FDA Orange Book · active-ingredient family
Bupivacaine hydrochloride
Bupivacaine hydrochloride is approved as 6 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:XARACOLL · NDA 209511
6
Brand (NDA)
29
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · implant, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XARACOLLRLD | INNOCOLL PHARMS | NDA 209511 | — | Aug 28, 2020 | |
| MARCAINERLD | HOSPIRA | NDA 018692 | AP | May 04, 1984 | |
| MARCAINE HYDROCHLORIDERLD×5 | HOSPIRA | NDA 016964 | AP | Approved Prior to Jan 1, 1982 | |
| SENSORCAINERLD×3 | FRESENIUS KABI USA | NDA 018304 | AP | Approved Prior to Jan 1, 1982 | |
| BUPIVACAINE HYDROCHLORIDE KIT×3 | HOSPIRA | NDA 019978 | — | Sep 03, 1992 | |
| BUPIVACAINE HYDROCHLORIDE×3 | HOSPIRA | NDA 018053 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (29)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BUPIVACAINE HYDROCHLORIDE×3 | ANTHEA PHARMA | ANDA 220493 | AP | Apr 22, 2026 | |
| BUPIVACAINE HYDROCHLORIDE×3 | ASPIRO | ANDA 217821 | AP | Mar 27, 2024 | |
| BUPIVACAINE HYDROCHLORIDE×3 | MEITHEAL | ANDA 216040 | AP | Dec 27, 2023 | |
| BUPIVACAINE HYDROCHLORIDE×2 | SOMERSET | ANDA 217792 | AP | Nov 20, 2023 | |
| BUPIVACAINE HYDROCHLORIDE×2 | MEITHEAL | ANDA 216039 | AP | Jun 23, 2023 | |
| BUPIVACAINE HYDROCHLORIDE×2 | HIKMA PHARMS | ANDA 205141 | AP | Feb 11, 2021 | |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE×3 | HIKMA PHARMS | ANDA 204842 | AP | Feb 11, 2021 | |
| BUPIVACAINE HYDROCHLORIDE | HUONS | ANDA 212822 | AP | Dec 30, 2019 | |
| BUPIVACAINE HYDROCHLORIDE | B BRAUN MEDICAL | ANDA 209087 | AP | Apr 02, 2019 | |
| BUPIVACAINE HYDROCHLORIDE | CIVICA | ANDA 211096 | — | Feb 19, 2019 | |
| BUPIVACAINE HYDROCHLORIDE | BAXTER HLTHCARE CORP | ANDA 207266 | — | Jul 25, 2016 | |
| BUPIVACAINE HYDROCHLORIDE×2 | EUGIA PHARMA | ANDA 207183 | AP | May 13, 2016 | |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE×3 | EUGIA PHARMA | ANDA 203895 | AP | Nov 05, 2013 | |
| BUPIVACAINE HYDROCHLORIDE×2 | ONESOURCE SPECIALTY | ANDA 091503 | AP | Oct 18, 2011 | |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE×3 | ONESOURCE SPECIALTY | ANDA 091487 | AP | Oct 18, 2011 | |
| BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE×3 | INTL MEDICATED | ANDA 076012 | — | Jan 09, 2002 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 071810 | AP | Dec 11, 1987 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 071202 | — | Apr 15, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070586 | — | Mar 03, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070597 | AP | Mar 03, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070609 | AP | Mar 03, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070585 | AP | Mar 03, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070587 | — | Mar 03, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070583 | AP | Feb 17, 1987 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070590 | AP | Feb 17, 1987 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070552 | AP | May 21, 1986 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070553 | AP | May 21, 1986 | |
| SENSORCAINE | FRESENIUS KABI USA | ANDA 070554 | AP | May 21, 1986 | |
| BUPIVACAINE HYDROCHLORIDE | HOSPIRA | ANDA 070584 | AP | Feb 17, 1986 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE47826 | May 20, 2029 | in 3 yr | U-2949 |
| 11746141 | Jan 09, 2033 | in 6 yr 8 mo | Product |
Bupivacaine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
