FDA Orange Book · active-ingredient family
Edaravone
Edaravone is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RADICAVA ORS · NDA 215446
2
Brand (NDA)
6
Generics (ANDA)
12
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RADICAVA ORSRLD | SHIONOGI | NDA 215446 | — | May 12, 2022 | |
| RADICAVARLD×2 | SHIONOGI | NDA 209176 | — | May 05, 2017 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EDARAVONE | SANDOZ | ANDA 216902 | AP | Dec 23, 2024 | |
| EDARAVONE×2 | PHARMOBEDIENT | ANDA 217565 | AP | Oct 31, 2024 | |
| EDARAVONE | DR REDDYS | ANDA 215917 | — | May 06, 2024 | |
| EDARAVONE×2 | GLAND | ANDA 216199 | AP | May 06, 2024 | |
| EDARAVONE | HIKMA | ANDA 215508 | AP | May 06, 2024 | |
| EDARAVONE | LONG GROVE PHARMS | ANDA 218354 | — | May 06, 2024 |
Marketing exclusivity (1)
- ODE-144Orphan-drug exclusivity (7 years)
May 12, 2029
in 2 yr 11 mo
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11478450 | Nov 01, 2039 | in 13 yr 7 mo | U-3468 |
| 10987341 | 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 |
| 11241416 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 11957660 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 11826352 | Nov 01, 2039 | in 13 yr 7 mo | Product |
| 12310946 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12569469 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12527769 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12194025 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
| 12478611 | Nov 12, 2041 | in 15 yr 8 mo | U-4111 |
Edaravone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
