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CHIROCAINE

NDA

LEVOBUPIVACAINE HYDROCHLORIDE | N020997 | PURDUE PHARMA LP

3 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 from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2022-P-3293 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether CHIROCAINE (Levobupivacaine Injection in 2.5, 5, and 7.5 mg/mL formulations, NDA 20997) held by Purdue Pharma LP was voluntarily withdrawn for safety or efficacy reasons, as the petitioner believes the di	505(q)	2022-12-21	Granted	Lachman Consultant Services, Inc.

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

Clinical Trials

133 trials from ClinicalTrials.gov, 2 active, 87 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia NCT03121261	Phase 4	Active	University Hospital Dubrava	60	2017-05-01 → 2028-10
Levobupivacaine and Lidocaine for Paravertebral Block Causes Greater Hemodynamic Oscillations Than Levobupivacaine NCT02004834	Phase 4	Active	University Hospital Dubrava	80	2013-08 → 2029-10
Levobupivacaine vs Levobupivacaine + Dexmedetomidine Infiltration for Post-tonsillectomy Analgesia and Laryngospasm in Pediatric Patients NCT04113720	Phase 1/2	Completed	Assiut University	90	2019-11-15 → 2020-11-30
Decision Support for Intraoperative Low Blood Pressure NCT02726620	N/A	Completed	Vanderbilt University Medical Center	22,435	2017-01-05 → 2018-12-29
Comparison of Intratechal Levobupivacaine and Adding With Sufetanil and Fentanyl in Ceserean Section NCT02430090	Phase 2	Completed	Ankara City Hospital Bilkent	45	2006-11 → 2007-03
Local Wound Infiltration With 0.5% Levobupivacaine for Postoperative Pain After Laparoscopic Colorectal Surgery.NCT03433014	N/A	Completed	Mahidol University	30	2018-03-31 → 2020-12-30
The Effect of Retrobulbar Block for Eye Surgery on Brain Oxygenation and Cognitive Functions in Elderly Patients NCT03189329	Phase 4	Completed	Cengiz KAYA	66	2015-01 → 2016-01
Pain Reduction After Cholecystectomy NCT01199406	Phase 4	Completed	Meander Medical Center	80	2009-07 → 2010-01
The Effects of Scalp Block With Bupivacaine Versus Levobupivacaine NCT02497040	Phase 4	Completed	Uludag University	90	2008-03 → 2009-04
Comparison of the Analgesic Effect of Different Local Anesthetics in Interscalene Nerve Block for Shoulder Surgery NCT02691442	Phase 4	Completed	University Hospital, Antwerp	30	2010-12 → 2016-04

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

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

EDMOND PHARMA SRLLEVOBUPIVACAINE HYDROCHLORIDE

DMF 388582023

DISHMAN CARBOGEN AMCIS LTDInactiveLEVOBUPIVACAINE

DMF 339822019

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 5, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 2.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 5, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 5, 1999

#003 — EQ 7.5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Aug 5, 1999