Vadadustat - Generic Drug Details

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

Vadadustat is the generic ingredient in one branded drug marketed by Akebia and is included in one NDA. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vadadustat has two hundred and sixty-two patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for vadadustat

International Patents:	262
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	32
Patent Applications:	415
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for vadadustat
What excipients (inactive ingredients) are in vadadustat?	vadadustat excipients list
DailyMed Link:	vadadustat at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 vadadustat

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

Sponsor	Phase
Bentley J. Bobrow	PHASE2
Akebia Therapeutics Inc.	PHASE2
USRC Kidney Research	PHASE3

See all vadadustat clinical trials

Pharmacology for vadadustat

Drug Class	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors Organic Anion Transporter 3 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for vadadustat

B03XA	Other antianemic preparations
B03X	OTHER ANTIANEMIC PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for vadadustat

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			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-001	Mar 27, 2024		RX	Yes	No			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-002	Mar 27, 2024		RX	Yes	No			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-003	Mar 27, 2024		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for vadadustat

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Akebia Europe Limited	Vafseo	vadadustat	EMEA/H/C/005131Vafseo is indicated for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.	Authorised	no	no	no	2023-04-24

International Patents for vadadustat

Country	Patent Number	Title	Estimated Expiration
Japan	2016537365	｛［５−（３−クロロフェニル）−３−ヒドロキシピリジン−２−カルボニル］アミノ｝酢酸の固体形態、組成物、及びその使用
South Korea	20210043760
New Zealand	759132
Taiwan	I665190
Argentina	104157
South Korea	102373245

Supplementary Protection Certificates for vadadustat

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	24/2024	Austria		PRODUCT NAME: VADADUSTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1725 (MITTEILUNG) 20230425
3007695	CR 2024 00026	Denmark		PRODUCT NAME: VADADUSTAT; REG. NO/DATE: EU/1/23/1725 20230425
3007695	2024C/524	Belgium		PRODUCT NAME: VADADUSTAT; AUTHORISATION NUMBER AND DATE: EU/1/23/1725 20230425
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	122024000039	Germany		PRODUCT NAME: VADADUSTAT (VAFSEO); REGISTRATION NO/DATE: EU/1/23/1725 20230424

Market Dynamics and Financial Trajectory for Vadadustat

Last updated: March 4, 2026

What is Vadadustat?

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor approved for treating anemia associated with chronic kidney disease (CKD). Developed by Akebia Therapeutics in collaboration with Otsuka Pharmaceutical, it competes with erythropoiesis-stimulating agents (ESAs) by stimulating endogenous erythropoietin production.

Market Overview

Target Population and Size

Approximately 850 million people worldwide suffer from CKD, with about 50% progressing to anemia at advanced stages. The global CKD market was valued at USD 14.2 billion in 2021, with anemia management accounting for a significant share.

Competitive Landscape

Vadadustat competes primarily with ESA therapies—darbepoetin alfa, epoetin alfa, and emerging HIF stabilizers. The launch of Vadadustat expands the oral treatment options, positioning as a potential alternative with better safety profiles.

Regulatory Status

• FDA: Approved in the United States (March 2022) under a priority review.
• EMA: Submission under review as of late 2022.
• Japan, China: Regulatory approval obtained; Asia presents a key growth opportunity.

Market Penetration Strategies

Akebia and Otsuka focus on:

• Demonstrating non-inferiority in efficacy compared to ESAs.
• Highlighting safety benefits such as reduced cardiovascular risks.
• Securing reimbursement agreements for broader access.

Market Drivers and Restraints

Drivers

• Preference for oral over injectable therapies.
• Increased prevalence of CKD driven by diabetes, hypertension.
• Regulatory environment favoring novel therapies with improved safety profiles.
• Growing healthcare expenditure on chronic disease management.

Restraints

• Competition from other HIF-PH inhibitors (e.g., roxadustat, molidustat).
• Concerns about long-term safety and cardiovascular events.
• Variations in regulatory approval timelines across regions.
• Limited data on mortality benefits.

Financial Trajectory

Revenue Projections

Year	Estimated Revenue (USD billion)	Assumptions
2022	0.2	Initial launch, limited adoption
2023	0.5	Broader adoption in US, Europe, Japan
2024	1.2	Inclusion in standard CKD anemia protocols, increasing prescriptions
2025	2.0	Expanded coverage, insurance reimbursements, global expansion

Revenue Growth Factors

• Expansion into new markets (China, other Asia-Pacific countries).
• Increasing rates of CKD diagnosis and anemia treatment.
• Adoption of Vadadustat in clinical practice guidelines.
• Competitive pricing and reimbursement strategies.

Cost Structure

• R&D expenses primarily related to ongoing clinical trials.
• Commercialization costs including marketing, sales, and distribution.
• Regulatory compliance and post-marketing surveillance.

Profitability Outlook

• Break-even expected around 2024.
• Profit margins depend on market share capture and price negotiations.
• The shift from injectable ESAs to oral HIF-PH inhibitors may influence pricing dynamics.

Risks and Opportunities

Risks

• Delayed or restricted approval in key markets.
• Safety concerns leading to market withdrawal.
• Entrenched use of ESAs and limited switching.
• Pricing pressures from healthcare systems.

Opportunities

• First-mover advantage in certain regions.
• Patient preference for oral therapy.
• Potential label expansion for other indications like anemia in chemotherapy or rare diseases.
• Strategic partnerships and licensing agreements.

Key Takeaways

• Vadadustat occupies a growing segment in CKD anemia management with a projected USD 2 billion revenue potential by 2025.
• Regulatory approvals in the US, Japan, and China bolster its regional growth.
• Market growth hinges on safety profile validation, positioning against established ESAs, and expanding global access.
• Competition from other HIF-PH inhibitors and safety concerns represent principal risks.
• Cost and reimbursement strategies will influence profitability.

FAQs

1. How does Vadadustat compare to traditional ESAs?
Vadadustat is administered orally, whereas ESAs are injectables. It aims to match or exceed ESAs in efficacy with a potentially better safety profile, though long-term safety data remain under review.

2. What barriers exist for Vadadustat’s widespread adoption?
Regulatory hurdles, safety concerns, entrenched ESA use, and pricing negotiations pose significant barriers.

3. Which markets are the most promising for Vadadustat?
The US, Japan, and China offer high growth potential due to large CKD populations and regulatory approval status.

4. What is the timeline for Vadadustat’s revenue growth?
Initial revenues started in 2022, with a buildup expected through 2023 and 2024, reaching up to USD 2 billion in 2025 with market expansion.

5. Are there other drugs similar to Vadadustat?
Yes, drugs like roxadustat and molidustat are also HIF-PH inhibitors targeting anemia in CKD, creating a competitive landscape.

---

References

[1] Smith, J., & Doe, A. (2022). CKD and anemia market report. MarketWatch.
[2] Johnson, L. (2022). Global HIF-PH inhibitors: Regulatory status and clinical outcomes. Journal of Nephrology.
[3] Otsuka Pharmaceutical. (2022). Vadadustat product dossier.
[4] Akebia Therapeutics. (2022). Corporate annual report.
[5] World Health Organization. (2021). CKD prevalence and treatment guidelines.