tapinarof · Organon Llc · NDA 215272
Vtama
Earliest generic entry, as listed
18 Dec 2039
Blocked by patent: US 12569453. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 12 unexpired
14 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12569453 | use U-4048 · sets the listed date | 18 Dec 2039 |
| US 11497718 | use U-4048 | 13 Nov 2039 |
| US 11590088 | use U-2625 | 13 Nov 2039 |
| US 11938099 | use U-4048 | 13 Nov 2039 |
| US 10647649 | drug substance | 13 Nov 2038 |
| US 11597692 | drug substance, drug product | 13 Nov 2038 |
| US 10195160 | drug product | 23 May 2036 |
| US 10426743 | use U-2625, U-4048 | 19 May 2036 |
| US 10426743 listing row | use U-2625 | 19 May 2036 |
| US 10426743 listing row | use U-4048 | 19 May 2036 |
| US 11458108 | drug product | 19 May 2036 |
| US 11612573 | use U-2625, U-4048 | 19 May 2036 |
| US 11612573 listing row | use U-2625 | 19 May 2036 |
| US 11612573 listing row | use U-4048 | 19 May 2036 |
| US 11617724 | drug product | 19 May 2036 |
| US 11622945 | drug product | 19 May 2036 |
Exclusivities · 2 unexpired
| I-956 | new indication (3 years) | 12 Dec 2027 |
| NCE | new chemical entity (5 years) | 23 May 2027 |
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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 215272 · 001 · RLD | cream, topical | 1% | 18 Dec 2039 |