encorafenib · Array Biopharma Inc · NDA 210496
Braftovi
Earliest generic entry, as listed
5 Aug 2033
Blocked by patent: US 9474754. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 13 unexpired
37 Orange Book listing rows for 13 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9474754 | use U-2802, U-4051, U-4440 | 5 Aug 2033 |
| US 9474754 listing row | use U-2802 · sets the listed date | 5 Aug 2033 |
| US 9474754 listing row | use U-4051 · sets the listed date | 5 Aug 2033 |
| US 9474754 listing row | use U-4440 · sets the listed date | 5 Aug 2033 |
| US 10258622 | use U-2802, U-4051, U-4439 | 21 Nov 2032 |
| US 10258622 listing row | use U-2802 | 21 Nov 2032 |
| US 10258622 listing row | use U-4051 | 21 Nov 2032 |
| US 10258622 listing row | use U-4439 | 21 Nov 2032 |
| US 9387208 | drug product | 21 Nov 2032 |
| US 9763941 | use U-2335 | 21 Nov 2032 |
| US 9314464 | use U-2336, U-2802, U-2803, U-3738, U-4051, U-4440 | 4 Jul 2031 |
| US 9314464 listing row | use U-2336 | 4 Jul 2031 |
| US 9314464 listing row | use U-2802 | 4 Jul 2031 |
| US 9314464 listing row | use U-2803 | 4 Jul 2031 |
| US 9314464 listing row | use U-3738 | 4 Jul 2031 |
| US 9314464 listing row | use U-4051 | 4 Jul 2031 |
| US 9314464 listing row | use U-4440 | 4 Jul 2031 |
| US 10005761 | use U-2335, U-2802, U-2803, U-3738, U-4051, U-4440 | 27 Aug 2030 |
| US 10005761 listing row | use U-2335 | 27 Aug 2030 |
| US 10005761 listing row | use U-2802 | 27 Aug 2030 |
| US 10005761 listing row | use U-2803 | 27 Aug 2030 |
| US 10005761 listing row | use U-3738 | 27 Aug 2030 |
| US 10005761 listing row | use U-4051 | 27 Aug 2030 |
| US 10005761 listing row | use U-4440 | 27 Aug 2030 |
| US 9593099 | drug substance | 27 Aug 2030 |
| US 9593100 | drug product | 27 Aug 2030 |
| US 9850229 | use U-2337 | 27 Aug 2030 |
| US 9850230 | use U-2334, U-2802, U-2803, U-3738, U-4051, U-4440 | 27 Aug 2030 |
| US 9850230 listing row | use U-2334 | 27 Aug 2030 |
| US 9850230 listing row | use U-2802 | 27 Aug 2030 |
| US 9850230 listing row | use U-2803 | 27 Aug 2030 |
| US 9850230 listing row | use U-3738 | 27 Aug 2030 |
| US 9850230 listing row | use U-4051 | 27 Aug 2030 |
| US 9850230 listing row | use U-4440 | 27 Aug 2030 |
| US RE49556 | drug substance, drug product | 27 Feb 2030 |
| US 8541575 | drug substance, drug product, use U-2335, U-2802, U-2803, U-3738, U-4051, U-4440 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-2335 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-2802 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-2803 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-3738 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-4051 | 26 Feb 2030 |
| US 8541575 listing row | drug substance, drug product, use U-4440 | 26 Feb 2030 |
| US 8946250 | drug substance, drug product | 23 Jul 2029 |
Exclusivities · 3 unexpired
| ODE-445 | orphan drug (7 years) | 11 Oct 2030 |
| I-997 | new indication (3 years) | 24 Feb 2029 |
| I-957 | new indication (3 years) | 20 Dec 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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210496 · 001 · RLD · discontinued | capsule, oral | 50MG | 21 Nov 2032 |
| 210496 · 002 · RLD | capsule, oral | 75MG | 5 Aug 2033 |
Expired or delisted (1)
- I-928 · 11 Oct 2026