FDA Orange Book · active-ingredient family
Articaine hydrochloride
Articaine hydrochloride: 1 brand, 0 generics; first approved Aug 15, 2025; on patent until Mar 27, 2039.
On patent1 exclusivity periodHas discontinued products
Generic status & protection
Protected until Mar 27, 2039 (earliest listed patent expiry).
Earliest patent expiry Mar 27, 2039Latest exclusivity ends Aug 15, 2028
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
3
Next patent expiry
Mar 27, 2039
in 12 yr 11 mo
Originator applications
Brand (NDA) products
CYKLXRLDTHEA PHARMANDA 2186432025
CYKLXRLD
THEA PHARMANDA 2186432025
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| EQ 8% BASE | SOLUTION/DROPS | OPHTHALMIC | Discontinued | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Aug 15, 2028
in 2 yr 1 mo
Orange Book patent file
Listed patents
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403126 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4422 |
| 11826347 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4423 |
| 11096922 | Mar 27, 2039 | in 12 yr 11 mo | ProductU-4423 |
FDA approval span
Approval history
First approval
Aug 15, 2025
11 mo ago
Most recent approval
Aug 15, 2025
11 mo ago
All 1 application were approved in 2025.
Brand (NDA) 1100%
Generic (ANDA) 00%
Articaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
