efinaconazole · Bausch · NDA 203567
Jublia
Earliest generic entry, as listed
25 Apr 2035
Blocked by patent: US 10478601.
FDA has approved 1 generic application (ANDA) for Jublia, though its earliest generic-entry date is 25 Apr 2035 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 · 17 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10478601 | drug product, use U-2721 · sets the listed date | 25 Apr 2035 |
| US 10342875 | drug product, use U-2720 | 2 Oct 2034 |
| US 10828293 | use U-2720 | 2 Oct 2034 |
| US 10864274 | use U-2720 | 2 Oct 2034 |
| US 11654139 | use U-1969 | 2 Oct 2034 |
| US 9662394 | drug product | 2 Oct 2034 |
| US 8486978 | drug product | 24 Oct 2030 |
| US 9302009 | drug product | 24 Oct 2030 |
| US 10105444 | drug product | 8 Jul 2030 |
| US 8039494 | use U-281 | 8 Jul 2030 |
| US 9861698 | drug product | 8 Jul 2030 |
| US 10512640 | use U-1969 | 3 Jan 2028 |
| US 10828369 | drug product | 3 Jan 2028 |
| US 11213519 | use U-2720 | 3 Jan 2028 |
| US 11872218 | use U-1969 | 3 Jan 2028 |
| US 9566272 | use U-1969 | 3 Jan 2028 |
| US 9877955 | use U-1969 | 3 Jan 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
- 25 Oct 2026Generic approved · 203567-00123 Feb 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 203567 · 001 · RLD | solution, topical | 10% | 25 Apr 2035 |
Expired or delisted (1)
- US 7214506 · use U-281 · 22 Feb 2026