adapalene; benzoyl peroxide · Galderma Labs Lp · NDA 022320
Epiduo
Earliest generic entry, as listed
18 Jul 2027
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8071644, US 8080537, US 8129362.
Listed patents · 3 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8071644 | drug product, use U-1078 · sets the listed date | 18 Jul 2027 |
| US 8080537 | use U-1078 · sets the listed date | 18 Jul 2027 |
| US 8129362 | use U-1078 · sets the listed date | 18 Jul 2027 |
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
- Enters 12-month window basis: patent · 022320-001Listed date 18 Jul 2027Detected 24 Oct 2026
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022320 · 001 · RLD · discontinued | gel, topical | 0.1%;2.5% | 18 Jul 2027 |