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 sixteen patent family members in forty-three countries.
One supplier is listed for this compound.
Summary for vadadustat
| International Patents: | 216 |
| US Patents: | 13 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 29 |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for vadadustat
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 | ⤷ Sign Up | ||||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-003 | Mar 27, 2024 | RX | Yes | Yes | ⤷ 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 | ||
| >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 |
|---|---|---|---|
| Taiwan | 202320770 | Compositions and methods for treating anemia | ⤷ Sign Up |
| Hong Kong | 1248590 | 用於治療貧血的組合物和方法 (COMPOSITIONS AND METHODS FOR TREATING ANEMIA) | ⤷ Sign Up |
| South Africa | 201905255 | SOLID FORMS OF {[5-(3-CHLOROPHENYL)-3-HYDROXYPYRIDINE-2-CARBONYL]AMINO}ACETIC ACID, COMPOSITIONS, AND USES THEREOF | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
