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NDA

BUPIVACAINE | N022496 | PACIRA PHARMACEUTICALS INC

2 strengths21 unique patents1 unique exclusivity

Patent Timeline

21 unique patents, 1 exclusivity by expiration date

Active (21)TodayExclusivity

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Today

Jan. 22, 2041

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Jan. 22, 2041

Jan. 22, 2041

Jan. 22, 2041

Jan. 22, 2041

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Feb. 2, 2043

Jan. 22, 2041

Mar. 17, 2042

Jan. 22, 2041

Jan. 22, 2041

Jul. 2, 2044

Feb. 2, 2043

Jul. 2, 2044

Jan. 22, 2041

Jul. 2, 2044

Jul. 2, 2044

I-929

Nov. 9, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/019,692Ex PartePending

Patent: 11033495Filed: 2024-10-03

MANUFACTURING OF BUPIVACAINE MULTIVESICULAR LIPOSOMES

Recent Events

2025-05-28RXLITSRLitigation Search Conducted

2024-10-03RXRLFLitigation Found

2024-10-03RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

4 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
PACIRA PHARMACEUTICALS, INC. et al v. QILU PHARMACEUTICAL (HAINAN) CO., LTD., et al 2:2025cv06742 9 patentsANDA 220830bupivacaine liposome injectable suspension	E.D. Pa.	2025-12-01	Terminated 2026-02-17	—
Pacira Pharmaceuticals, Inc. et al v. The WhiteOak Group, Inc. et al 1:2025cv01445 9 patentsANDA 220735, 220830bupivacaine liposome injectable suspension	D. Del.	2025-11-26	Active	—
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).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

8 letters from Drugs@FDA

Date	Submission	Document
Nov 29, 2023	SUPPL -51	View Letter (PDF)
Nov 14, 2023	SUPPL -44	View Letter (PDF)
Mar 24, 2021	SUPPL -35	View Letter (PDF)
Jan 7, 2021	SUPPL -36	View Letter (PDF)
Nov 9, 2018	SUPPL -30	View Letter (PDF)
Dec 14, 2015	SUPPL -19	View Letter (PDF)
Dec 9, 2014	SUPPL -5	View Letter (PDF)
Oct 31, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 133MG/10ML (13.3MG/ML)

RLD

21 patents1 exclusivity▴

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Oct 28, 2011

Patents (21)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11033495	Jan 22, 2041	—	—	Yes		—
11179336	Jan 22, 2041	—	—	Yes		—
11278494	Jan 22, 2041	—	—	Yes		—
11304904	Jan 22, 2041	—	—	Yes		—
11311486	Jan 22, 2041	—	—	Yes		—
11357727	Jan 22, 2041	—	—	Yes		—
11426348	Jan 22, 2041	—	—	Yes		—
11452691	Jan 22, 2041	—	—	Yes		—
11819574	Jan 22, 2041	—	—	Yes		—
11819575	Jan 22, 2041	—	—	Yes		—
11918565	Feb 2, 2043	—	—	—		—
11925706	Jan 22, 2041	—	—	Yes		—
11931459	Mar 17, 2042	—	—	—		—
12144890	Jan 22, 2041	—	—	Yes		—
12151024	Jan 22, 2041	—	—	Yes		—
12156940	Jul 2, 2044	—	—	Yes	—	—
12226610	Feb 2, 2043	—	—	—		—
12251468	Jul 2, 2044	—	—	Yes		—
12296047	Jan 22, 2041	—	—	Yes		—
12318483	Jul 2, 2044	—	—	—		—
12370142	Jul 2, 2044	—	—	Yes		—

Exclusivities (1)

Code	Date	Status
I-929	Nov 9, 2026	< 1 year

#002 — 266MG/20ML (13.3MG/ML)

RLD

21 patents1 exclusivity▾

INJECTABLE, LIPOSOMAL;INJECTION | Approved: Oct 28, 2011