sodium phenylbutyrate; taurursodiol · Amylyx · NDA 216660
Relyvrio
Earliest generic entry, as listed
27 Jul 2040
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11583542.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11583542 | drug product · sets the listed date | 27 Jul 2040 |
| US 10251896 | use U-3460 | 24 Dec 2033 |
| US 10857162 | use U-3460 | 24 Dec 2033 |
| US 11071742 | drug product | 24 Dec 2033 |
| US 9872865 | use U-3460 | 24 Dec 2033 |
Exclusivities · 2 unexpired
| ODE-411 | orphan drug (7 years) | 29 Sep 2029 |
| NCE | new chemical entity (5 years) | 29 Sep 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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216660 · 001 · RLD · discontinued | for suspension, oral | 3GM/PACKET; 1GM/PACKET | 27 Jul 2040 |