Orange Book product · Brand (NDA)
ICOTYDE
ICOTROKINRA HYDROCHLORIDE
At a glance
Mar 17, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 17, 2026
3 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Mar 17, 2031
in 4 yr 10 mo
Patent 12552836 expires
Listed drug substance patent expiration.
Jul 12, 2039
in 13 yr 3 mo
Patent 11845808 expires
Listed drug substance patent expiration.
Jan 14, 2041
in 14 yr 9 mo
Patent 11939361 expires
Listed drug product patent expiration.
Nov 19, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
ICOTROKINRA HYDROCHLORIDE
Strength
EQ 200MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 220149
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)
Mar 17, 2031
in 4 yr 10 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12552836 | Jul 12, 2039 | in 13 yr 3 mo | SubstanceProduct |
| 11845808 | Jan 14, 2041 | in 14 yr 9 mo | SubstanceU-4447 |
| 11939361 | Nov 19, 2041 | in 15 yr 8 mo | ProductU-4447 |

