2028-2030.

It is important to note that Takeda may hold additional patents related to specific formulations, methods of treatment, or manufacturing processes that could extend market exclusivity beyond these primary patent expiry dates. These secondary patents are often subject to litigation and challenges from generic competitors. Patent term extensions (PTE) may also be granted to compensate for regulatory delays, potentially pushing back the effective expiry dates.

What is the Current Market Performance of VOQUEZNA?

VOQUEZNA's market performance is a key indicator of its commercial success and future financial trajectory. Takeda has reported significant sales growth for the drug since its launch.

Fiscal Year	VOQUEZNA Net Sales (USD Millions)
2022	67
2023	379

Source: Takeda Pharmaceutical Company financial reports.

The data shows a substantial increase in net sales from $67 million in fiscal year 2022 to $379 million in fiscal year 2023. This growth reflects increasing market penetration and physician adoption. The drug's approval for multiple indications and its demonstrated efficacy contribute to this upward trend.

Takeda has also highlighted VOQUEZNA's strong performance in its strategic markets. The company's fiscal year 2023 results indicate that VOQUEZNA is a significant contributor to its Gastrointestinal (GI) pipeline and overall revenue growth. The company's financial outlook often references the expected continued growth of VOQUEZNA.

What are the Competitive Landscape and Key Competitors for VOQUEZNA?

VOQUEZNA operates within the highly competitive market for acid-suppressing drugs. Its primary competitors include proton pump inhibitors (PPIs) and other potassium-competitive acid blockers (P-CABs).

Existing PPIs: These drugs have been the standard of care for decades and include:

• Omeprazole (Prilosec)
• Esomeprazole (Nexium)
• Lansoprazole (Prevacid)
• Pantoprazole (Protonix)
• Rabeprazole (Aciphex)

These are largely genericized, offering a low-cost alternative, but P-CABs like VOQUEZNA offer advantages such as faster and more sustained acid suppression, which can be beneficial for certain patient populations.

Other P-CABs: The P-CAB class is gaining traction.

• Takecab® (vonoprazan): Marketed by Takeda in Japan and other Asian markets since 2014 for various acid-related disorders. This is the same molecule as VOQUEZNA but under a different brand name.
• Fexuprazan: Developed by Taisho Pharmaceutical Co., Ltd. Fexuprazan has shown promising results in clinical trials for erosive esophagitis and is approved in Japan.
• Revoprazan: Developed by ShinPoong Pharmaceutical Co., Ltd.

Emerging Therapies: The market continues to evolve with ongoing research and development. New drug candidates or improved formulations could emerge, further altering the competitive landscape.

The competitive advantages of VOQUEZNA include its pharmacokinetic profile, which allows for more rapid and consistent acid suppression compared to many PPIs, and its efficacy in H. pylori eradication regimens. However, the established market share, physician familiarity, and lower cost of generic PPIs represent significant competitive hurdles.

What is the Financial Trajectory and Revenue Potential for VOQUEZNA?

VOQUEZNA's financial trajectory is projected to be robust, driven by its market penetration and the increasing adoption of P-CABs. Takeda has identified VOQUEZNA as a key growth driver within its pharmaceutical portfolio.

Takeda's financial guidance and statements consistently highlight VOQUEZNA's strong performance. The company has provided projections for continued sales growth. For instance, in its fiscal year 2023 results, Takeda indicated that VOQUEZNA sales exceeded expectations and are projected to continue this upward trend.

Factors influencing its financial trajectory:

• Market Penetration: Increasing physician awareness and prescribing habits for P-CABs, particularly for patients not adequately managed by PPIs or for H. pylori eradication.
• Geographic Expansion: Successful launches and market access in additional countries beyond the initial approvals.
• Indication Expansion: Potential for further approvals in related gastrointestinal disorders or improved treatment protocols.
• Patent Expiry: The primary patent expiration in 2030 is a significant milestone. While significant revenue is expected prior to this, generic entry will impact long-term sales post-exclusivity.
• Competition: The introduction of other P-CABs or novel therapies could moderate growth.

While specific forward-looking revenue projections are often proprietary and subject to change, industry analysts and Takeda's own reports suggest that VOQUEZNA is on track to become a blockbuster drug, with annual sales potentially exceeding $1 billion post-patent expiry through the creation of new formulations or indications, or by capturing a significant share of the existing market. However, the revenue trajectory leading up to patent expiry is expected to be characterized by strong double-digit growth.

What are the Key Takeaways?

• VOQUEZNA (vonoprazan) is approved for treating erosive esophagitis and H. pylori infection in adults.
• The primary U.S. patent for vonoprazan is scheduled to expire on November 10, 2030, with European and Japanese patents expiring around the same timeframe.
• VOQUEZNA has demonstrated significant sales growth, with net sales increasing from $67 million in FY2022 to $379 million in FY2023.
• The competitive landscape includes established PPIs and emerging P-CABs.
• VOQUEZNA is projected to become a significant revenue generator, with potential to exceed $1 billion annually, though this is dependent on market adoption and post-patent expiry strategies.

Frequently Asked Questions

1. What is the mechanism of action for VOQUEZNA? VOQUEZNA is a potassium-competitive acid blocker (P-CAB) that inhibits the gastric H+/K+-ATPase enzyme, thereby reducing gastric acid secretion.

2. Are there any known side effects of VOQUEZNA? Common side effects reported in clinical trials include diarrhea, constipation, nausea, abdominal pain, and bloating. The full safety profile is detailed in the prescribing information.

3. Can VOQUEZNA be used in pediatric patients? Currently, VOQUEZNA is approved for adult use only. Safety and efficacy in pediatric populations have not been established.

4. How does VOQUEZNA compare to proton pump inhibitors (PPIs)? VOQUEZNA offers faster and more sustained acid suppression compared to many PPIs, and it is not affected by CYP2C19 genetic polymorphism, which can influence PPI metabolism.

5. What are Takeda's plans for VOQUEZNA post-patent expiry? Takeda is likely to pursue strategies such as developing new formulations with extended release or combination therapies, seeking new indications, or potentially licensing agreements to mitigate the impact of generic competition after patent expiry.

Citations

[1] United States Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Database (Specific search for vonoprazan or Takeda may be required to pinpoint the exact listing)].