repotrectinib · Bristol · NDA 218213
Augtyro
Earliest generic entry, as listed · earliest of 2 marketed strengths
24 Jul 2036
Blocked by patent: US 11452725, US 11452725. 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 11452725 | use U-3755 | 24 Jul 2036 |
| US 11452725 | use U-3961 | 24 Jul 2036 |
| US 12310968 | use U-3755 | 20 Jul 2036 |
| US 10294242 | substance | 5 Jul 2036 |
| US 12187739 | product | 5 Jul 2036 |
| US RE50634 | substance, product | 23 Jan 2035 |
Exclusivities · 4 unexpired
| ODE-483 | orphan drug (7 years) | 13 Jun 2031 |
| ODE-455 | orphan drug (7 years) | 15 Nov 2030 |
| ODE* | 15 Nov 2030 | |
| NCE | new chemical entity (5 years) | 15 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218213 · 001 · RLD | capsule, oral | 40MG | 24 Jul 2036 |
| 218213 · 002 · RLD | capsule, oral | 160MG | 24 Jul 2036 |