FDA Orange Book
Is there a generic for Evrysdi?
Evrysdi contains risdiplam. 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 Evrysdi (risdiplam). The Orange Book shows its last listed patent expires April 15, 2041 and its last listed exclusivity ends May 27, 2029.
Run it in Rivvi
Map Evrysdi and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Evrysdi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for solution, oral | 0.75MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 213535, 219285, held by GENENTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Evrysdi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9586955 | February 8, 2033 | Drug substance, Drug product | None | 213535 |
| 9969754 | May 11, 2035 | Drug substance, Drug product | U-1943 | 213535 |
| 11827646 | January 25, 2036 | Method of use | U-1943 | 213535 |
| 11938136 | November 8, 2036 | Drug product | None | 213535 |
| 12350273 | October 1, 2038 | Method of use | U-1943 | 213535 |
| 11534444 | October 4, 2038 | Method of use | U-1943 | 213535 |
| 12122789 | April 15, 2041 | Drug substance, Drug product | None | 213535 |
Evrysdi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| M-270 | Miscellaneous | October 3, 2026 | 213535 |
| ODE-334 | Orphan drug exclusivity | August 7, 2027 | 213535 |
| ODE-400 | Orphan drug exclusivity | May 27, 2029 | 213535 |
Evrysdi NDC codes
Questions
Is there a generic for Evrysdi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Evrysdi (risdiplam). The Orange Book shows its last listed patent expires April 15, 2041 and its last listed exclusivity ends May 27, 2029.
What is the generic name for Evrysdi?
The active ingredient in Evrysdi is risdiplam, per the FDA Orange Book.
When does the Evrysdi patent expire?
The last patent listed for Evrysdi in the Orange Book expires April 15, 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.