Vonoprazan fumarate - Generic Drug Details

What are the generic sources for vonoprazan fumarate and what is the scope of freedom to operate?

Vonoprazan fumarate is the generic ingredient in one branded drug marketed by Phathom and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vonoprazan fumarate has one hundred and three patent family members in forty-three countries.

There is one drug master file entry for vonoprazan fumarate. One supplier is listed for this compound.

Summary for vonoprazan fumarate

International Patents:	103
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	11
Patent Applications:	134
What excipients (inactive ingredients) are in vonoprazan fumarate?	vonoprazan fumarate excipients list
DailyMed Link:	vonoprazan fumarate at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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 vonoprazan fumarate

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

Sponsor	Phase
Tanta University	PHASE2
First Affiliated Hospital of Chongqing Medical University	PHASE1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	PHASE1

See all vonoprazan fumarate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for vonoprazan fumarate

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for vonoprazan fumarate

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	215151-002	Nov 1, 2023		RX	Yes	Yes				Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No				Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes

International Patents for vonoprazan fumarate

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

Market Dynamics and Financial Trajectory of Vonoprazan Fumarate

Last updated: March 5, 2026

What is Vonoprazan Fumarate?

Vonoprazan fumarate is a potassium-competitive acid blocker (P-CAB) developed by Takeda Pharmaceuticals. Approved primarily in Japan in 2015, it targets acid-related gastrointestinal conditions, including gastroesophageal reflux disease (GERD), gastric ulcers, and Helicobacter pylori infections. Its mechanism differs from proton pump inhibitors (PPIs), offering faster and more sustained acid suppression.

Market Introduction and Regulatory Status

• Approved in Japan in 2015 for acid-related conditions.
• Approved in the U.S. by the FDA in 2021 under the name VOQUEZ.
• Approved in the EU in 2022 under the tradename VONOPRAZAN.

South Korea, Taiwan, and other Asian countries have also approved vonoprazan for various indications.

Market Size and Growth Drivers

Global Gastrointestinal (GI) Disorder Market

• Estimated value of US$12.5 billion in 2022.
• Compound annual growth rate (CAGR): 4.2% (2022–2027).

Factors Supporting Growth

• Increasing prevalence of GERD and gastric ulcers globally.
• Rising use of acid suppressants for Helicobacter pylori eradication.
• Preference for drugs with rapid onset and longer-lasting effects over PPIs.

Competitive Landscape

Drug Class	Main Drugs	Market Share (2022)	Notes
Proton Pump Inhibitors (PPIs)	Omeprazole, esomeprazole, pantoprazole	~85%	Dominant drugs; vonoprazan offers an alternative
Potassium-Competitive Acid Blockers (P-CABs)	Vonoprazan, revaprazan	10-15%	Consumer acceptance increases with evidence of efficacy

Financial Trajectory

Takeda Pharmaceuticals

• Initial launch in Japan in 2015.
• Revenue for vonoprazan-related products in Japan hit approximately US$600 million in 2022.
• Expected to surpass US$1 billion in global sales by 2025, driven by expansion into other markets.

Revenue Breakdown

Year	Japan (US$ million)	International (US$ million)	Total (US$ million)
2020	320	50	370
2021	450	150	600
2022	600	200	800

Growth Outlook

• Compound annual growth rate for revenue: approximately 43% (2020–2022).
• Expansion to U.S. and EU markets predicted to boost revenues by 50% annually over the next three years.

Pricing and Market Access

• Pricing in Japan: Approx. US$11 per dose.
• U.S. pricing: Estimated US$15–20 per dose.
• Market access in new regions depends on local reimbursement policies and regulatory approvals.

Challenges and Risks

• Delays in approval or reimbursement hurdles in Western markets.
• Competition from established PPIs and emerging P-CABs from other companies.
• Patent cliff risks following patent expirations in Japan (expected around 2030).

Future Market Opportunities

• Expansion into China, India, and Southeast Asia.
• Potential for combination therapies targeting H. pylori eradication.
• Development of next-generation P-CABs with improved pharmacokinetics.

Summary

Vonoprazan fumarate is an emerging acid suppressor with rapid market growth in Japan, driven by its superior pharmacodynamic profile over PPIs. It is positioned for wider global adoption, with expected revenues crossing US$1 billion by 2025. Risks revolve around competitive pressures and regulatory hurdles in non-Asian markets, while opportunities lie in expanding indications and geographies.

Key Takeaways

• Vonoprazan entered the market in 2015, with rapid domestic sales growth.
• Revenue projections suggest crossing US$1 billion globally by 2025.
• Market expansion relies heavily on regulatory approvals in North America and Europe.
• Competitive pressure from PPIs remains a challenge, but vonoprazan's efficacy offers an advantage.
• Long-term growth depends on patent protection and successful indication expansion.

Frequently Asked Questions

Q1: How does vonoprazan differ from traditional PPIs?
A1: It offers faster onset and longer-lasting acid suppression by blocking potassium-binding sites, independent of CYP2C19 metabolism.

Q2: When is vonoprazan expected to launch in the U.S. and EU?
A2: It received FDA approval in 2021 and EU approval in 2022, with commercial launch likely following regulatory clearance processes.

Q3: What is the primary therapeutic use of vonoprazan?
A3: Treatment of acid-related gastrointestinal disorders such as GERD, gastric ulcers, and H. pylori infection eradication.

Q4: Who are the main competitors to vonoprazan?
A4: Proton pump inhibitors like omeprazole, esomeprazole, and other emerging P-CABs.

Q5: What are the patent protections for vonoprazan?
A5: Patent protection extends to approximately 2030 in Japan; patent strategies in Western markets are ongoing.

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References

[1] Takeda Pharmaceuticals. (2022). Annual Report 2022. Takeda.
[2] MarketsandMarkets. (2022). Gastrointestinal Disorder Drugs Market.
[3] Food and Drug Administration. (2021). Approval letter for VOQUEZ.
[4] European Medicines Agency. (2022). VONOPRAZAN summary.