FDA Orange Book · active-ingredient family
Risdiplam
Risdiplam is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:EVRYSDI · NDA 219285
2
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
4
Exclusivity periods
Brand (NDA) products · for solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EVRYSDIRLD | GENENTECH INC | NDA 219285 | — | Feb 11, 2025 | |
| EVRYSDIRLD | GENENTECH INC | NDA 213535 | — | Aug 07, 2020 |
Marketing exclusivity (4)
- M-270New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
- ODE-334Orphan-drug exclusivity (7 years)
Aug 07, 2027
in 1 yr 2 mo
- ODE-400Orphan-drug exclusivity (7 years)
May 27, 2029
in 3 yr
- M-270New use / labeling-change exclusivity (3 years)
Oct 03, 2026
in 4 mo
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9586955 | Feb 08, 2033 | in 6 yr 9 mo | SubstanceProduct |
| 9969754 | May 11, 2035 | in 9 yr | SubstanceProductU-1943 |
| 11827646 | Jan 25, 2036 | in 9 yr 9 mo | U-1943 |
| 11938136 | Nov 08, 2036 | in 10 yr 7 mo | Product |
| 12350273 | Oct 01, 2038 | in 12 yr 6 mo | U-1943 |
| 11534444 | Oct 04, 2038 | in 12 yr 6 mo | U-1943 |
| 12122789 | Apr 15, 2041 | in 15 yr | SubstanceProduct |
Risdiplam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
