Orange Book product · Brand (NDA)
KLISYRI
TIRBANIBULIN
At a glance
Dec 14, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 2020
5 yr 7 mo ago
Today
Exclusivity ends · D-192
New indication / change exclusivity (3 years)
Jun 07, 2027
in 1 yr
Patent 10323001 expires
Listed drug product patent expiration.
Dec 28, 2027
in 1 yr 7 mo
Patent 7851470 expires
Listed drug substance patent expiration.
Feb 02, 2029
in 2 yr 8 mo
Patent 7300931 expires
Listed drug substance patent expiration.
Dec 28, 2030
in 4 yr 7 mo
Patent 10617693 expires
Listed method-of-use patent (U-3015) expiration.
Mar 12, 2038
in 11 yr 11 mo
Patent 11497750 expires
Listed method-of-use patent (U-3015) expiration.
Mar 12, 2038
in 11 yr 11 mo
Patent 10669236 expires
Listed drug substance patent expiration.
Sep 07, 2038
in 12 yr 5 mo
Pharmaceutical detail
Active ingredient
TIRBANIBULIN
Strength
1%
Dosage form
OINTMENT
Route
TOPICAL
TE code
Not listed
Application
NDA 213189
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)
- D-192New indication / change exclusivity (3 years)
Jun 07, 2027
in 1 yr
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10323001 | Dec 28, 2027 | in 1 yr 7 mo | Product |
| 7851470 | Feb 02, 2029 | in 2 yr 8 mo | SubstanceProductU-3015 |
| 7300931 | Dec 28, 2030 | in 4 yr 7 mo | SubstanceProduct |
| 10617693 | Mar 12, 2038 | in 11 yr 11 mo | U-3015 |
| 11497750 | Mar 12, 2038 | in 11 yr 11 mo | U-3015 |
| 10669236 | Sep 07, 2038 | in 12 yr 5 mo | SubstanceProduct |
