halobetasol propionate · Lacer Pharma · NDA 019967, 019968, 208183
Ultravate
Earliest generic entry, as listed
19 Jun 2033
Blocked by patent: US 8962028.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8962028 | drug product, use U-1775 · sets the listed date | 19 Jun 2033 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 019967 · 001 · RLD · discontinued | cream, topical | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019968 · 001 · RLD · discontinued | ointment, topical | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 208183 · 001 · RLD | lotion, topical | 0.05% | 19 Jun 2033 |