dapsone · Almirall · NDA 021794, 207154
Aczone
1 of 2 marketed strengths has no unexpired patent or exclusivity listed.
Blocked by patent: US 11273132.
FDA has approved 1 generic application (ANDA) for Aczone, though its earliest generic-entry date is 18 Nov 2033 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 11273132 | drug product · sets the listed date | 18 Nov 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
- 25 Oct 2026Generic approved · 207154-00125 Jun 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021794 · 001 · RLD | gel, topical | 5% | open |
| 207154 · 001 · RLD | gel, topical | 7.5% | 18 Nov 2033 |