Orange Book product · Brand (NDA)
CYKLX
ARTICAINE HYDROCHLORIDE
At a glance
Aug 15, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 15, 2025
10 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 15, 2028
in 2 yr 2 mo
Patent 11096922 expires
Listed drug product patent expiration.
Mar 27, 2039
in 12 yr 11 mo
Patent 11826347 expires
Listed drug product patent expiration.
Mar 27, 2039
in 12 yr 11 mo
Patent 12403126 expires
Listed drug product patent expiration.
Mar 27, 2039
in 12 yr 11 mo
Pharmaceutical detail
Active ingredient
ARTICAINE HYDROCHLORIDE
Strength
EQ 8% BASE
Dosage form
SOLUTION/DROPS
Route
OPHTHALMIC
TE code
Not listed
Application
NDA 218643
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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)
- NPNew product exclusivity (3 years)
Aug 15, 2028
in 2 yr 2 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11096922 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4423 |
| 11826347 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4423 |
| 12403126 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4422 |
