omaveloxolone · Biogen Us · NDA 216718
Skyclarys
Earliest generic entry, as listed
24 Apr 2033
Blocked by patent: US 8993640, US 9701709.
Listed patents · 7 unexpired
8 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8993640 | drug substance, drug product · sets the listed date | 24 Apr 2033 |
| US 9701709 | drug substance, drug product · sets the listed date | 24 Apr 2033 |
| US 8124799 | drug substance | 3 Dec 2029 |
| US 11091430 | use U-3552 | 20 Apr 2029 |
| US 11919838 | use U-3862, U-3863 | 20 Apr 2029 |
| US 11919838 listing row | use U-3862 | 20 Apr 2029 |
| US 11919838 listing row | use U-3863 | 20 Apr 2029 |
| US 8440854 | drug product | 20 Apr 2029 |
| US 9670147 | drug substance | 20 Apr 2029 |
Exclusivities · 3 unexpired
| ODE-427 | orphan drug (7 years) | 28 Feb 2030 |
| NCE | new chemical entity (5 years) | 28 Feb 2028 |
| M-270 | miscellaneous (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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216718 · 001 · RLD | capsule, oral | 50MG | 24 Apr 2033 |