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BUPIVACAINE LIPOSOME

ANDA

BUPIVACAINE | A214348 | JIANGSU HENGRUI PHARMACEUTICALS CO LTD

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
PACIRA PHARMACEUTICALS, INC. et al v. EVENUS PHARMACEUTICALS LABORATORIES INC. et al 2:2023cv02367 3 patentsANDA 214348bupivacaine	D.N.J.	2023-04-28	Terminated 2025-04-15	—
PACIRA PHARMACEUTICALS, INC. et al v. EVENUS PHARMACEUTICALS LABORATORIES INC. et al 2:2021cv19829 1 patentANDA 214348bupivacaine	D.N.J.	2021-11-08	Terminated 2024-08-27	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain9 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SABUPIVACAINE HCL

DMF 29111977

SIEGFRIED EVIONNAZ SABUPIVACAINE BASE

DMF 119381996

CAMBREX KARLSKOGA ABBUPIVACAINE BASE

DMF 191772006

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE

DMF 323692017

NORTEC QUIMICA SABUPIVACAINE

DMF 332852018

JIANGSU HENGRUI PHARMACEUTICALS CO LTDBUPIVACAINE BASE

DMF 349002020

MSN LIFE SCIENCES PRIVATE LTDBUPIVACAINE

DMF 353222020

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDBUPIVACAINE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 402732024

HAICHANG BIOTECH CO LTDBUPIVACAINE

DMF 411352025

EXCELLA GMBHInactiveBUPIVACAINE (S) HYDROCHLORIDE

DMF 250902011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 2, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 133MG/10ML (13.3MG/ML)

0 patents0 exclusivities▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Jul 1, 2024

No patent or exclusivity listings for this strength.

#002 — 266MG/20ML (13.3MG/ML)

0 patents0 exclusivities▾

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Jul 1, 2024