halobetasol propionate; tazarotene · Bausch · NDA 209354
Duobrii
Earliest generic entry, as listed
6 Jun 2036
Blocked by patent: US 10251895, US 10426787, US 11648256, US 11679115.
Listed patents · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10251895 | drug product · sets the listed date | 6 Jun 2036 |
| US 10426787 | use U-2625 · sets the listed date | 6 Jun 2036 |
| US 11648256 | drug product, use U-2625 · sets the listed date | 6 Jun 2036 |
| US 11679115 | drug product, use U-2625 · sets the listed date | 6 Jun 2036 |
| US 10478502 | drug product, use U-2625 | 2 Nov 2031 |
| US 11839656 | use U-2625 | 2 Nov 2031 |
| US 11957753 | drug product | 2 Nov 2031 |
| US 11986527 | use U-2625 | 2 Nov 2031 |
| US 12076403 | drug product | 2 Nov 2031 |
| US 8809307 | drug product | 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 |
|---|---|---|---|
| 209354 · 001 · RLD | lotion, topical | 0.01%;0.045% | 6 Jun 2036 |