benzoyl peroxide; clindamycin phosphate · Bausch · NDA 050819
Acanya
Earliest generic entry, as listed
5 Aug 2029
Blocked by patent: US 8288434.
FDA has approved 1 generic application (ANDA) for Acanya, though its earliest generic-entry date is 5 Aug 2029 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 · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8288434 | drug product, use U-124 · sets the listed date | 5 Aug 2029 |
| US 10220049 | drug product, use U-916 | 3 Jun 2029 |
| US 10624918 | use U-916 | 3 Jun 2029 |
| US 8663699 | use U-124 | 3 Jun 2029 |
| US 8895070 | use U-124 | 3 Jun 2029 |
| US 9078870 | drug product | 3 Jun 2029 |
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 208757, Actavis Labs Ut Inc · 050819-001Approved 7 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050819 · 001 · RLD | gel, topical | 2.5%;EQ 1.2% BASE | 5 Aug 2029 |