thiotepa · Shorla · NDA 216984
Tepylute
Earliest generic entry, as listed · earliest of 2 marketed strengths
16 Aug 2041
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11975013, US 12622921.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11975013 | drug product · sets the listed date | 16 Aug 2041 |
| US 12622921 | use U-4530 · sets the listed date | 16 Aug 2041 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216984 · 001 · RLD · discontinued | solution, intravenous | 15MG/1.5ML (10MG/ML) | 16 Aug 2041 |
| 216984 · 002 · RLD · discontinued | solution, intravenous | 100MG/10ML (10MG/ML) | 16 Aug 2041 |