gedatolisib · Celcuity · NDA 219908
Revtorpyk
Earliest generic entry, as listed
14 Jul 2031
Blocked by exclusivity: NCE.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 1 unexpired
| NCE | new chemical entity (5 years) | 14 Jul 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 |
|---|---|---|---|
| 219908 · 001 · RLD | powder, intravenous | 180MG/VIAL | 14 Jul 2031 |