sirolimus · Nobelpharma · NDA 213478
Hyftor
Earliest generic entry, as listed
11 Apr 2045
Blocked by patent: US 12740970.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12740970 | drug product · sets the listed date | 11 Apr 2045 |
Exclusivities · 1 unexpired
| ODE-391 | orphan drug (7 years) | 22 Mar 2029 |
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 |
|---|---|---|---|
| 213478 · 001 · RLD | gel, topical | 0.2% | 11 Apr 2045 |