dexmedetomidine hydrochloride · Hospira · NDA 021038
Precedex
Earliest generic entry, as listed · earliest of 5 marketed strengths
4 Jul 2032
2 of 5 marketed strengths have no unexpired patent or exclusivity listed.
Blocked by patent: US 8242158, US 8338470, US 8455527, US 8648106, US 9320712, US 9616049.
Listed patents · 13 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8242158 | — | 4 Jul 2032 |
| US 8338470 | — | 4 Jul 2032 |
| US 8455527 | — | 4 Jul 2032 |
| US 8648106 | — | 4 Jul 2032 |
| US 9320712 | — | 4 Jul 2032 |
| US 9616049 | — | 4 Jul 2032 |
| US 10016396 | product | 4 Jan 2032 |
| US 8242158 | product | 4 Jan 2032 |
| US 8338470 | product | 4 Jan 2032 |
| US 8455527 | use U-421 | 4 Jan 2032 |
| US 8648106 | product | 4 Jan 2032 |
| US 9320712 | product | 4 Jan 2032 |
| US 9616049 | product | 4 Jan 2032 |
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
- 25 Oct 2026Generic approved · 021038-00128 Sep 2026
- 25 Oct 2026Generic approved · 021038-00115 Apr 2026
- 25 Oct 2026Generic approved · 021038-0019 Mar 2026
- 25 Oct 2026Generic approved · 021038-00125 Feb 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021038 · 001 · RLD | injectable, injection | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | open |
| 021038 · 002 · RLD | injectable, injection | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | 4 Jul 2032 |
| 021038 · 003 · RLD | injectable, injection | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | 4 Jul 2032 |
| 021038 · 004 · RLD | injectable, injection | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | 4 Jul 2032 |
| 021038 · 005 · RLD | injectable, injection | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | open |