Orange Book product · Brand (NDA)
PRECEDEX
DEXMEDETOMIDINE HYDROCHLORIDE
At a glance
Mar 13, 2013
Approved
Brand (NDA)
Application
AP
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 13, 2013
13 yr 6 mo ago
Today
Patent 10016396 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 8242158 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 8338470 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 8455527 expires
Listed method-of-use patent (U-421) expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 8648106 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 9320712 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 9616049 expires
Listed drug product patent expiration.
Jan 04, 2032
in 5 yr 8 mo
Patent 8242158*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Patent 8338470*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Patent 8455527*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Patent 8648106*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Patent 9320712*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Patent 9616049*PED expires
Listed listed patent expiration.
Jul 04, 2032
in 6 yr 2 mo
Pharmaceutical detail
Active ingredient
DEXMEDETOMIDINE HYDROCHLORIDE
Strength
EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 021038
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2022IGALMIBrand (NDA)
NDA 215390 · BIOXCEL
- 2015DEXMEDETOMIDINE HYDROCHLORIDEBrand (NDA)
NDA 206628 · HQ SPCLT PHARMA
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 208103 · BAXTER HLTHCARE CORP
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218675 · KNACK
- 2026DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220315 · DR REDDYS
- 2025DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206407 · HIKMA
- 2024DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 218112 · SOMERSET
- 2023DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217308 · MILLA PHARMS
- 2023DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 216604 · AMNEAL
- 2021DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 214794 · PIRAMAL CRITICAL
- 2020DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210321 · EUGIA PHARMA
- 2020DEXMEDETOMIDINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212857 · TAGI
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10016396 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 8242158 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 8338470 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 8455527 | Jan 04, 2032 | in 5 yr 8 mo | U-421 |
| 8648106 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 9320712 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 9616049 | Jan 04, 2032 | in 5 yr 8 mo | Product |
| 8242158*PED | Jul 04, 2032 | in 6 yr 2 mo | |
| 8338470*PED | Jul 04, 2032 | in 6 yr 2 mo | |
| 8455527*PED | Jul 04, 2032 | in 6 yr 2 mo | |
| 8648106*PED | Jul 04, 2032 | in 6 yr 2 mo | |
| 9320712*PED | Jul 04, 2032 | in 6 yr 2 mo | |
| 9616049*PED | Jul 04, 2032 | in 6 yr 2 mo |
