nirogacestat hydrobromide · Springworks · NDA 217677
Ogsiveo
Earliest generic entry, as listed · earliest of 2 marketed strengths
19 May 2043
Blocked by patent: US 11872211, US 11925619, US 11925620, US 11938116, US 11951096, US 11957662, US 12011434, US 12011435, US 12036207, US 12138246. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 29 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11872211 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11925619 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11925620 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11938116 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11951096 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11957662 | use U-3754 · sets the listed date | 19 May 2043 |
| US 12011434 | use U-3754 · sets the listed date | 19 May 2043 |
| US 12011435 | use U-3754 · sets the listed date | 19 May 2043 |
| US 12036207 | use U-3754 · sets the listed date | 19 May 2043 |
| US 12138246 | use U-3754 · sets the listed date | 19 May 2043 |
| US 11807611 | drug product, use U-3754 | 8 Sep 2042 |
| US 11844780 | drug product, use U-3754 | 8 Sep 2042 |
| US 11504354 | drug product | 8 Jul 2042 |
| US 11612588 | drug product, use U-3754 | 8 Jul 2042 |
| US 12110277 | drug product | 8 Jul 2042 |
| US 12234210 | drug product | 8 Jul 2042 |
| US 12247012 | drug product | 8 Jul 2042 |
| US 12599587 | drug product | 8 Jul 2042 |
| US 10590087 | drug substance | 9 Aug 2039 |
| US 10710966 | drug substance, use U-3754 | 9 Aug 2039 |
| US 10941118 | drug substance, use U-3754 | 9 Aug 2039 |
| US 11820748 | drug product | 9 Aug 2039 |
| US 11845732 | drug substance, use U-3754 | 9 Aug 2039 |
| US 11884634 | drug product | 9 Aug 2039 |
| US 11884635 | drug product | 9 Aug 2039 |
| US 11905255 | drug product | 9 Aug 2039 |
| US 12116347 | drug product | 9 Aug 2039 |
| US 12297177 | drug product | 9 Aug 2039 |
| US 7795447 | drug substance | 18 Aug 2030 |
Exclusivities · 3 unexpired
| ODE-452 | orphan drug (7 years) | 27 Nov 2030 |
| ODE* | 27 Nov 2030 | |
| NCE | new chemical entity (5 years) | 27 Nov 2028 |
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 |
|---|---|---|---|
| 217677 · 001 · RLD · discontinued | tablet, oral | EQ 50MG BASE | 19 May 2043 |
| 217677 · 002 · RLD | tablet, oral | EQ 100MG BASE | 19 May 2043 |
| 217677 · 003 · RLD | tablet, oral | EQ 150MG BASE | 19 May 2043 |