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
Sponsor | Phase |
---|---|
United States Department of Defense | Phase 2 |
Akebia Therapeutics Inc. | Phase 2 |
The University of Texas Health Science Center, Houston | Phase 2 |
Pharmacology 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
More… ↓
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