tedizolid phosphate · Cubist Pharms Llc · NDA 205435, 205436
Sivextro
Earliest generic entry, as listed · earliest of 2 marketed strengths
31 Dec 2030
Blocked by patent: US 8426389.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8426389 | drug substance, drug product, use U-282 · sets the listed date | 31 Dec 2030 |
| US 10065947 | drug product | 3 Feb 2030 |
| US 10442829 | drug substance | 3 Feb 2030 |
| US 9624250 | drug substance, drug product, use U-2507 | 3 Feb 2030 |
| US 9988406 | drug product | 3 Feb 2030 |
| US 7816379 | drug substance, drug product, use U-2507 | 20 Jun 2028 |
| US 8420676 | drug substance, drug product, use U-282 | 23 Feb 2028 |
Exclusivities · 1 unexpired
| NPP | new patient population | 4 Apr 2028 |
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 |
|---|---|---|---|
| 205435 · 001 · RLD | tablet, oral | 200MG | 31 Dec 2030 |
| 205436 · 001 · RLD | powder, intravenous | 200MG/VIAL | 31 Dec 2030 |