vadadustat · Akebia · NDA 215192
Vafseo
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Mar 2036
Blocked by patent: US 11324734, US 11844756.
Listed patents · 14 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11324734 | drug product · sets the listed date | 31 Mar 2036 |
| US 11844756 | use U-3876 · sets the listed date | 31 Mar 2036 |
| US 10149842 | drug substance, drug product | 14 Nov 2034 |
| US 11065237 | drug substance, drug product, use U-3876 | 14 Nov 2034 |
| US 9701636 | drug substance, drug product | 14 Nov 2034 |
| US 9987262 | use U-3876 | 14 Nov 2034 |
| US 11857543 | use U-3876 | 9 Jun 2034 |
| US 12569474 | use U-3876 | 4 Jun 2034 |
| US 8323671 | use U-3876 | 3 Apr 2028 |
| US 7811595 | drug substance, drug product | 13 Mar 2028 |
| US 8343952 | drug substance, drug product | 14 Aug 2027 |
| US 8598210 | drug substance, drug product | 26 Jun 2027 |
| US 8940773 | use U-3876 | 26 Jun 2027 |
| US RE47437 | drug substance, drug product | 26 Jun 2027 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 27 Mar 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215192 · 001 · RLD | tablet, oral | 150MG | 31 Mar 2036 |
| 215192 · 002 · RLD | tablet, oral | 300MG | 31 Mar 2036 |
| 215192 · 003 · RLD · discontinued | tablet, oral | 450MG | 31 Mar 2036 |