FDA Orange Book · active-ingredient family
Edaravone
Edaravone: 2 brands, 6 generics; first approved May 05, 2017; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
12
Next patent expiry
Nov 01, 2039
in 13 yr 5 mo
Brand (NDA) products
Originator applications
- SHIONOGINDA 2154462022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 105MG/5ML SUSPENSION ORAL Rx — - RADICAVARLDSHIONOGINDA 20917620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Discontinued — 60MG/100ML (0.6MG/ML) SOLUTION INTRAVENOUS Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- EDARAVONESANDOZANDA 2169022024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Rx AP - EDARAVONEPHARMOBEDIENTANDA 21756520242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Discontinued — 60MG/100ML (0.6MG/ML) SOLUTION INTRAVENOUS Discontinued — - EDARAVONEDR REDDYSANDA 2159172024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/100ML (0.6MG/ML) SOLUTION INTRAVENOUS Discontinued — - EDARAVONERSGLANDANDA 21619920242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Rx AP 60MG/100ML (0.6MG/ML) SOLUTION INTRAVENOUS Discontinued — - EDARAVONEHIKMAANDA 2155082024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Rx AP - EDARAVONELONG GROVE PHARMSANDA 2183542024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/100ML (0.3MG/ML) SOLUTION INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-144Orphan-drug exclusivity (7 years)
in 2 yr 9 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11478450 | in 13 yr 5 mo | U-3468 | |
| 10987341 | in 13 yr 5 mo | Product | |
| 12285409 | in 13 yr 5 mo | Product | |
| 12599586 | in 13 yr 5 mo | Product | |
| 11241416 | in 13 yr 5 mo | Product | |
| 11957660 | in 13 yr 5 mo | Product | |
| 11826352 | in 13 yr 5 mo | Product | |
| 12310946 | in 15 yr 6 mo | U-4111 | |
| 12569469 | in 15 yr 6 mo | U-4111 | |
| 12527769 | in 15 yr 6 mo | U-4111 | |
| 12194025 | in 15 yr 6 mo | U-4111 | |
| 12478611 | in 15 yr 6 mo | U-4111 |
Approval history
FDA approval span
First approval
9 yr 5 mo ago
Most recent approval
1 yr 8 mo ago
Approvals span 2017–2024 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Edaravone: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
