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Last Updated: October 31, 2024

Vadadustat - Generic Drug Details


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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 eighteen patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for vadadustat
International Patents:218
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 215192-001 Mar 27, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-002 Mar 27, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-001 Mar 27, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-003 Mar 27, 2024 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Akebia VAFSEO vadadustat TABLET;ORAL 215192-002 Mar 27, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Mexico 2022003510 COMPOSICIONES Y METODOS PARA TRATAR ANEMIA. (COMPOSITIONS AND METHODS FOR TREATING ANEMIA.) ⤷  Sign Up
Taiwan 201534302 Compositions and methods for treating anemia ⤷  Sign Up
Brazil 112016011065 composto cristalino, composição farmacêutica, forma de dosagem, método para tratar anemia ⤷  Sign Up
Taiwan I665190 ⤷  Sign Up
Australia 2016243700 Compositions and methods for treating anemia ⤷  Sign Up
Israel 281058 הרכבים ושיטות לטיפול באנמיה (Compositions and methods for treating anemia) ⤷  Sign Up
Philippines 12015502738 COMPOSITIONS AND METHODS FOR TREATING ANEMIA ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.