thiotepa · Adienne Sa · NDA 208264
Tepadina And Sodium Chloride
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 May 2037
Blocked by patent: US 9931458.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9931458 | product | 31 May 2037 |
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 |
|---|---|---|---|
| 208264 · 003 · RLD | powder, intravenous | 200MG | 31 May 2037 |
| 208264 · 004 · RLD | powder, intravenous | 400MG | 31 May 2037 |