risdiplam · Genentech Inc · NDA 213535, 219285
Evrysdi
Earliest generic entry, as listed · earliest of 2 marketed strengths
15 Apr 2041
Blocked by patent: US 12122789.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12122789 | substance, product | 15 Apr 2041 |
| US 11534444 | use U-1943 | 4 Oct 2038 |
| US 12350273 | use U-1943 | 1 Oct 2038 |
| US 11938136 | product | 8 Nov 2036 |
| US 11827646 | use U-1943 | 25 Jan 2036 |
| US 9969754 | substance, product, use U-1943 | 11 May 2035 |
| US 9586955 | substance, product | 8 Feb 2033 |
Exclusivities · 2 unexpired
| ODE-400 | orphan drug (7 years) | 27 May 2029 |
| ODE-334 | orphan drug (7 years) | 7 Aug 2027 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 213535 · 001 · RLD | for solution, oral | 0.75MG/ML | 15 Apr 2041 |
| 219285 · 001 · RLD | tablet, oral | 5MG | 15 Apr 2041 |
Expired or delisted (1)
- M-270 · 3 Oct 2026