iloprost · Btg Intl · NDA 217933
Aurlumyn
Earliest generic entry, as listed
18 Jul 2044
Blocked by patent: US 12409183. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12409183 | use U-4263 · sets the listed date | 18 Jul 2044 |
| US 12409184 | drug product | 6 Aug 2041 |
Exclusivities · 2 unexpired
| ODE-465 | orphan drug (7 years) | 13 Feb 2031 |
| NP | new product | 13 Feb 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 |
|---|---|---|---|
| 217933 · 001 · RLD | solution, intravenous | 100MCG/ML (100MCG/ML) | 18 Jul 2044 |