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Lidocaine - Generic Drug Details

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What are the generic drug sources for lidocaine and what is the scope of lidocaine freedom to operate?

Lidocaine is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Acp Nimble, Aleor Dermaceuticals, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Fougera Pharms Inc, Glenmark Pharms Ltd, Riconpharma Llc, Septodont Inc, Strides Pharma, Taro, Teligent Pharma Inc, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Teikoku Pharma Usa, Scilex Pharms Inc, Akorn, Abbott, Abraxis Pharm, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Gd Searle Llc, Hospira, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Fresenius Kabi Usa, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma Inc, Sagent Pharms, Watson Labs Inc, Oak Pharms, Hi Tech Pharma, Wockhardt Bio Ag, Actavis Mid Atlantic, Lannett Co Inc, Kendall Il, Paco, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Tolmar, Taro Pharms, and Galen Specialty, and is included in one hundred and thirty-six NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lidocaine has ten patent family members in seven countries.

There are twenty-nine drug master file entries for lidocaine. Forty-four suppliers are listed for this compound.

Summary for lidocaine

International Patents:	10
US Patents:	9
Tradenames:	45
Applicants:	63
NDAs:	136
Drug Master File Entries:	29
Suppliers / Packagers:	44
Bulk Api Vendors:	103
Clinical Trials:	1,149
Patent Applications:	8,542
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for lidocaine
Drug Sales Revenues:	Drug sales revenues for lidocaine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for lidocaine
DailyMed Link:	lidocaine at DailyMed

Pharmacology for lidocaine

Drug Class	Amide Local Anesthetic Antiarrhythmic
Physiological Effect	Local Anesthesia

Medical Subject Heading (MeSH) Categories for lidocaine

Anesthetics, Local

Anti-Arrhythmia Agents

Voltage-Gated Sodium Channel Blockers

Synonyms for lidocaine

.alpha.-(Diethylamino)-2,6-acetoxylidide

.alpha.-Diethylamino-2,6-acetoxylidide

.alpha.-Diethylamino-2,6-dimethylacetanilide

.alpha.-Diethylaminoaceto-2,6-xylidide

.omega.-Diethylamino-2,6-dimethylacetanilide

(2,6-dimethylphenyl)carbamoylmethyl-diethyl-azanium

137-58-6

2-(Diethylamino)-2',6'-acetoxylidide

2-(Diethylamino)-2'',6''-acetoxylidide

2-(Diethylamino)-N-(2,6-dimethylphenyl)-acetamide

2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide

2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide #

2-(Diethylamino)-N-(2,6-Dimethylphenyl)ethanamide

2-Diethylamino-N-(2,6-dimethyl-phenyl)-acetamide

2-Diethylamino-N-(2,6-dimethylphenyl)acetamide

2', 2-(diethylamino)-

2',6'-Acetoxylidide, 2-(diethylamino)-

4-12-00-02538 (Beilstein Handbook Reference)

6108-05-0 (mono-hydrochloride, mono-hydrate)

73-78-9 (mono-hydrochloride)

91484-71-8

98PI200987

A18187

AB00053581

AB00053581_29

AB00053581_30

AB00053581-27

AB00053581-28

AB2000065

AC-10282

AC1L1GGQ

AC1Q2Z7J

Acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-

After Burn Double Strength Gel

After Burn Double Strength Spray

After Burn Gel

After Burn Spray

AJ-08416

AKOS001026768

alfa-Dietilamino-2,6-dimetilacetanilide

alfa-Dietilamino-2,6-dimetilacetanilide [Italian]

alpha-Diethylamino-2,6-dimethylacetanilide

Alphacaine

Alphacaine;Xylocaine;lignocaine

AN-23138

Anestacon

Anestacon Jelly

ANW-42187

ARONIS23855

AS-13718

BBL005525

BCP09081

BDBM50017662

BIDD:GT0342

Bio1_000379

Bio1_000868

Bio1_001357

Bio2_000079

Bio2_000559

BPBio1_000197

BRD-K52662033-001-02-6

BRD-K52662033-003-05-5

BRD-K52662033-003-14-7

BRN 2215784

BSPBio_000179

BSPBio_001359

BSPBio_003004

C07073

C14H22N2O

Cappicaine

CAS-137-58-6

CAS-73-78-9

CCG-100824

CDS1_000283

CHEBI:6456

CHEMBL79

Cito optadren

CPD000058189

CS-2070

CTK3J2126

Cuivasil

D00358

Dalcaine

DB00281

Dentipatch

Dentipatch (TN)

DermaFlex

Diethylaminoacet-2,6-xylidide

Diethylaminoaceto-2,6-xylidide

Dilocaine

DivK1c_000174

DivK1c_001323

DSSTox_CID_25166

DSSTox_GSID_45166

DSSTox_RID_80716

DTXSID1045166

Duncaine

EINECS 205-302-8

ELA-Max

EMBOLEX

Epitope ID:116205

Esracaine

FT-0082378

FT-0600570

Gravocain

GTPL2623

HMS1791D21

HMS1989D21

HMS2051C21

HMS2089E15

HMS2235O14

HMS3371J04

HMS3393C21

HMS3428O07

HMS3651G09

HMS548M19

HSDB 3350

HY-B0185

I01-2704

IDI1_000174

IDI1_033829

Isicaina

Isicaine

J10173

Jetocaine

K-4450

KBio1_000174

KBio2_000079

KBio2_001598

KBio2_002647

KBio2_004166

KBio2_005215

KBio2_006734

KBio3_000157

KBio3_000158

KBio3_002224

KBioGR_000079

KBioGR_000599

KBioSS_000079

KBioSS_001598

KS-000046GY

L-Caine

L0156

Lanabiotic

Leostesin

Lida-Mantle

Lidaform HC (Salt/Mix)

Lidamantle HC (Salt/Mix)

Lidocaina

Lidocaina [INN-Spanish]

LIDOCAINE (73-58-6 (MONOHYDROCHLORIDE); 6108-05-0 (MONOHYDROCHLORIDE MONOHYDRATE))

Lidocaine (Alphacaine)

Lidocaine (JP17/USP/INN)

Lidocaine (VAN)

Lidocaine [USAN:INN:JAN]

Lidocaine [USP:INN:BAN:JAN]

Lidocaine 1.0 mg/ml in Methanol

Lidocaine Base

Lidocaine Carbonate

Lidocaine Hydrocarbonate

Lidocaine Monohydrochloride

Lidocaine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Lidocaine, 97.5%

Lidocaine, analytical standard

Lidocaine, British Pharmacopoeia (BP) Reference Standard

Lidocaine, European Pharmacopoeia (EP) Reference Standard

Lidocaine, Pharmaceutical Secondary Standard; Certified Reference Material

Lidocaine, powder

Lidocaine, United States Pharmacopeia (USP) Reference Standard

Lidocaine(Alphacaine)

Lidocainum

Lidocainum [INN-Latin]

Lidocaton

Lidoderm

Lidoject-1

Lidoject-2

LIDOPEN

Lidothesin (Salt/Mix)

Lignocaine

Lignocaine base

Lignocainum

Lopac-L-5647

Lopac0_000669

LQZ

LS-805

M620

Maricaine

Maybridge1_002571

MCULE-9294700940

MFCD00026733

MLS000069724

MLS000758263

MLS001074177

MLS001423964

MolPort-001-783-478

N-(2,6-dimethylphenyl)-N(2),N(2)-diethylglycinamide

N-(2,6-dimethylphenyl)-N~2~,N~2~-diethylglycinamide

N-(2,6-Dimethylphenyl)-N2,N2-diethylglycinamide

N~1~-(2,6-dimethylphenyl)-N~2~,N~2~-diethylglycinamide

N1-(2,6-dimethylphenyl)-2-(diethylamino)acetamide

N1-(2,6-dimethylphenyl)-N2,N2-diethylglycinamide

NC00074

NCGC00015611-01

NCGC00015611-02

NCGC00015611-03

NCGC00015611-04

NCGC00015611-05

NCGC00015611-06

NCGC00015611-07

NCGC00015611-08

NCGC00015611-09

NCGC00015611-10

NCGC00015611-11

NCGC00015611-12

NCGC00015611-13

NCGC00015611-14

NCGC00015611-15

NCGC00015611-16

NCGC00015611-18

NCGC00022176-05

NCGC00022176-06

NCGC00022176-07

NCGC00022176-08

NCGC00022176-09

Neosporin Plus (Salt/Mix)

NINDS_000174

NNJVILVZKWQKPM-UHFFFAOYSA-N

Norwood Sunburn Spray

NSC 40030

NSC-40030

NSC40030

Octocaine

Octocaine-100

Octocaine-50

Opera_ID_385

Prestwick0_000050

Prestwick1_000050

Prestwick2_000050

Prestwick3_000050

Remicaine

Rocephin Kit

RTR-031283

Rucaina

s1357

SAM001247018

SB19118

SBB080556

SBI-0050648.P004

SC-19460

SCHEMBL15689

SCHEMBL17967359

SMR000058189

Solarcaine aloe extra burn relief cream

Solcain

SPBio_001525

SPBio_002100

Spectrum_001118

Spectrum2_001343

Spectrum3_001392

Spectrum4_000070

Spectrum5_001549

ST023341

STK552033

SW196598-4

Tox21_110183

Tox21_110183_1

TR-031283

UNII-98PI200987

Versatis

W-108233

WLN: 2N2 & 1VMR B1 F1

Xilina

Xilocaina

Xilocaina [Italian]

Xllina

Xycaine

Xylestesin

Xylesthesin

Xyline

Xylocain

Xylocaine

Xylocaine (TN)

Xylocaine 5% Spinal

Xylocaine CO2

Xylocaine Dental Ointment

Xylocaine Endotracheal

Xylocaine Test Dose

Xylocaine Viscous

Xylocaine-Mpf

Xylocaine-Mpf with Glucose

Xylocard

Xylocitin

Xyloneural (free base)

Xyloneural (Salt/Mix)

Xylotox

Z55135799

Zilactin-L

ZINC20237

Zingo

Zingo (Salt/Mix)

Ztilido

ZTlido

US Patents and Regulatory Information for lidocaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	018967-003	Mar 30, 1984		DISCN	No	No
Acp Nimble	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	JELLY;TOPICAL	081318-001	Apr 29, 1993		DISCN	No	No
Alkem Labs Ltd	LIDOCAINE	lidocaine	OINTMENT;TOPICAL	207810-001	Mar 10, 2017	AT	RX	No	No
Hospira	LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER	lidocaine hydrochloride	INJECTABLE;INJECTION	088368-001	Jul 31, 1984		DISCN	No	No
Aurobindo Pharma Ltd	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	207182-002	Oct 30, 2017	AP	RX	No	No
Mylan Labs Ltd	LIDOCAINE HYDROCHLORIDE	lidocaine hydrochloride	INJECTABLE;INJECTION	091058-001	Sep 30, 2010		DISCN	No	No

Expired US Patents for lidocaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven	DENTIPATCH	lidocaine	PATCH;TOPICAL	020575-002	May 21, 1996
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996
Noven	DENTIPATCH	lidocaine	FILM, EXTENDED RELEASE;BUCCAL	020575-001	May 21, 1996
Teikoku Pharma Usa	LIDODERM	lidocaine	PATCH;TOPICAL	020612-001	Mar 19, 1999

International Patents for lidocaine

Country	Patent Number	Estimated Expiration
Mexico	2013013121
Canada	2835595
Taiwan	201249431
European Patent Office	2708229
Taiwan	I543761
Japan	5856153