clobetasol propionate · Quagen · NDA 022013
Olux E
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8460641.
FDA has approved 1 generic application (ANDA) for Olux E, though its earliest generic-entry date is 5 Nov 2028 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8460641 | drug product, use U-1410 · sets the listed date | 5 Nov 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
- Generic approved · ANDA 210638, Xiromed · 022013-001Approved 20 Nov 2025Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022013 · 001 · RLD · discontinued | aerosol, foam, topical | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 5 Nov 2028 |