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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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-2752 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	Open	Hyman

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

Clinical Trials

32 trials from ClinicalTrials.gov — 26 recruiting, 2 active, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ESP/PIF for Sternotomy NCT04985500	Early Phase 1	Active	Icahn School of Medicine at Mount Sinai	225	2021-07-09 → 2026-12-31
Comparing Two Nerve Block Methods for Pain Relief in Laparoscopic Hernia Surgery NCT07676123	N/A	Active	Ankara University	66	2025-06-26 → 2026-06-26
Compined Lumber Longissimus Plane Block and Multifidus Longissimus Plane Block Versus Infiltration Field Block in Lumber Spine Surgery NCT07681648	Phase 4	By Invitation	Aswan University	50	2026-06-30 → 2026-12-20
Bupivacaine Hydrochloride for Pain Control in Cutaneous Surgery NCT04260854	Phase 1	By Invitation	Northwestern University	100	2024-01-24 → 2028-12
Comparative Evaluation of Diaphragmatic Function Following Interscalene, Anterior Suprascapular, and Costoclavicular Nerve Blocks in Shoulder Surgery NCT07671352	Phase 4	Not Yet Recruiting	Menoufia University	75	2026-06-25 → 2027-01-01
PENG+LFCN Block vs QIPB for Total Hip Arthroplasty NCT07667231	N/A	Not Yet Recruiting	Antalya City Hospital	60	2026-11-15 → 2027-09-15
Lateral Versus Subcostal TAP Block for Drain-Site Analgesia in Laparoscopic Cholecystectomy NCT07661576	N/A	Not Yet Recruiting	Turgut Ozal University	88	2026-06-15 → 2027-05-15
Comparison Between Quadro-iliac Plane Block (QIPB) and Supra-Inguinal Fascia Iliaca Compartment Block (S-FICB) for Total Hip Arthroplasty NCT07667218	N/A	Not Yet Recruiting	Antalya City Hospital	60	2026-11-15 → 2027-09-15
ESP Blocks for Posterior Spinal Fusion NCT07228039	Phase 4	Not Yet Recruiting	Duke University	75	2026-07 → 2028-01
Influence of Superficial Parasternal Intercostal Plane Block on Internal Thoracic Artery Caliber to Facilitate Surgical Harvesting in CABG NCT07663435	Phase 3	Not Yet Recruiting	Ain Shams University	50	2026-07 → 2026-12-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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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