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 thirteen patents protecting this drug.
This drug has two hundred and eighteen patent family members in forty-three 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
Vafseo will be eligible for patent challenges on March 27, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be March 27, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for VAFSEO
| International Patents: | 218 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Applications: | 65 |
| 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:
NEW CHEMICAL ENTITY 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.
US Patents and Regulatory Information for VAFSEO
VAFSEO is protected by thirteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VAFSEO is ⤷ Subscribe.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
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
Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Patent Number: 10,149,842
Patent Expiration: ⤷ Subscribe
Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Patent Number: 11,065,237
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Patent Number: 11,324,734
Patent Expiration: ⤷ Subscribe
Patent Number: 11,844,756
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Patent Number: 11,857,543
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Patent Number: 7,811,595
Patent Expiration: ⤷ Subscribe
Prolyl hydroxylase inhibitors and methods of use
Patent Number: 8,323,671
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Prolyl hydroxylase inhibitors and methods of use
Patent Number: 8,343,952
Patent Expiration: ⤷ Subscribe
Prolyl hydroxylase inhibitors and methods of use
Patent Number: 8,598,210
Patent Expiration: ⤷ Subscribe
Prolyl hydroxylase inhibitors and methods of use
Patent Number: 8,940,773
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Patent Number: 9,701,636
Patent Expiration: ⤷ Subscribe
Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
Patent Number: 9,987,262
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE IN ADULTS WHO HAVE BEEN RECEIVING DIALYSIS FOR AT LEAST THREE MONTHS
Patent Number: RE47437
Patent Expiration: ⤷ Subscribe
FDA Regulatory Exclusivity protecting VAFSEO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe
| 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 | 215192-003 | Mar 27, 2024 | RX | Yes | Yes | 8,598,210 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-003 | Mar 27, 2024 | RX | Yes | Yes | 9,987,262 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-002 | Mar 27, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-003 | Mar 27, 2024 | RX | Yes | Yes | 8,940,773 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-003 | Mar 27, 2024 | RX | Yes | Yes | 11,857,543 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Akebia | VAFSEO | vadadustat | TABLET;ORAL | 215192-001 | Mar 27, 2024 | RX | Yes | No | 11,857,543 | ⤷ Subscribe | ⤷ Subscribe | ||||
| >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
Patent: Prolyl hydroxylase inhibitors and methods of use
Estimated Expiration: ⤷ Subscribe
Austria
Patent: 85264
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 0713350
Patent: inibidores de prolil hidroxilase e métodos de utilização
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 59682
Patent: INHIBITEURS DE LA PROLYL HYDROXYLASE ET PROCEDES D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
China
Patent: 1506149
Patent: Prolyl hydroxylase inhibitors and methods of use
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 70355
Patent: INHIBIDORES PROLIL HIDROXILASA Y METODOS DE USO
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 12021
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 44005
Estimated Expiration: ⤷ Subscribe
Patent: 26044
Estimated Expiration: ⤷ Subscribe
Patent: 57911
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 44005
Patent: INHIBITEURS DE LA PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Patent: 27696
Patent: Inhibiteurs de la prolyl hydroxylase et procédés d'utilisation (Prolyl hydroxylase inhibitors and methods of use)
Estimated Expiration: ⤷ Subscribe
Patent: 26044
Patent: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Patent: 23807
Patent: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Patent: 57911
Patent: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Patent: 95127
Patent: INHIBITEURS DE PROLYL HYDROXYLASE ET PROCÉDÉS D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Germany
Patent: 2007009992
Estimated Expiration: ⤷ Subscribe
Hong Kong
Patent: 29369
Patent: PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE
Estimated Expiration: ⤷ Subscribe
Patent: 18548
Patent: 脯氨醯羥化酶抑制劑及其使用方法 (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Patent: 58159
Patent: 脯氨醯羥化酶抑制劑及使用方法 (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE)
Estimated Expiration: ⤷ Subscribe
Hungary
Patent: 41300
Estimated Expiration: ⤷ Subscribe
Patent: 59557
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 6127
Patent: מעכבי פרוליל הידרוקסילאז, מלחים שלהם המקובלים ברוקחות, תכשירי רוקחות המכילים אותם, ושימושים שלהם לטיפול במגוון מחלות (Prolyl hydroxylase inhibitors, pharmaceutically acceptable salts thereof, pharmaceutical compositions containing them and uses thereof for the treatment of a variety of diseases)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 13838
Estimated Expiration: ⤷ Subscribe
Patent: 09541486
Estimated Expiration: ⤷ Subscribe
Lithuania
Patent: 57911
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 09000286
Patent: INHIBIDORES DE PROLIL HIDROXILASA Y METODOS DE USO. (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE.)
Estimated Expiration: ⤷ Subscribe
New Zealand
Patent: 1730
Patent: Prolyl hydroxylase inhibitors and methods of use
Estimated Expiration: ⤷ Subscribe
Patent: 1731
Patent: Prolyl hydroxylase inhibitors and methods for use
Estimated Expiration: ⤷ Subscribe
Patent: 3002
Patent: Prolyl hydroxylase inhibitors and methods of use
Estimated Expiration: ⤷ Subscribe
Poland
Patent: 44005
Estimated Expiration: ⤷ Subscribe
Patent: 26044
Estimated Expiration: ⤷ Subscribe
Patent: 57911
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 44005
Estimated Expiration: ⤷ Subscribe
Patent: 26044
Estimated Expiration: ⤷ Subscribe
Patent: 57911
Estimated Expiration: ⤷ Subscribe
Russian Federation
Patent: 29226
Patent: ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ (PROLYL HYDROXYLASE INHIBITORS AND APPLICATION METHODS THEREOF)
Estimated Expiration: ⤷ Subscribe
Patent: 09102220
Patent: ИНГИБИТОРЫ ПРОЛИЛГИДРОКСИЛАЗЫ И СПОСОБЫ ИХ ПРИМЕНЕНИЯ
Estimated Expiration: ⤷ Subscribe
Slovenia
Patent: 44005
Estimated Expiration: ⤷ Subscribe
Patent: 57911
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1130592
Estimated Expiration: ⤷ Subscribe
Patent: 090060264
Patent: PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 54584
Estimated Expiration: ⤷ Subscribe
Patent: 05587
Estimated Expiration: ⤷ Subscribe
Patent: 22078
Estimated Expiration: ⤷ Subscribe
Turkey
Patent: 1900548
Estimated Expiration: ⤷ Subscribe
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 |
|---|---|---|---|
| Canada | 2659682 | INHIBITEURS DE LA PROLYL HYDROXYLASE ET PROCEDES D'UTILISATION (PROLYL HYDROXYLASE INHIBITORS AND METHODS OF USE) | ⤷ Subscribe |
| Denmark | 3277270 | ⤷ Subscribe | |
| Israel | 281058 | הרכבים ושיטות לטיפול באנמיה (Compositions and methods for treating anemia) | ⤷ Subscribe |
| Poland | 3277270 | ⤷ Subscribe | |
| Australia | 2022259767 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof | ⤷ Subscribe |
| Australia | 2020294308 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof | ⤷ Subscribe |
| >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.
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