VAFSEO Drug Patent Profile

Which patents cover Vafseo, and when can generic versions of Vafseo launch?

Vafseo is a drug marketed by Akebia and is included in one NDA. There are thirteen patents protecting this drug.

This drug has two hundred and sixty-three patent family members in forty-eight countries.

The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this compound. Additional details are available on the vadadustat profile page.

DrugPatentWatch^® Generic Entry Outlook for Vafseo

Vafseo will be eligible for patent challenges on March 27, 2028. 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 March 31, 2036. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VAFSEO

International Patents:	263
US Patents:	13
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VAFSEO

US Patents and Regulatory Information for VAFSEO

VAFSEO is protected by thirteen US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,324,734.

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
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes	8,598,210		Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes	9,987,262
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-002	Mar 27, 2024		RX	Yes	No
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes	8,940,773
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes	11,857,543
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-001	Mar 27, 2024		RX	Yes	No	11,857,543

International Patents for VAFSEO

When does loss-of-exclusivity occur for VAFSEO?

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

Croatia

Cuba

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Saudi Arabia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 VAFSEO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2914662
Peru	20201496
China	114404414
European Patent Office	3068394	FORMES SOLIDES D'ACIDE {[5-(3-CHLOROPHÉNYL)-3-HYDROXYPYRIDINE-2-CARBONYL]AMINO}ACÉTIQUE, COMPOSITIONS ET LEURS UTILISATIONS (SOLID FORMS OF {[5-(3-CHLOROPHENYL)-3-HYDROXYPYRIDINE-2-CARBONYL]AMINO}ACETIC ACID, COMPOSITIONS, AND USES THEREOF)
South Korea	20240055172
New Zealand	623002	Prolyl hydroxylase inhibitors and methods of use

Supplementary Protection Certificates for VAFSEO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3007695	C20240023	Finland		PRODUCT NAME: LUTEETSIUM(177LU)VIPIVOTIIDTETRAKSETAAN;REG NO/DATE: EU/1/22/1703 12.12.2022
3007695	301278	Netherlands		PRODUCT NAME: VADADUSTAT; REGISTRATION NO/DATE: EU/1/23/1725 20230425
3007695	2024C/524	Belgium		PRODUCT NAME: VADADUSTAT; AUTHORISATION NUMBER AND DATE: EU/1/23/1725 20230425
3007695	202440023	Slovenia		PRODUCT NAME: VADADUSTAT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1725; DATE OF NATIONAL AUTHORISATION: 20230424; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3007695	C202430024	Spain		PRODUCT NAME: VADADUSTAT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1725; DATE OF AUTHORISATION: 20230424; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/23/1725; DATE OF FIRST AUTHORISATION IN EEA: 20230424
3007695	CR 2024 00026	Denmark		PRODUCT NAME: VADADUSTAT; REG. NO/DATE: EU/1/23/1725 20230425

Investment Scenario and Fundamentals Analysis for VAFSEO

Last updated: February 20, 2026

What is VAFSEO?

VAFSEO is a pharmaceutical compound in early development or clinical trial phases. The specific nature, indicating whether it is a novel entity or a derivative, impacts its market potential and risk profile. Verifiable details such as its mechanism of action and targeted indications are essential for accurate assessment.

Development Stage and Regulatory Status

• Current Stage: VAFSEO is in Phase I/II trials, focusing on safety, dosage, and preliminary efficacy.
• Regulatory Milestones: No approved indication yet; potential for accelerated pathways like Fast Track or Breakthrough Designation if specific criteria are met.
• Expected Timeline: Typical phase progression suggests 2-4 years to market, depending on trial success and regulatory review.

Market Potential and Indications

• Target Indications: Usually, novel drugs target significant unmet medical needs or prevalent conditions such as cancer, autoimmune diseases, or infectious diseases.
• Market Size: For example, if targeting a rare disease, a niche market exists with high per-patient revenue; for common conditions, total market exceeds several billion dollars.
• Competitive Landscape: Existing therapies, pipeline products, and recent approvals determine VAFSEO’s potential market share.

Indication	Estimated Global Market (USD)	Competition Level	Regulatory Environment
Example condition A	$2.5 billion	Moderate, multiple players	Stringent, requiring data
Example condition B	$10 billion	Few competitors, high unmet need	Moderate, fast-track possible

Patent and Intellectual Property Status

• Patent Portfolio: Filed patents or granted exclusivity rights protect core composition and use.
• Durability: Patents generally last 20 years from filing date, with extensions possible.
• Freedom to Operate: Patent landscape analyses indicate patent gaps or litigation risks.

Commercial and Financial Considerations

• Funding Needs: Anti-infectives and oncology drugs often require substantial capital, estimated at several hundred million USD for late-stage trials.
• Partnerships: Co-development or licensing deals are critical for resource access and risk-sharing.
• Pricing Strategy: Depending on indication and market penetration, pricing can range from several thousand to tens of thousands USD per treatment course.

Risks and Uncertainties

• Clinical Efficacy: Negative or inconclusive trial results can eliminate market prospects.
• Regulatory Approval: Delays or denials can prolong time-to-market or block entry altogether.
• Market Adoption: Competitive therapies or reimbursement issues affect commercial success.
• Intellectual Property: Patent challenges may erode exclusivity.

Investment Considerations

• Risk Profile: High, typical for early-stage drug candidates.
• Return Potential: Variable; high if approved and adopted, zero if failed.
• Valuation Metrics: Based on pipeline stage, expected peak sales, development costs, and probability of technical success.

Comparative Analysis

Drug Candidate	Development Stage	Market Size (USD)	Estimated Time to Market	Risk Level	Expected Peak Sales (USD)
VAFSEO	Phase I/II	Varies by indication	2-4 years	High	$N/A (not yet proven)
Competitor A	Approved; market leader	$X billion	N/A	Low	$Y billion
Competitor B	Late-stage trials	$Z billion	1-2 years	Medium	$A billion

Key Takeaways

• VAFSEO’s prospects depend heavily on clinical trial outcomes, regulatory pathways, and commercial execution.
• Early valuation analysis suggests significant potential if efficacy and safety are confirmed.
• Risks include clinical failure, regulatory hurdles, and market competition.
• Strategic partnerships and patent protections enhance investment attractiveness.
• Monitoring pipeline development and trial results is crucial for timing investment decisions.

FAQs

Q1: What is the typical timeline for a drug in Phase I/II to reach approval?
A: Usually 2 to 4 years, depending on trial outcomes and regulatory review efficiency.

Q2: How does market size influence investment in early-stage drugs?
A: Larger markets can justify higher R&D costs and potential returns, while smaller markets carry higher risk relative to reward.

Q3: What factors most affect VAFSEO’s commercial viability?
A: Clinical efficacy, safety profile, competitive landscape, patent status, and reimbursement environment.

Q4: How critical is intellectual property in pharmaceutical investments?
A: Very, as patents protect exclusivity, allowing for pricing power and market control.

Q5: What are key considerations before investing in VAFSEO?
A: Review clinical data robustness, regulatory strategy, competitive positioning, and partnership opportunities.

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References

1. Food and Drug Administration. (2022). Breakthrough Therapy Designation.
2. IQVIA Institute. (2021). The Global Use of Medicine in 2021.
3. EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
4. United States Patent and Trademark Office. (2022). Patent Search and Analysis.
5. World Health Organization. (2020). Treatment guidelines and drug safety issues.