VAFSEO Drug Patent Profile
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Which patents cover Vafseo, and when can generic versions of Vafseo launch?
Vafseo is a drug marketed by Akebia and is included in one NDA. There are two patents protecting this drug.
This drug has forty-seven patent family members in twenty-five countries.
The generic ingredient in VAFSEO is vadadustat. One supplier is listed for this compound. Additional details are available on the vadadustat profile page.
DrugPatentWatch® Generic Entry Outlook for Vafseo
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 14, 2027. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VAFSEO
| International Patents: | 47 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| What excipients (inactive ingredients) are in VAFSEO? | VAFSEO excipients list |
| DailyMed Link: | VAFSEO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VAFSEO
Generic Entry Date for VAFSEO*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Anatomical Therapeutic Chemical (ATC) Classes for VAFSEO
US Patents and Regulatory Information for VAFSEO
VAFSEO is protected by two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VAFSEO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VAFSEO
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Prolyl hydroxylase inhibitors and methods of use
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-002 | Mar 27, 2024 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-001 | Mar 27, 2024 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-002 | Mar 27, 2024 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 VAFSEO
| 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 VAFSEO
When does loss-of-exclusivity occur for VAFSEO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 07265460
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 85264
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0713350
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 59682
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1506149
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 70355
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 12021
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 44005
Estimated Expiration: ⤷ Try a Trial
Patent: 26044
Estimated Expiration: ⤷ Try a Trial
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 44005
Estimated Expiration: ⤷ Try a Trial
Patent: 27696
Estimated Expiration: ⤷ Try a Trial
Patent: 26044
Estimated Expiration: ⤷ Try a Trial
Patent: 23807
Estimated Expiration: ⤷ Try a Trial
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
Patent: 95127
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2007009992
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 29369
Estimated Expiration: ⤷ Try a Trial
Patent: 18548
Estimated Expiration: ⤷ Try a Trial
Patent: 58159
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 41300
Estimated Expiration: ⤷ Try a Trial
Patent: 59557
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6127
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 13838
Estimated Expiration: ⤷ Try a Trial
Patent: 09541486
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 09000286
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1730
Estimated Expiration: ⤷ Try a Trial
Patent: 1731
Estimated Expiration: ⤷ Try a Trial
Patent: 3002
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 44005
Estimated Expiration: ⤷ Try a Trial
Patent: 26044
Estimated Expiration: ⤷ Try a Trial
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 44005
Estimated Expiration: ⤷ Try a Trial
Patent: 26044
Estimated Expiration: ⤷ Try a Trial
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 29226
Estimated Expiration: ⤷ Try a Trial
Patent: 09102220
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 44005
Estimated Expiration: ⤷ Try a Trial
Patent: 57911
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1130592
Estimated Expiration: ⤷ Try a Trial
Patent: 090060264
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 54584
Estimated Expiration: ⤷ Try a Trial
Patent: 05587
Estimated Expiration: ⤷ Try a Trial
Patent: 22078
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1900548
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering VAFSEO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 3026044 | ⤷ Try a Trial | |
| Slovenia | 2044005 | ⤷ Try a Trial | |
| South Korea | 20090060264 | PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE | ⤷ Try a Trial |
| Slovenia | 3357911 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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