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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 petition requesting FDA evaluation of the suitability of a specific drug substance for use in pharmaceutical manufacturing and development, seeking agency guidance on whether the substance meets established standards for pharmaceutical use in approved or inv	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	Granted	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 The proposed product is identical in formulation, usage, and total drug amount to current	Other	2017-06-28	Withdrawn	Abbott Laboratories

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

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

APEX HEALTHCARE LTDBUPIVACAINE HYDROCHLORIDE USP

DMF 423242025

DISHMAN CARBOGEN AMCIS LTDBUPIVACAINE HYDROCHLORIDE

DMF 209592007

EXCELLA GMBH AND CO KGBUPIVACAINE HYDROCHLORIDE

DMF 211962007

MOEHS IBERICA SLBUPIVACAINE HYDROCHLORIDE

DMF 222282008

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.

Products (10)

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RLDAP

0 patents0 exclusivities▴