Orange Book product · Brand (NDA)
LUPKYNIS
VOCLOSPORIN
At a glance
Jan 22, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 22, 2021
5 yr 6 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 22, 2026
5 mo ago
Today
Patent 7332472 expires
Listed drug substance patent expiration.
Oct 17, 2027
in 1 yr 4 mo
Patent 10286036 expires
Listed method-of-use patent (U-3056) expiration.
Dec 07, 2037
in 11 yr 8 mo
Patent 11622991 expires
Listed method-of-use patent (U-3056) expiration.
Dec 07, 2037
in 11 yr 8 mo
Pharmaceutical detail
Active ingredient
VOCLOSPORIN
Strength
7.9MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 213716
Product number
001
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)
- NCENew chemical entity exclusivity (5 years)
Jan 22, 2026
5 mo ago
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7332472 | Oct 17, 2027 | in 1 yr 4 mo | SubstanceProductU-3056 |
| 10286036 | Dec 07, 2037 | in 11 yr 8 mo | U-3056 |
| 11622991 | Dec 07, 2037 | in 11 yr 8 mo | U-3056 |
