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Last Updated: February 16, 2025

Vadadustat - Generic Drug Details


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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 twenty-two patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for vadadustat
International Patents:222
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 29
Patent Applications: 117
What excipients (inactive ingredients) are in vadadustat?vadadustat excipients list
DailyMed Link:vadadustat at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vadadustat
Generic Entry 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

SponsorPhase
United States Department of DefensePhase 2
Akebia Therapeutics Inc.Phase 2
The University of Texas Health Science Center, HoustonPhase 2

See all vadadustat clinical trials

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 215192-002 Mar 27, 2024 RX Yes No 11,857,543 ⤷  Try for Free ⤷  Try for Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No 8,323,671 ⤷  Try for Free ⤷  Try for Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No 11,844,756 ⤷  Try for Free ⤷  Try for Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No 8,343,952 ⤷  Try for Free Y Y ⤷  Try for Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes RE47437 ⤷  Try for Free Y Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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/005131
Vafseo 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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for vadadustat

Country Patent Number Title Estimated Expiration
South Korea 20090060264 PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE ⤷  Try for Free
European Patent Office 3323807 INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE) ⤷  Try for Free
Turkey 201900548 ⤷  Try for Free
New Zealand 753904 Compositions and methods for treating anemia ⤷  Try for Free
Hong Kong 1248590 用於治療貧血的組合物和方法 (COMPOSITIONS AND METHODS FOR TREATING ANEMIA) ⤷  Try for Free
China 105916502 {[5-(3-氯苯基)-3-羟基吡啶-2-羰基]氨基}乙酸的固体形式,其组合物和用途 (Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof) ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for Vadadustat

Introduction to Vadadustat

Vadadustat, developed by Akebia Therapeutics, is an investigational new drug designed to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis. Here, we will delve into the market dynamics and financial trajectory of vadadustat, highlighting key milestones, financial performance, and future outlook.

Regulatory Approval and Market Authorization

FDA Approval

Vadadustat, now branded as Vafseo, has been a focal point for Akebia Therapeutics. After receiving a Complete Response Letter (CRL) from the FDA in the past, Akebia has made significant progress. As of March 2024, the FDA approved Vafseo for the treatment of anemia in patients with CKD on dialysis, marking a crucial milestone for the company[4].

European Approval

In addition to FDA approval, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of Vafseo in the European Union. This approval, if granted by the European Commission, would be applicable to all 27 EU member states plus Iceland, Norway, and Liechtenstein[3].

Financial Performance and Revenue Projections

Current Revenue Streams

Akebia's primary revenue source has been Auryxia (ferric citrate), a phosphate binder used in patients with CKD. In 2023, Auryxia generated net product revenues of $170.3 million, which has been instrumental in funding the company's operations and pipeline development[1].

Vadadustat Revenue Potential

With the approval of Vafseo, Akebia is poised to tap into a new revenue stream. The company has set the wholesale acquisition cost (WAC) for Vafseo at $1,278 for a 30-day supply, translating to approximately $15,500 per year. Sales in dialysis settings will include off-invoice discounts and volume-based tier discounts, which are expected to impact the net revenue but ensure competitive pricing[4].

Market Launch and Global Activities

Launch Strategy

Following FDA approval, Akebia's key priority has been to execute its launch strategy for Vafseo. This includes submitting the Transitional Drug Add-on Payment Adjustment (TDAPA) application, which is expected to result in HCPCS codes assignment by October 2024 and TDAPA designation by January 1, 2025. This will facilitate reimbursement and adoption in the U.S. healthcare system[4].

European Launch

Akebia has partnered with MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice) to launch Vafseo in Europe. The drug has already been launched in Germany, Austria, and the Netherlands, with further expansion planned[4].

Financial Trajectory and Funding

Cash Resources and Debt Financing

Akebia has strengthened its balance sheet through various financial maneuvers. The company secured a $55 million term loan financing with BlackRock and raised $26 million through an at-the-market (ATM) sales agreement. These funds are expected to support the company's operating plan for at least 24 months, especially if vadadustat is approved and launched successfully[1].

Cost Reduction Initiatives

In 2022, Akebia implemented several cost reduction initiatives, including restructuring and simplifying the Auryxia supply chain, which is anticipated to save significant cash over a five-year period. These measures have helped in creating a clear path to positive cash flows from operations supported by Auryxia revenues[3].

Pipeline Development and Future Outlook

New Pipeline Programs

Akebia has introduced new pipeline programs, including potential treatments for acute kidney injury, acute respiratory distress syndrome (AKB-9090), and retinopathy of prematurity in neonates (AKB-10108). These initiatives diversify the company's portfolio and offer potential future revenue streams[1].

Commercialization Partnerships

Akebia is seeking a partner to commercialize vadadustat in Europe, which could further enhance the drug's market reach and revenue potential. The company has also regained the rights for vadadustat from Otsuka Pharmaceutical Co. Ltd. in several key territories, including the U.S., Europe, and others[3].

Key Takeaways

  • Regulatory Approval: Vafseo (vadadustat) has received FDA approval and is pending European Commission approval.
  • Revenue Streams: Auryxia remains a significant revenue source, with Vafseo poised to contribute substantially post-launch.
  • Market Launch: Akebia is executing a comprehensive launch strategy in the U.S. and Europe.
  • Financial Stability: The company has secured additional funding through debt financing and ATM sales, ensuring a robust cash position.
  • Pipeline Development: New pipeline programs are under development, offering future growth opportunities.

FAQs

Q: What is the current status of vadadustat's regulatory approval? A: Vadadustat, now branded as Vafseo, has been approved by the FDA for the treatment of anemia in patients with CKD on dialysis. It is also awaiting final approval from the European Commission following a positive opinion from the CHMP[3][4].

Q: How does Akebia plan to launch Vafseo in the U.S.? A: Akebia has submitted the TDAPA application and plans to have HCPCS codes assigned by October 2024 and TDAPA designation by January 1, 2025. This will facilitate reimbursement and adoption in the U.S. healthcare system[4].

Q: What are the key financial highlights for Akebia Therapeutics in 2023? A: Akebia reported $170.3 million in net product revenues from Auryxia in 2023 and strengthened its balance sheet with a $55 million term loan financing and $26 million from ATM sales[1].

Q: What new pipeline programs is Akebia developing? A: Akebia has introduced new pipeline programs, including potential treatments for acute kidney injury, acute respiratory distress syndrome (AKB-9090), and retinopathy of prematurity in neonates (AKB-10108)[1].

Q: How does Akebia plan to commercialize vadadustat in Europe? A: Akebia is seeking a partner to commercialize vadadustat in Europe and has already launched Vafseo in several European countries through a partnership with MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice)[3][4].

Sources

  1. Akebia Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights. Akebia Therapeutics.
  2. Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights. Akebia Therapeutics.
  3. Akebia Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights. PR Newswire.
  4. Akebia Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights. Akebia Therapeutics.
  5. Akebia Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights. BioSpace.

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