FDA Orange Book · active-ingredient family
Chloroprocaine hydrochloride
Chloroprocaine hydrochloride: 3 brands, 3 generics; first approved Apr 16, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 3 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
3
Listed patents
4
Next patent expiry
Sep 05, 2026
in 12 d
Brand (NDA) products
Originator applications
- HARROW EYENDA 2162272022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3% GEL OPHTHALMIC Rx — - CLOROTEKALRLDB BRAUN MEDICALNDA 2087912017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG/5ML (10MG/ML) SOLUTION INTRATHECAL Discontinued — - NESACAINERLDFRESENIUS KABI USANDA 009435—6 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1% INJECTABLE INJECTION Discontinued — 2% INJECTABLE INJECTION Rx AP 2% INJECTABLE INJECTION Discontinued — 3% INJECTABLE INJECTION Discontinued — 2% INJECTABLE INJECTION Rx AP 3% INJECTABLE INJECTION Rx AP
Generic (ANDA) products (3)
Abbreviated applications
- CHLOROPROCAINE HYDROCHLORIDEHIKMAANDA 04027319982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% INJECTABLE INJECTION Rx AP 3% INJECTABLE INJECTION Rx AP - CHLOROPROCAINE HYDROCHLORIDEHOSPIRAANDA 0874471982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2% INJECTABLE INJECTION Discontinued — - CHLOROPROCAINE HYDROCHLORIDEHOSPIRAANDA 0874461982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3% INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8969412 | in 12 d | ProductU-2609 | |
| 9504666 | in 7 yr 5 mo | Product | |
| 10792271 | in 12 yr 3 mo | ProductU-3457 | |
| 11969403 | in 12 yr 11 mo | Product |
Approval history
FDA approval span
First approval
45 yr ago
Most recent approval
4 yr ago
Approvals span 1982–2022 across 6 FDA applications.
Brand (NDA) 350%
Generic (ANDA) 350%
Chloroprocaine 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 BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
