ingenol mebutate · Leo Labs · NDA 202833
Picato
Earliest generic entry, as listed · earliest of 2 marketed strengths
6 Jul 2027
Other strengths are listed to 15 May 2033; no marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8278292.
Listed patents · 12 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9789078 | use U-2138 | 15 May 2033 |
| US 8278292 | drug product · sets the listed date | 6 Jul 2027 |
| US 8372827 | drug product | 18 Dec 2026 |
| US 8372828 | drug product | 18 Dec 2026 |
| US 8377919 | drug product | 18 Dec 2026 |
| US 8536163 | use U-1440 | 18 Dec 2026 |
| US 8716271 | use U-1440 | 18 Dec 2026 |
| US 8735375 | use U-1440 | 18 Dec 2026 |
| US 9820959 | drug product, use U-1440 | 18 Dec 2026 |
| US 9833428 | drug product | 18 Dec 2026 |
| US 9833429 | drug product | 18 Dec 2026 |
| US 9861603 | use U-1440 | 18 Dec 2026 |
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 · 202833-002Listed date 6 Jul 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202833 · 001 · RLD · discontinued | gel, topical | 0.015% | 15 May 2033 |
| 202833 · 002 · RLD · discontinued | gel, topical | 0.05% | 6 Jul 2027 |