ozanimod hydrochloride · Bristol · NDA 209899
Zeposia
Earliest generic entry, as listed · earliest of 3 marketed strengths
30 Sep 2038
Blocked by patent: US 11680050.
Listed patents · 5 unexpired
6 Orange Book listing rows for 5 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11680050 | drug substance, drug product, use U-2774, U-3740 | 30 Sep 2038 |
| US 11680050 listing row | drug substance, drug product, use U-2774 · sets the listed date | 30 Sep 2038 |
| US 11680050 listing row | drug substance, drug product, use U-3740 · sets the listed date | 30 Sep 2038 |
| US 8481573 | drug substance, drug product, use U-2774 | 24 Mar 2033 |
| US 10239846 | use U-3740 | 15 Nov 2030 |
| US 8796318 | drug substance, drug product | 14 May 2029 |
| US 9382217 | use U-2774 | 14 May 2029 |
Exclusivities · 1 unexpired
| M-309 | miscellaneous (3 years) | 30 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209899 · 001 · RLD | capsule, oral | EQ 0.23MG BASE | 30 Sep 2038 |
| 209899 · 002 · RLD | capsule, oral | EQ 0.46MG BASE | 30 Sep 2038 |
| 209899 · 003 · RLD | capsule, oral | EQ 0.92MG BASE | 30 Sep 2038 |