Orange Book product · Brand (NDA)
BRIDION
SUGAMMADEX SODIUM
At a glance
Dec 15, 2015
Approved
Brand (NDA)
Application
AP
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 15, 2015
10 yr 8 mo ago
Patent RE44733 expires
Listed drug substance patent expiration.
Jan 27, 2026
5 mo ago
Today
Patent RE44733*PED expires
Listed listed patent expiration.
Jul 27, 2026
in 1 mo
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 12, 2027
in 1 yr 6 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 12, 2028
in 2 yr
Pharmaceutical detail
Active ingredient
SUGAMMADEX SODIUM
Strength
EQ 200MG BASE/2ML (EQ 100MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022225
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Marketing exclusivity (2)
- NPPNew patient population exclusivity (3 years)
Dec 12, 2027
in 1 yr 6 mo
- PEDPediatric exclusivity (adds 6 months)
Jun 12, 2028
in 2 yr
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE44733 | Jan 27, 2026 | 5 mo ago | SubstanceProductU-1794 |
| RE44733*PED | Jul 27, 2026 | in 1 mo |
