FDA Orange Book · active-ingredient family
Chloroprocaine hydrochloride
Chloroprocaine hydrochloride is approved as 3 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IHEEZO · NDA 216227
3
Brand (NDA)
3
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · gel, injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IHEEZORLD | HARROW EYE | NDA 216227 | — | Sep 27, 2022 | |
| CLOROTEKALRLD | B BRAUN MEDICAL | NDA 208791 | — | Sep 26, 2017 | |
| NESACAINERLD×6 | FRESENIUS KABI USA | NDA 009435 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (3)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLOROPROCAINE HYDROCHLORIDE×2 | HIKMA | ANDA 040273 | AP | Sep 09, 1998 | |
| CHLOROPROCAINE HYDROCHLORIDE | HOSPIRA | ANDA 087447 | — | Apr 16, 1982 | |
| CHLOROPROCAINE HYDROCHLORIDE | HOSPIRA | ANDA 087446 | — | Apr 16, 1982 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8969412 | Sep 05, 2026 | in 3 mo | ProductU-2609 |
| 9504666 | Dec 11, 2033 | in 7 yr 7 mo | Product |
| 10792271 | Sep 15, 2038 | in 12 yr 5 mo | ProductU-3457 |
| 11969403 | May 14, 2039 | in 13 yr 1 mo | Product |
Chloroprocaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
