Vafseo is a drug owned by Akebia Therapeutics Inc. It is protected by 13 US drug patents filed in 2024 out of which none have expired yet. Vafseo's patents will be open to challenges from 27 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 31, 2036. Details of Vafseo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US9701636 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof |
Nov, 2034
(9 years from now) | Active |
| US10149842 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof |
Nov, 2034
(9 years from now) | Active |
| US11065237 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof |
Nov, 2034
(9 years from now) | Active |
| US7811595 | Prolyl hydroxylase inhibitors and methods of use |
Mar, 2028
(3 years from now) | Active |
| US8343952 | Prolyl hydroxylase inhibitors and methods of use |
Aug, 2027
(2 years from now) | Active |
| US8598210 | Prolyl hydroxylase inhibitors and methods of use |
Jun, 2027
(2 years from now) | Active |
| USRE47437 | Prolyl hydroxylase inhibitors and methods of use |
Jun, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11324734 | Compositions and methods for treating anemia |
Mar, 2036
(11 years from now) | Active |
| US11844756 | Compositions and methods for treating anemia |
Mar, 2036
(11 years from now) | Active |
| US9987262 | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof |
Nov, 2034
(9 years from now) | Active |
| US11857543 | Compositions and methods for treating anemia |
Jun, 2034
(9 years from now) | Active |
| US8323671 | Prolyl hydroxylase inhibitors and methods of use |
Apr, 2028
(3 years from now) | Active |
| US8940773 | Prolyl hydroxylase inhibitors and methods of use |
Jun, 2027
(2 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Vafseo's patents.
Latest Legal Activities on Vafseo's Patents
Given below is the list of recent legal activities going on the following patents of Vafseo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eCofC Notification | 11 Jun, 2024 | US8940773 |
| Patent eCofC Notification | 11 Jun, 2024 | US8940773 |
| Email Notification Critical | 11 Jun, 2024 | US8940773 |
| Recordation of Patent eCertificate of Correction | 11 Jun, 2024 | US8940773 |
| Initial letter Re: PTE Application to regulating agency | 21 May, 2024 | US8940773 |
| Post Issue Communication - Certificate of Correction | 21 May, 2024 | US8940773 |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US8940773 |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US7811595 (Litigated) |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US8343952 (Litigated) |
| Patent Term Extension Application under 35 USC 156 Filed | 17 May, 2024 | US8598210 (Litigated) |
FDA has granted several exclusivities to Vafseo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vafseo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vafseo.
Exclusivity Information
Vafseo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Vafseo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 27, 2029 |
US patents provide insights into the exclusivity only within the United States, but Vafseo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vafseo's family patents as well as insights into ongoing legal events on those patents.
Vafseo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vafseo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 31, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vafseo Generics:
There are no approved generic versions for Vafseo as of now.
About Vafseo
Vafseo is a drug owned by Akebia Therapeutics Inc. Vafseo uses Vadadustat as an active ingredient. Vafseo was launched by Akebia in 2024.
Approval Date:
Vafseo was approved by FDA for market use on 27 March, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vafseo is 27 March, 2024, its NCE-1 date is estimated to be 27 March, 2028.
Active Ingredient:
Vafseo uses Vadadustat as the active ingredient. Check out other Drugs and Companies using Vadadustat ingredient
Dosage:
Vafseo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG | TABLET | Prescription | ORAL |
| 150MG | TABLET | Prescription | ORAL |
| 450MG | TABLET | Prescription | ORAL |