dexmedetomidine hydrochloride · Hq Spclt Pharma · NDA 206628
Dexmedetomidine Hydrochloride
Earliest generic entry, as listed · earliest of 4 marketed strengths
20 Apr 2036
2 of 4 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 9649296, US 9717796.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9649296 | drug product · sets the listed date | 20 Apr 2036 |
| US 9717796 | drug product · sets the listed date | 20 Apr 2036 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 206628 · 001 · RLD | solution, intravenous | EQ 400MCG BASE/4ML (EQ 100MCG BASE/ML) | open |
| 206628 · 002 · RLD | solution, intravenous | EQ 1MG BASE/10ML (EQ 100MCG BASE/ML) | open |
| 206628 · 003 · RLD | solution, intravenous | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | 20 Apr 2036 |
| 206628 · 004 · RLD | solution, intravenous | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | 20 Apr 2036 |