mitapivat sulfate · Agios Pharms Inc · NDA 216196
Aqvesme
Earliest generic entry, as listed
31 Jul 2041
Blocked by patent: US 11878049. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11878049 | use U-4390 · sets the listed date | 31 Jul 2041 |
| US 11254652 | drug substance, drug product | 21 Nov 2038 |
| US RE49582 | drug substance, drug product | 11 Apr 2035 |
| US 9193701 | use U-4393 | 26 Oct 2032 |
| US 10632114 | use U-4391 | 3 May 2032 |
| US 9682080 | use U-4392 | 3 May 2032 |
Exclusivities · 3 unexpired
| ODE-522 | orphan drug (7 years) | 23 Dec 2032 |
| NP | new product | 23 Dec 2028 |
| NCE | new chemical entity (5 years) | 17 Feb 2027 |
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 |
|---|---|---|---|
| 216196 · 004 · RLD | tablet, oral | EQ 100MG BASE | 31 Jul 2041 |