inavolisib · Genentech Inc · NDA 219249
Itovebi
Earliest generic entry, as listed · earliest of 2 marketed strengths
14 Jun 2038
Blocked by patent: US 12410189. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12410189 | use U-4024 | 14 Jun 2038 |
| US 11028100 | substance, product | 26 Apr 2038 |
| US 10851091 | substance, product | 1 Jul 2036 |
| US 11760753 | use U-4024 | 1 Jul 2036 |
| US 9650393 | substance, product, use U-4024 | 1 Jul 2036 |
| US 8242104 | substance, product | 27 Sep 2030 |
| US 8343955 | use U-4024 | 27 Sep 2030 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 10 Oct 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 219249 · 001 · RLD | tablet, oral | 3MG | 14 Jun 2038 |
| 219249 · 002 · RLD | tablet, oral | 9MG | 14 Jun 2038 |