FDA Orange Book · active-ingredient family
Bupivacaine hydrochloride; epinephrine bitartrate
Bupivacaine hydrochloride; epinephrine bitartrate is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SENSORCAINE · NDA 018304
3
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SENSORCAINERLD×2 | FRESENIUS KABI USA | NDA 018304 | AP | Sep 02, 1983 | |
| BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINERLD | HOSPIRA | NDA 022046 | — | Jul 13, 1983 | |
| MARCAINE HYDROCHLORIDE W/ EPINEPHRINERLD×5 | HOSPIRA | NDA 016964 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VIVACAINE | SEPTODONT | ANDA 077250 | — | Sep 27, 2006 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070966 | AP | Oct 13, 1987 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070967 | AP | Oct 13, 1987 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070968 | AP | Oct 13, 1987 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Bupivacaine hydrochloride; epinephrine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
