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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

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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$35.18

Highest Price

$48.65

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00409-1761-10MARCAINE 0.75%/DEXTROSE 8.25% INJ 2ML AMP	$35.18	Big4	Pfizer Inc.	06/30/2029
00409-1761-10MARCAINE 0.75%/DEXTROSE 8.25% INJ 2ML AMP	$48.65	FSS	Pfizer Inc.	06/30/2029

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

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Marcaine — Bupivacaine HCl/PF (2024)

Total Spending

$301.68

Total Claims

Beneficiaries

Avg Cost/Unit

$0.53

Spending Trend

$75.10(2019)→$262.85(2021)→$160.98(2022)→$694.35(2023)→$301.68(2024)

YoY Change:+3.3%

5yr CAGR:+6.5%

Marcaine — Bupivacaine HCl (2024)

Total Spending

$262.16

Total Claims

Beneficiaries

Avg Cost/Unit

$0.16

Spending Trend

$382.46(2021)→$297.32(2023)→$262.16(2024)

YoY Change:+10.1%

5yr CAGR:+9.2%

Source: CMS Medicare Part D Spending by Drug (2024). 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.