calcipotriene · Mayne Pharma · NDA 022563
Sorilux
Earliest generic entry, as listed
7 May 2028
Blocked by patent: US 8263580.
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8263580 | drug product, use U-1280, U-2662 | 7 May 2028 |
| US 8263580 listing row | drug product, use U-1280 · sets the listed date | 7 May 2028 |
| US 8263580 listing row | drug product, use U-2662 · sets the listed date | 7 May 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 |
|---|---|---|---|
| 022563 · 001 · RLD | aerosol, foam, topical | 0.005% | 7 May 2028 |
Expired or delisted (3)
- US 8629128 · product, use U-1280 · 26 May 2026
- US 8629128 · product, use U-1767 · 26 May 2026
- US 8629128 · product, use U-2662 · 26 May 2026