Orange Book product · Brand (NDA)
ZEPOSIA
OZANIMOD HYDROCHLORIDE
At a glance
Mar 25, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 25, 2020
6 yr 4 mo ago
Today
Exclusivity ends · M-309
New use / labeling-change exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
Patent 8796318 expires
Listed drug substance patent expiration.
May 14, 2029
in 2 yr 11 mo
Patent 9382217 expires
Listed method-of-use patent (U-2774) expiration.
May 14, 2029
in 2 yr 11 mo
Patent 10239846 expires
Listed method-of-use patent (U-3740) expiration.
Nov 15, 2030
in 4 yr 6 mo
Patent 8481573 expires
Listed drug substance patent expiration.
Mar 24, 2033
in 6 yr 10 mo
Patent 11680050 expires
Listed drug substance patent expiration.
Sep 30, 2038
in 12 yr 6 mo
Patent 11680050 expires
Listed drug substance patent expiration.
Sep 30, 2038
in 12 yr 6 mo
Pharmaceutical detail
Active ingredient
OZANIMOD HYDROCHLORIDE
Strength
EQ 0.92MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 209899
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- M-309New use / labeling-change exclusivity (3 years)
Aug 30, 2027
in 1 yr 3 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8796318 | May 14, 2029 | in 2 yr 11 mo | SubstanceProduct |
| 9382217 | May 14, 2029 | in 2 yr 11 mo | U-2774 |
| 10239846 | Nov 15, 2030 | in 4 yr 6 mo | U-3740 |
| 8481573 | Mar 24, 2033 | in 6 yr 10 mo | SubstanceProductU-2774 |
| 11680050 | Sep 30, 2038 | in 12 yr 6 mo | SubstanceProductU-2774 |
| 11680050 | Sep 30, 2038 | in 12 yr 6 mo | SubstanceProductU-3740 |
