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CITANEST

NDA

PRILOCAINE HYDROCHLORIDE | N014763 | ASTRAZENECA LP

5 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
Lachman Consultant Services, Inc. - Citizen Petition FDA-2008-P-0528 · 5 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA determine whether Citanest (Prilocaine Hydrochloride) Injections in 1%, 2%, 3%, and 4% concentrations, approved under NDA 14-763 by Astra Zeneca, were voluntarily withdrawn from sale for reasons relat	505(q)	2008-10-01	Granted	—

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

Clinical Trials

55 trials from ClinicalTrials.gov, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Spinal Anesthesia Versus Combined Sciatic-femoral Nerve Block for Outpatient Knee Arthroscopy NCT02384915	Phase 4	Completed	ASST Gaetano Pini-CTO	100	2015-01 → 2015-05
Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma NCT02666534	Phase 1	Completed	Dong-A University	45	2012-01 → 2015-12
Comparison of Hyperbaric Prilocaine With Chloroprocaine for Intrathecal Anaesthesia in Day Case Knee Arthroscopy NCT03038958	Phase 4	Completed	Centre Hospitalier Universitaire Saint Pierre	80	2016-04 → 2016-07
Efficacy, Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment Premature Ejaculation NCT00556478	Phase 2/3	Completed	Plethora Solutions Ltd	256	2007-10 → 2009-10
Cutaneous Microcirculation and Diabetic Foot NCT01963559	N/A	Completed	Hospices Civils de Lyon	80	2012-04 → 2013-05
Pain Relief During Repair of Postpartum Perineal Tears NCT02883179	Phase 4	Completed	Assiut University	144	2016-10 → 2017-09
Efficacy of Topical Calcipotriol-assisted AFL-PDT in Actinic Keratosis NCT02976727	Phase 1	Completed	Dong-A University	48	2014-05 → 2015-08
Local Anesthetic Cream in Younger Patients Undergoing Lumbar Punctures NCT01516684	Phase 2	Completed	Wake Forest University Health Sciences	33	2012-05-14 → 2018-06-26
Efficacy of a Topical Anesthetic Containing Lidocaine and Prilocaine in Treatment With CO2 Fractional Laser NCT03366246	Phase 3	Completed	Galeno Desenvolvimento de Pesquisas Clínicas	120	2014-06-07 → 2014-07-25
Comparative Safety and Efficacy of Vaginal Misoprostol Versus Lidocaine-prilocaine Cream in Levonorgestrel IUD Insertion NCT04339348	Phase 3	Completed	Cairo University	210	2020-04-30 → 2021-03-01

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

API Supply Chain8 active DMFs2 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVPRILOCAINE USP

DMF 157722001

MOEHS IBERICA SLPRILOCAINE HYDROCHLORIDE

DMF 275862013

NORTEC QUIMICA SAPRILOCAINE

DMF 322832017

MOEHS IBERICA SLPRILOCAINE

DMF 328182018

SHANDONG CHENGHUI SHUANGDA PHARMACEUTICAL CO LTDPRILOCAINE HYDROCHLORIDE

DMF 347012020

SWATI SPENTOSE PRIVATE LTDPRILOCAINE USP

DMF 352602020

SWATI SPENTOSE PRIVATE LTDPRILOCAINE HYDROCHLORIDE USP

DMF 353342021

APEX HEALTHCARE LTDPRILOCAINE USP

DMF 419052025

WYCKOFF CHEMICAL CO INCInactivePRILOCAINE HYDROCHLORIDE USP

DMF 59481985

GUFIC BIOSCIENCES LTDInactivePRILOCAINE USP

DMF 252522011

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

Products (5)

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#003 — 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴