vancomycin hydrochloride · Hikma · NDA 211962
Tyzavan
Earliest generic entry, as listed · earliest of 7 marketed strengths
6 Nov 2035
Blocked by patent: US 10039804, US 10188697, US 10849956, US 11517609, US 11628200, US 12161690.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10039804 | drug product, use U-282 · sets the listed date | 6 Nov 2035 |
| US 10188697 | drug product, use U-282 · sets the listed date | 6 Nov 2035 |
| US 10849956 | drug product · sets the listed date | 6 Nov 2035 |
| US 11517609 | use U-282 · sets the listed date | 6 Nov 2035 |
| US 11628200 | drug product · sets the listed date | 6 Nov 2035 |
| US 12161690 | drug product · sets the listed date | 6 Nov 2035 |
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 · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211962 · 001 · RLD | solution, intravenous | EQ 500MG BASE/100ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 002 · RLD | solution, intravenous | EQ 1GM BASE/200ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 003 · RLD | solution, intravenous | EQ 1.5GM BASE/300ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 004 · RLD | solution, intravenous | EQ 2GM BASE/400ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 005 · RLD | solution, intravenous | EQ 750MG BASE/150ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 006 · RLD | solution, intravenous | EQ 1.25GM BASE/250ML (EQ 5MG BASE/ML) | 6 Nov 2035 |
| 211962 · 007 · RLD | solution, intravenous | EQ 1.75GM BASE/350ML (EQ 5MG BASE/ML) | 6 Nov 2035 |