piflufolastat f-18 · Aphelion · NDA 220089
Pylarify Truvu
Earliest generic entry, as listed
9 Jun 2037
Blocked by patent: US 10947197, US 11851407.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10947197 | drug substance, drug product, use U-3317 · sets the listed date | 9 Jun 2037 |
| US 11851407 | drug substance, drug product, use U-3317 · sets the listed date | 9 Jun 2037 |
| US 8778305 | drug substance, drug product, use U-3317 | 21 Sep 2030 |
| US 12070513 | drug substance, drug product, use U-3317 | 31 Jul 2029 |
| US 9861713 | drug substance, drug product, use U-3317 | 31 Jul 2029 |
| US 8487129 | drug substance, drug product | 7 Nov 2027 |
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
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 |
|---|---|---|---|
| 220089 · 001 · RLD | solution, intravenous | 1mCi/mL-120mCi/mL | 9 Jun 2037 |
Expired or delisted (1)
- NCE · 26 May 2026