difamilast · Acrotech Biopharma · NDA 219474
Adquey
Earliest generic entry, as listed
31 Dec 2036
Blocked by patent: US 10588893.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10588893 | drug substance, drug product · sets the listed date | 31 Dec 2036 |
| US RE46792 | drug substance, drug product, use U-4445 | 1 Mar 2028 |
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 12 Feb 2031 |
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 |
|---|---|---|---|
| 219474 · 001 · RLD | ointment, topical | 1% | 31 Dec 2036 |