clobetasol propionate · Primus Pharms · NDA 209483
Impoyz
Earliest generic entry, as listed
11 Mar 2035
Blocked by patent: US 9855334.
Listed patents · 5 unexpired
14 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9855334 | drug product · sets the listed date | 11 Mar 2035 |
| US 10064875 | drug product, use U-1408, U-1858, U-193, U-742, U-88 | 31 Aug 2030 |
| US 10064875 listing row | drug product, use U-1408 | 31 Aug 2030 |
| US 10064875 listing row | drug product, use U-1858 | 31 Aug 2030 |
| US 10064875 listing row | drug product, use U-193 | 31 Aug 2030 |
| US 10064875 listing row | drug product, use U-742 | 31 Aug 2030 |
| US 10064875 listing row | drug product, use U-88 | 31 Aug 2030 |
| US 10588914 | drug product, use U-2771 | 31 Aug 2030 |
| US 11179465 | drug product, use U-1858 | 31 Aug 2030 |
| US 9956231 | drug product, use U-1408, U-1761, U-1858, U-193, U-742, U-88 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-1408 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-1761 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-1858 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-193 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-742 | 31 Aug 2030 |
| US 9956231 listing row | drug product, use U-88 | 31 Aug 2030 |
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 |
|---|---|---|---|
| 209483 · 001 · RLD | cream, topical | 0.025% | 11 Mar 2035 |