atrasentan hydrochloride · Novartis · NDA 219208
Vanrafia
Earliest generic entry, as listed
25 Mar 2043
Blocked by patent: US 12582631. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12582631 | use U-3980 · sets the listed date | 25 Mar 2043 |
| US 12521369 | use U-3980 | 2 Mar 2041 |
| US 11491137 | use U-3980 | 16 Dec 2040 |
| US 11998526 | use U-3980 | 16 Dec 2040 |
| US 12121509 | use U-3980 | 16 Dec 2040 |
| US 12370174 | use U-3980 | 16 Dec 2040 |
| US 10016393 | drug product | 7 Jul 2034 |
| US 9364458 | drug product, use U-3980 | 7 Jul 2034 |
| US 11874283 | use U-3980 | 18 Feb 2032 |
| US 8623819 | use U-3980 | 22 Aug 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 2 Apr 2030 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219208 · 001 · RLD | tablet, oral | EQ 0.75MG BASE | 25 Mar 2043 |