halobetasol propionate · Bausch · NDA 209355
Bryhali
Earliest generic entry, as listed
2 Nov 2031
Blocked by patent: US 10478502, US 11839656, US 11957753, US 11986527, US 12076403, US 8809307.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10478502 | drug product, use U-2625 · sets the listed date | 2 Nov 2031 |
| US 11839656 | use U-2625 · sets the listed date | 2 Nov 2031 |
| US 11957753 | drug product · sets the listed date | 2 Nov 2031 |
| US 11986527 | use U-2625 · sets the listed date | 2 Nov 2031 |
| US 12076403 | drug product · sets the listed date | 2 Nov 2031 |
| US 8809307 | drug product · sets the listed date | 2 Nov 2031 |
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 |
|---|---|---|---|
| 209355 · 001 · RLD | lotion, topical | 0.01% | 2 Nov 2031 |