iptacopan hydrochloride · Novartis · NDA 218276
Fabhalta
Earliest generic entry, as listed
15 Jul 2041
Blocked by patent: US 11951101, US 12453726. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 8 unexpired
10 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11951101 | use U-3895 · sets the listed date | 15 Jul 2041 |
| US 12453726 | use U-4300 · sets the listed date | 15 Jul 2041 |
| US 11603363 | drug substance, drug product | 25 May 2041 |
| US 12384758 | use U-3980, U-4161 | 17 May 2041 |
| US 12384758 listing row | use U-3980 | 17 May 2041 |
| US 12384758 listing row | use U-4161 | 17 May 2041 |
| US 11723901 | use U-3980 | 30 Aug 2038 |
| US 12285422 | use U-4181 | 30 Aug 2038 |
| US 10093663 | use U-3980, U-4161 | 14 Jul 2034 |
| US 10093663 listing row | use U-3980 | 14 Jul 2034 |
| US 10093663 listing row | use U-4161 | 14 Jul 2034 |
| US 9682968 | drug substance, drug product | 14 Jul 2034 |
Exclusivities · 5 unexpired
| ODE-524 | orphan drug (7 years) | 20 Mar 2032 |
| ODE-456 | orphan drug (7 years) | 5 Dec 2030 |
| NCE | new chemical entity (5 years) | 5 Dec 2028 |
| I-963 | new indication (3 years) | 20 Mar 2028 |
| I-949 | new indication (3 years) | 7 Aug 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 218276 · 001 · RLD | capsule, oral | EQ 200MG BASE | 15 Jul 2041 |