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MARCAINE

NDA

BUPIVACAINE HYDROCHLORIDE | N018692 | HOSPIRA INC

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Marcaine (2023)

Total Spending

$694.35

Total Claims

Beneficiaries

Avg Cost/Unit

$0.51

Spending Trend

$75.10(2019)→$382.46(2021)→$262.85(2021)→$160.98(2022)→$297.32(2023)→$694.35(2023)

YoY Change:-33.6%

5yr CAGR:+20.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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
Sep 29, 2022	SUPPL -24	View Letter (PDF)
Nov 8, 2018	SUPPL -20	View Letter (PDF)
Feb 1, 2012	SUPPL -15	View Letter (PDF)
Feb 25, 2010	SUPPL -14	View Letter (PDF)
Jun 22, 2003	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.75%

RLDAP

0 patents0 exclusivities▴

INJECTABLE;SPINAL | Approved: May 4, 1984

No patent or exclusivity listings for this strength.