Orange Book product · Brand (NDA)
RADICAVA ORS
EDARAVONE
At a glance
May 12, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
12
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 12, 2022
4 yr 2 mo ago
Today
Exclusivity ends · ODE-144
Orphan-drug exclusivity (7 years)
May 12, 2029
in 2 yr 11 mo
Patent 10987341 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11241416 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11478450 expires
Listed method-of-use patent (U-3468) expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11826352 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 11957660 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12285409 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12599586 expires
Listed drug product patent expiration.
Nov 01, 2039
in 13 yr 7 mo
Patent 12194025 expires
Listed method-of-use patent (U-4111) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12310946 expires
Listed method-of-use patent (U-4111) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12478611 expires
Listed method-of-use patent (U-4111) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12527769 expires
Listed method-of-use patent (U-4111) expiration.
Nov 12, 2041
in 15 yr 8 mo
Patent 12569469 expires
Listed method-of-use patent (U-4111) expiration.
Nov 12, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
EDARAVONE
Strength
105MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 215446
Product number
001
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.
- 2017RADICAVABrand (NDA)
NDA 209176 · SHIONOGI
- 2024EDARAVONEGeneric (ANDA)
ANDA 216902 · SANDOZ
- 2024EDARAVONEGeneric (ANDA)
ANDA 217565 · PHARMOBEDIENT
- 2024EDARAVONEGeneric (ANDA)
ANDA 215917 · DR REDDYS
- 2024EDARAVONEGeneric (ANDA)
ANDA 216199 · GLAND
- 2024EDARAVONEGeneric (ANDA)
ANDA 215508 · HIKMA
- 2024EDARAVONEGeneric (ANDA)
ANDA 218354 · LONG GROVE PHARMS
Marketing exclusivity (1)
- ODE-144Orphan-drug exclusivity (7 years)
May 12, 2029
in 2 yr 11 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10987341 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 11241416 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 11478450 | Nov 01, 2039 | in 13 yr 7 mo | U-3468 |
| 11826352 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 11957660 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 12285409 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 12599586 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 12194025 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12310946 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12478611 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12527769 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12569469 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
