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MARCAINE HYDROCHLORIDE

NDA

BUPIVACAINE HYDROCHLORIDE | N016964 | HOSPIRA INC

10 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

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

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consultant Services, Inc. FDA-2026-P-8251 · 6 docket documents Lachman Consultant Services, Inc. filed a citizen petition requesting that the FDA determine the suitability of a proposed analytical method for use in regulatory applications related to drug products. The petition seeks FDA guidance on whether the method is appropriate for inclusion in an NDA, ANDA	Suitability	2026-07-28	Open	Lachman Consultant Services, Inc.
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2752 · 8 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Bupivacaine Hydrochloride Injection USP in 0.25% and 0.5% strengths suitable for submission as an ANDA in phar	Suitability	2024-06-10	GrantedNo FDA response document on docket	Hyman, Phelps & McNamara, P.C.
Citizen Petition from Abbott Laboratories FDA-1988-P-0375 · 7 docket documents Abbott Laboratories submitted a petition on June 7, 1988, requesting ANDA status for 0.125% Bupivacaine Hydrochloride Injection, USP in 100 mL PVC flexible containers containing 125 mg total drug per container. The proposed product is identical in formulation, usage, and total drug amount to current	Other	2017-06-28	WithdrawnUnverified summary	Abbott Laboratories

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

500 trials from ClinicalTrials.gov — 70 recruiting, 10 active, 406 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Transversus Abdominis Plane Block Compared to Local Anesthetic Wound Infiltration in Gynecologic Oncology Surgery NCT06213454	Phase 4	Active	University of Wisconsin, Madison	82	2024-03-26 → 2026-09
TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant NCT03737604	Phase 4	Active	University of California, Davis	200	2018-10-04 → 2026-09-12
Paracervical Injection and Opioid Use After Vaginal Hysterectomy for Prolapse NCT07213635	Phase 4	Active	University of North Carolina, Chapel Hill	56	2025-10-20 → 2026-12
Exparel Injection for Postoperative Orbital Pain NCT02381353	Phase 4	Active	Mayo Clinic	88	2015-02 → 2026-12
Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery NCT03214510	Phase 3	Active	M.D. Anderson Cancer Center	101	2017-10-04 → 2027-07-31
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control NCT03351348	Phase 3	Active	Memorial Sloan Kettering Cancer Center	165	2017-11-16 → 2027-11
A Study of TLC590 for Postsurgical Pain Following Bunionectomy NCT07222748	Phase 3	Active	TLC Biopharmaceuticals, Inc.	304	2025-11-17 → 2026-07
Intraprostatic Anesthesia During Transperineal Prostate Biopsy NCT07683182	N/A	Active	Marmara University	50	2025-11-01 → 2026-09-01
Intralipid® 20% for Reversal of Local Anesthetics NCT03968822	Phase 4	Active	Hospital for Special Surgery, New York	18	2019-07-26 → 2026-10
Effect of Addition of Steroids on Duration of Analgesia NCT04126824	Early Phase 1	Active	University of California, Los Angeles	28	2022-01-06 → 2027-08-02

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

VA Federal Supply Schedule

Government-negotiated contract prices | 40 NDCs (20 FSS, 20 Big4)

Lowest Price

$3.74

Highest Price

$166.33

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-0525-25MARCAINE HCL 0.5% INJ	$106.33	Big4	Pfizer Inc.	06/30/2029
00409-0525-25MARCAINE HCL 0.5% INJ	$127.14	FSS	Pfizer Inc.	06/30/2029
00409-1530-25MARCAINE HCL 0.5% (PF) INJ	$71.46	Big4	Pfizer Inc.	06/30/2029
00409-1530-25MARCAINE HCL 0.5% (PF) INJ	$111.31	FSS	Pfizer Inc.	06/30/2029
00409-1559-10MARCAINE HCL 0.25% INJ SV	$29.11	Big4	Pfizer Inc.	06/30/2029
00409-1559-10MARCAINE HCL 0.25% INJ SV	$33.07	FSS	Pfizer Inc.	06/30/2029

Showing 6 of 40 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain6 active DMFs1 inactive

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

CAMBREX KARLSKOGA ABBUPIVACAINE HYDROCHLORIDE

DMF 59841985

SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRLBUPIVACAINE HYDROCHLORIDE

DMF 64951986

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE HYDROCHLORIDE

DMF 209592007

EXCELLA GMBH AND CO KGBUPIVACAINE HYDROCHLORIDE

DMF 211962007

MOEHS IBERICA SLBUPIVACAINE HYDROCHLORIDE

DMF 222282008

APEX HEALTHCARE LTDBUPIVACAINE HYDROCHLORIDE USP

DMF 423242025

FRESENIUS KABI ONCOLOGY LTDInactiveBUPIVACAINE HYDROCHLORIDE

DMF 266492012

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Aug 28, 2020	SUPPL -82	View Letter (PDF)
Nov 6, 2018	SUPPL -77	View Letter (PDF)
Feb 1, 2012	SUPPL -70	View Letter (PDF)
Feb 25, 2010	SUPPL -69	View Letter (PDF)
Nov 1, 2005	SUPPL -61	View Letter (PDF)

Source: Drugs@FDA application documents.

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RLDAP

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