FDA Orange Book
Is there a generic for Radicava Ors?
Radicava Ors contains edaravone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Radicava Ors (edaravone). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends May 12, 2029.
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Radicava Ors products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, oral | 105MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 215446, held by SHIONOGI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Radicava Ors patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11478450 | November 1, 2039 | Method of use | U-3468 | 215446 |
| 10987341 | November 1, 2039 | Drug product | None | 215446 |
| 12285409 | November 1, 2039 | Drug product | None | 215446 |
| 12599586 | November 1, 2039 | Drug product | None | 215446 |
| 11241416 | November 1, 2039 | Drug product | None | 215446 |
| 11957660 | November 1, 2039 | Drug product | None | 215446 |
| 11826352 | November 1, 2039 | Drug product | None | 215446 |
| 12310946 | November 12, 2041 | Method of use | U-4111 | 215446 |
| 12569469 | November 12, 2041 | Method of use | U-4111 | 215446 |
| 12527769 | November 12, 2041 | Method of use | U-4111 | 215446 |
| 12194025 | November 12, 2041 | Method of use | U-4111 | 215446 |
| 12478611 | November 12, 2041 | Method of use | U-4111 | 215446 |
Radicava Ors exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-144 | Orphan drug exclusivity | May 12, 2029 | 215446 |
Questions
Is there a generic for Radicava Ors?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Radicava Ors (edaravone). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends May 12, 2029.
What is the generic name for Radicava Ors?
The active ingredient in Radicava Ors is edaravone, per the FDA Orange Book.
When does the Radicava Ors patent expire?
The last patent listed for Radicava Ors in the Orange Book expires November 12, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.