zilucoplan sodium · Ucb Inc · NDA 216834
Zilbrysq
Earliest generic entry, as listed · earliest of 3 marketed strengths
12 Jun 2035
Blocked by patent: US 10106579, US 10208089, US 10435438, US 10562934, US 10835574, US 11014965, US 11535650, US 11752190, US 11965040.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10106579 | drug substance, drug product, use U-3735 · sets the listed date | 12 Jun 2035 |
| US 10208089 | drug substance, use U-3735 · sets the listed date | 12 Jun 2035 |
| US 10435438 | drug substance, use U-3735 · sets the listed date | 12 Jun 2035 |
| US 10562934 | drug substance · sets the listed date | 12 Jun 2035 |
| US 10835574 | drug product · sets the listed date | 12 Jun 2035 |
| US 11014965 | drug substance, use U-3735 · sets the listed date | 12 Jun 2035 |
| US 11535650 | drug product · sets the listed date | 12 Jun 2035 |
| US 11752190 | drug product, use U-3735 · sets the listed date | 12 Jun 2035 |
| US 11965040 | drug product · sets the listed date | 12 Jun 2035 |
Exclusivities · 2 unexpired
| ODE-446 | orphan drug (7 years) | 17 Oct 2030 |
| NCE | new chemical entity (5 years) | 17 Oct 2028 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216834 · 001 · RLD | solution, subcutaneous | EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML) | 12 Jun 2035 |
| 216834 · 002 · RLD | solution, subcutaneous | EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML) | 12 Jun 2035 |
| 216834 · 003 · RLD | solution, subcutaneous | EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML) | 12 Jun 2035 |