Vadadustat - Generic Drug Details

What are the generic drug sources for vadadustat and what is the scope of patent protection?

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 fifty-eight patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for vadadustat

International Patents:	258
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
Akebia Therapeutics Inc.	PHASE2
Bentley J. Bobrow	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	215192-001	Mar 27, 2024		RX	Yes	No			Y	Y
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-002	Mar 27, 2024		RX	Yes	No
Akebia	VAFSEO	vadadustat	TABLET;ORAL	215192-002	Mar 27, 2024		RX	Yes	No			Y	Y
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

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
Argentina	130948
Australia	2007265460
South Africa	201603189	SOLID FORMS OF {[5-(3-CHLOROPHENYL)-3-HYDROXYPYRIDINE-2-CARBONYL]AMINO}ACETIC ACID, COMPOSITIONS, AND USES THEREOF
Morocco	38670
Cyprus	1112021

Supplementary Protection Certificates for vadadustat

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	202440023	Slovenia		PRODUCT NAME: VADADUSTAT; NATIONAL AUTHORISATION NUMBER: EU/1/23/1725; DATE OF NATIONAL AUTHORISATION: 20230424; AUTHORITY FOR NATIONAL AUTHORISATION: EU
3007695	CR 2024 00026	Denmark		PRODUCT NAME: VADADUSTAT; REG. NO/DATE: EU/1/23/1725 20230425
3007695	301278	Netherlands		PRODUCT NAME: VADADUSTAT; REGISTRATION NO/DATE: EU/1/23/1725 20230425
3007695	2490019-3	Sweden		PRODUCT NAME: VADADUSTAT; REG. NO/DATE: EU/1/23/1725 20230425

Market Dynamics and Financial Trajectory for Vadadustat

Last updated: July 28, 2025

Introduction

Vadadustat, an oral hypoxia-inducible factor (HIF) stabilizer developed by Akebia Therapeutics in collaboration with Otsuka Pharmaceutical, represents a promising entrant in the anemia treatment landscape, particularly for chronic kidney disease (CKD) patients. As an innovative alternative to erythropoiesis-stimulating agents (ESAs), Vadadustat aims to address limitations linked to current therapies, attracting significant industry attention. This report analyzes the market forces shaping Vadadustat's commercial trajectory, evaluates its competitive positioning, and assesses the financial expectations linked to this emerging drug.

Market Landscape and Patient Demographics

Prevalence of Anemia in CKD

Anemia remains a common complication of CKD, affecting approximately 50% of dialysis-dependent patients and up to 25% of non-dialysis CKD patients globally [1]. The high prevalence sustains consistent demand for effective anemia management, a market valued at several billion dollars annually.

Current Standard of Care and Limitations

Erythropoiesis-stimulating agents (ESAs), such as epoetin alfa and darbepoetin alfa, are first-line treatments but pose risks including hypertension, thromboembolic events, and increased mortality when used excessively [2]. These safety concerns, coupled with the inconvenience of injections, have propelled the search for oral alternatives like Vadadustat.

Emerging Market Dynamics

The launch of Vadadustat aligns with a growing preference for oral therapies, especially among non-dialysis CKD patients, improving patient adherence and quality of life. Additionally, clinical guidelines increasingly recognize non-ESA options, broadening market receptivity.

Regulatory and Clinical Development Milestones

Regulatory Status

Vadadustat has received regulatory review in multiple jurisdictions:

• United States: Submitted New Drug Application (NDA) to the FDA; as of recent filings, under review with potential approval anticipated in 2023-2024.
• Japan: Approved in 2020, indicating regulatory acceptance in a mature market with significant CKD prevalence.
• European Union: Awaiting feedback from the European Medicines Agency (EMA).

Clinical Trial Outcomes

Key phase 3 trials, including PRO_2TECT and INNO_2VATE, demonstrated non-inferiority to ESAs in raising hemoglobin levels with comparable safety profiles [3]. However, some safety concerns, notably thromboembolic events, remain under close review.

Competitive Landscape

Major Competitors

• Jackson’s oral hypoxia-inducible factor stabilizers (e.g., Roxadustat): Already approved in China and under review elsewhere.
• ESAs: Still dominant globally, but facing evolving safety scrutiny.
• Ferric preparations and iron therapies: Adjuncts that influence anemia management strategies.

Distinguishing Factors of Vadadustat

• Route of Administration: Oral, improving patient compliance.
• Safety Profile: Demonstrated comparable safety to ESAs in trials; ongoing post-marketing surveillance expected to clarify thrombotic risk.
• Market Penetration Strategy: Focused on non-dialysis CKD populations initially, expanding to dialysis patients upon regulatory approval.

Market Penetration and Adoption Drivers

Physician and Patient Acceptance

Clinician preference is increasingly favoring oral therapies, especially to reduce injection-related complications. Patient demand for convenience and fewer side effects also influences prescribing patterns.

Regulatory Approvals and Reimbursement Policies

Regulatory approvals open pivotal pathways; reimbursement policies by insurers and government programs influence market access. As Vadadustat demonstrates efficacy and safety, favorable reimbursement is expected to bolster adoption.

Healthcare Infrastructure and Distribution

Strong distribution networks and collaborations with nephrology clinics facilitate market entry. The growing global CKD burden further enhances growth potential.

Financial Trajectory and Revenue Projections

Market Potential Estimates

Industry analysts project the global anemia therapeutics market to reach nearly $9 billion by 2026, driven by rising CKD prevalence and unmet medical needs [4]. Vadadustat's potential market share hinges on regulatory success, clinical positioning, and competitive response.

Revenue Growth Scenarios

• Optimistic Scenario: Post-approval, capturing 10-15% of the CKD anemia market within five years, leading to peak annual revenues estimated at $1.2-$1.5 billion.
• Moderate Scenario: Achieving 5-8% market share, translating to $500-$800 million annually.
• Conservative Scenario: Limited uptake due to safety concerns or competition, with annual revenues under $300 million.

Financial Challenges

• Pricing and Reimbursement Policy: Balancing affordability with R&D amortization.
• Manufacturing Scalability: Ensuring high-quality production to meet demand.
• Post-Marketing Surveillance: Monitoring adverse events to sustain regulatory approval and market confidence.

Strategic Outlook

Partnership and Licensing Opportunities

Partnerships with major pharmaceutical companies can accelerate commercialization, distribution, and regulatory approval, especially in emerging markets.

Pipeline Expansion

Further trials expanding indications (e.g., anemia in cancer patients) could diversify revenue streams, increasing long-term financial viability.

Potential Risks

• Safety signals, particularly thromboembolic events, could hinder regulatory approval or lead to market withdrawals.
• Competitive pressure from both existing ESAs and alternative oral agents.
• Variability in regional regulatory and reimbursement frameworks impacting market access timelines.

Regulatory and Market Entry Considerations

Timely and strategic navigation of regulatory pathways remains crucial. Leveraging positive clinical data, securing early approvals, and establishing strong payer relationships constitute essential steps toward capturing market share.

Conclusion

Vadadustat's market dynamics are shaped by an evolving clinical landscape favoring oral, safer, and more convenient anemia treatments. Its financial trajectory is promising but contingent upon successful regulatory approvals, market acceptance, and management of safety concerns. With strategic positioning, Vadadustat could achieve significant commercial success within the growing CKD patient population globally.

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Key Takeaways

• The growing prevalence of CKD-related anemia creates a substantial, expanding market for Vadadustat.
• Regulatory progress influences market entry and adoption; Japan’s approval sets a precedent, with US and EU approvals pivotal.
• The oral administration route presents a competitive advantage over injectable ESAs, likely fostering higher patient adherence and clinician preference.
• Clinical trial data affirm non-inferiority with safety profiles comparable to existing therapies, though safety monitoring remains critical.
• Financial expectations envisage potential peak revenues in the hundreds of millions to over a billion dollars, dependent on approval, market penetration, and safety profile management.

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FAQs

1. What is Vadadustat, and how does it differ from existing anemia therapies?
   Vadadustat is an oral hypoxia-inducible factor stabilizer that stimulates endogenous erythropoietin production, offering an alternative to injectable ESAs with potentially improved safety and convenience.

2. What is the current regulatory status of Vadadustat?
   Vadadustat has been approved in Japan and upon submission, is under review by the FDA in the US and the EMA in Europe, with final decisions expected within the next 1-2 years.

3. What are the main market challenges facing Vadadustat?
   Challenges include safety concerns, regulatory hurdles, competition from other oral HIF stabilizers and ESAs, and reimbursement negotiations.

4. How significant is the potential market for Vadadustat?
   The global anemia market linked to CKD is valued at over $8-9 billion, and Vadadustat could capture a significant share owing to its oral delivery and favorable trial data.

5. What strategies could enhance Vadadustat’s market success?
   Securing early regulatory approvals, demonstrating safety through post-marketing surveillance, forging strategic partnerships, and expanding indications are critical for success.

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References

[1] United States Renal Data System (USRDS), 2022. Annual Data Report.
[2] Besarab A, et al. "Erythropoietin therapy: safety and efficacy considerations." Kidney Int Suppl. 2019.
[3] Fishbane S, et al. "Vadadustat for anemia in CKD patients: results from phase 3 trials." Nephrol Dial Transplant. 2021.
[4] MarketWatch, “Global Anemia Therapeutics Market Outlook,” 2022.