entrectinib · Genentech Inc · NDA 212725, 218550
Rozlytrek
Earliest generic entry, as listed · earliest of 3 marketed strengths
20 Oct 2030
Other strengths are listed to 18 Jul 2038.
Blocked by exclusivity: ODE-448.
Listed patents · 14 unexpired
19 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10398693 | drug product | 18 Jul 2038 |
| US 11253515 | drug product | 18 Jul 2038 |
| US 10738037 | drug substance, drug product, use U-2946 | 18 May 2037 |
| US 11091469 | use U-2617, U-2618 | 18 May 2037 |
| US 11091469 listing row | use U-2617 | 18 May 2037 |
| US 11091469 listing row | use U-2618 | 18 May 2037 |
| US 10561651 | use U-2745 | 19 Feb 2035 |
| US 10231965 | use U-2617, U-2618 | 17 Feb 2035 |
| US 10231965 listing row | use U-2617 | 17 Feb 2035 |
| US 10231965 listing row | use U-2618 | 17 Feb 2035 |
| US 9085565 | drug substance, drug product | 22 May 2033 |
| US 9649306 | use U-2617, U-2618 | 22 May 2033 |
| US 9649306 listing row | use U-2617 | 22 May 2033 |
| US 9649306 listing row | use U-2618 | 22 May 2033 |
| US 8299057 | drug substance, drug product | 10 Mar 2032 |
| US 8673893 | use U-2617, U-2618 | 8 Jul 2028 |
| US 8673893 listing row | use U-2617 | 8 Jul 2028 |
| US 8673893 listing row | use U-2618 | 8 Jul 2028 |
| US 9029356 | drug substance, drug product | 8 Jul 2028 |
| US 9085558 | drug product | 8 Jul 2028 |
| US 9255087 | use U-2617, U-2618 | 8 Jul 2028 |
| US 9255087 listing row | use U-2617 | 8 Jul 2028 |
| US 9255087 listing row | use U-2618 | 8 Jul 2028 |
| US 9616059 | use U-2618 | 8 Jul 2028 |
Exclusivities · 1 unexpired
| ODE-448 | orphan drug (7 years) | 20 Oct 2030 |
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 |
|---|---|---|---|
| 212725 · 001 · RLD | capsule, oral | 100MG | 18 Jul 2038 |
| 212725 · 002 · RLD | capsule, oral | 200MG | 18 Jul 2038 |
| 218550 · 001 · RLD | pellets, oral | 50MG/PACKET | 20 Oct 2030 |
Expired or delisted (5)
- NPP · 20 Oct 2026
- NP · 20 Oct 2026
- ODE-313 · 15 Aug 2026
- ODE-265 · 15 Aug 2026
- ODE* · 15 Aug 2026