mitapivat sulfate · Agios Pharms Inc · NDA 216196
Pyrukynd
Earliest generic entry, as listed · earliest of 3 marketed strengths
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 · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11878049 | use U-3782 · sets the listed date | 31 Jul 2041 |
| US 11254652 | drug substance, drug product | 21 Nov 2038 |
| US 11234976 | use U-3321 | 11 Oct 2038 |
| US RE49582 | drug substance, drug product | 11 Apr 2035 |
| US 11793806 | use U-3320 | 12 Apr 2033 |
| US 9193701 | use U-3319 | 26 Oct 2032 |
| US 10632114 | use U-3320 | 3 May 2032 |
| US 9682080 | use U-3319 | 3 May 2032 |
| US 9980961 | use U-3319 | 3 May 2032 |
Exclusivities · 2 unexpired
| ODE-392 | orphan drug (7 years) | 17 Feb 2029 |
| 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216196 · 001 · RLD | tablet, oral | EQ 5MG BASE | 31 Jul 2041 |
| 216196 · 002 · RLD | tablet, oral | EQ 20MG BASE | 31 Jul 2041 |
| 216196 · 003 · RLD | tablet, oral | EQ 50MG BASE | 31 Jul 2041 |