Is there a generic for Lidocaine hydrochloride?

Yes. The FDA Orange Book lists 94 approved generic (ANDA) applications for Lidocaine hydrochloride, referencing the brand AKTEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lidocaine hydrochloride?

AKTEN (NDA 022221, THEA PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Lidocaine hydrochloride?

The Orange Book lists 4 patents against Lidocaine hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lidocaine hydrochloride are approved?

Lidocaine hydrochloride is approved in the following dosage forms: gel, injectable, jelly, solution, system.

FDA Orange Book · active-ingredient family

Lidocaine hydrochloride

Lidocaine hydrochloride: 22 brands, 94 generics; first approved Feb 02, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 94 ANDA applications approved.

Earliest patent expiry Jul 24, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 24, 2026

3 mo ago

Brand (NDA) products

Originator applications

AKTENRLDRS
THEA PHARMANDA 0222212008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.5% GEL OPHTHALMIC Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.5%	GEL	OPHTHALMIC	Rx	—

XYLOCAINE PRESERVATIVE FREERLD

FRESENIUS KABI USANDA 01680119885 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Discontinued	—
4%	INJECTABLE	INJECTION	Discontinued	—
10%	INJECTABLE	INJECTION	Discontinued	—
20%	INJECTABLE	INJECTION	Discontinued	—
1%	INJECTABLE	INJECTION	Discontinued	—

XYLOCAINERLDRS
FRESENIUS KABI USANDA 006488—4 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
0.5% INJECTABLE INJECTION Rx AP
1.5% INJECTABLE INJECTION Rx AP
XYLOCAINE 4% PRESERVATIVE FREERLD
FRESENIUS KABI USANDA 010417—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Discontinued —
4% SOLUTION TOPICAL Discontinued —
XYLOCAINERLD
EPIC PHARMA LLCNDA 008816—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued —
XYLOCAINE VISCOUSRLD
FRESENIUS KABI USANDA 009470—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued —
ZINGO
POWDER PHARMSNDA 0221142007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG SYSTEM INTRADERMAL Discontinued —
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUNNDA 01983019923 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/100ML INJECTABLE INJECTION Rx AP
400MG/100ML INJECTABLE INJECTION Rx AP
800MG/100ML INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTTNDA 0189541985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG/100ML INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Rx	AP
1%	INJECTABLE	INJECTION	Rx	AP
0.5%	INJECTABLE	INJECTION	Rx	AP
1.5%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	INJECTABLE	INJECTION	Discontinued	—
4%	SOLUTION	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	SYSTEM	INTRADERMAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Rx	AP
400MG/100ML	INJECTABLE	INJECTION	Rx	AP
800MG/100ML	INJECTABLE	INJECTION	Rx	AP

LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER

B BRAUNNDA 01896719843 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Discontinued	—
400MG/100ML	INJECTABLE	INJECTION	Discontinued	—
800MG/100ML	INJECTABLE	INJECTION	Discontinued	—

XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECANDA 0104961982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% INJECTABLE SPINAL Discontinued —
LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARMNDA 017508—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
4% INJECTABLE INJECTION Discontinued —
20% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONNDA 017701—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONNDA 018543—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1GM/VIAL INJECTABLE INJECTION Discontinued —
2GM/VIAL INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	INJECTABLE	SPINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1GM/VIAL	INJECTABLE	INJECTION	Discontinued	—
2GM/VIAL	INJECTABLE	INJECTION	Discontinued	—

LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER

BAXTER HLTHCARENDA 018461—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG/100ML	INJECTABLE	INJECTION	Discontinued	—
200MG/100ML	INJECTABLE	INJECTION	Rx	AP
400MG/100ML	INJECTABLE	INJECTION	Rx	AP
800MG/100ML	INJECTABLE	INJECTION	Rx	AP

LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER

HOSPIRANDA 018388—3 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG/100ML	INJECTABLE	INJECTION	Discontinued	—
400MG/100ML	INJECTABLE	INJECTION	Discontinued	—
800MG/100ML	INJECTABLE	INJECTION	Discontinued	—

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
FRESENIUS KABI USANDA 017584—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
4% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATIONNDA 017702—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued —
4% INJECTABLE INJECTION Discontinued —
LIDOPEN
MERIDIAN MEDCL TECHNNDA 017549—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued —
XYLOCAINE
ASTRAZENECANDA 010418—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
1.5% INJECTABLE INJECTION Discontinued —
XYLOCAINE DENTAL
DENTSPLY PHARMNDA 021380—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
FRESENIUS KABI USANDA 016297—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE SPINAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	INJECTABLE	INJECTION	Rx	AP
4%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	INJECTABLE	INJECTION	Discontinued	—
4%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.5%	INJECTABLE	SPINAL	Discontinued	—

Generic (ANDA) products (94)

Abbreviated applications

LIDOCAINE HYDROCHLORIDE
QUAGENANDA 2186762026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
VIWIT PHARMANDA 22007120262 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 2197592025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
ANTHEA PHARMAANDA 21953520252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
THE J MOLNERANDA 2184112024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
PAI HOLDINGS PHARMANDA 2181382024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
SUN PHARMA CANADAANDA 2181822023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
MANKIND PHARMAANDA 21769320232 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
MANKIND PHARMAANDA 21769220233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDERS
RUBICON RESEARCHANDA 2167802023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
YILINGANDA 21426720222 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AFAXYSANDA 2151322022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
YILINGANDA 2142692022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
NOVITIUM PHARMAANDA 2162502022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
ASPIROANDA 21433620212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
ASPIROANDA 21433920212 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HUONSANDA 21282120202 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
B BRAUN MEDICALANDA 2084742018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
SPECTRA MDCL DEVICESANDA 2080172018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
EUGIA PHARMAANDA 20718220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
AM REGENTANDA 0915642015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
GLYDORS
SAGENT PHARMS INCANDA 2010942014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
RISINGANDA 2022422014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
PAI HOLDINGS PHARMANDA 2044942014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
EUGIA PHARMAANDA 20304020132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
EUGIA PHARMAANDA 20308220132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
WATSON LABS INCANDA 0408372011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
RISINGANDA 09105620102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued —
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
RISINGANDA 09105820102 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued —
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
CHARTWELL RXANDA 0906652010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE VISCOUS
CHARTWELL MOLECULARANDA 0407082007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
LANNETT CO INCANDA 0407102007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE
SENTISSANDA 0404332003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
HOSPIRAANDA 04030219982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HIKMAANDA 0400141995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued —
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0400131995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0400781995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
COSETTE PHARMS NCANDA 0813181993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
PACOANDA 0896881989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
ABBOTTANDA 0893621988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued —
LIDOCAINE VISCOUS
HIKMAANDA 0888021985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDERS
HIKMAANDA 0888031985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883251984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0882991984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883261984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883271984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883671984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRAANDA 0883681984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% INJECTABLE INJECTION Discontinued —
LTA II KIT
HOSPIRAANDA 0885421984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued —
PEDIATRIC LTA KIT
ABBOTTANDA 0885721984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883281984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883291984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883301984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.5% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0882941984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
HOSPIRAANDA 0883311984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREERS
HOSPIRAANDA 0882951984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Rx AP
LIDOCATON
PHARMATONANDA 0847271983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LARYNGOTRACHEAL ANESTHESIA KIT
KENDALL ILANDA 0879311983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
ABBOTTANDA 0879801983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
PHARMOBEDIENTANDA 0878721982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Rx AT
LIDOCAINE HYDROCHLORIDE
PHARMOBEDIENTANDA 0878811982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
INTL MEDICATIONANDA 0863891982
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued —
ALPHACAINE HYDROCHLORIDE
CARLISLEANDA 084721—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	SOLUTION	ORAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
4%	SOLUTION	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Rx	AP
2%	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	JELLY	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	INJECTABLE	INJECTION	Discontinued	—
1%	INJECTABLE	INJECTION	Discontinued	—

LIDOCAINE HYDROCHLORIDE

ABRAXIS PHARMANDA 080420—4 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Discontinued	—
2%	INJECTABLE	INJECTION	Discontinued	—
2%	INJECTABLE	INJECTION	Discontinued	—
1.5%	INJECTABLE	INJECTION	Discontinued	—

LIDOCAINE HYDROCHLORIDE
ABRAXIS PHARMANDA 086761—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
AM REGENTANDA 080850—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
BEL MARANDA 080710—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
BEL MARANDA 080760—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
BELMORA LLCANDA 080504—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
DELL LABSANDA 083387—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
DELL LABSANDA 083388—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
ELKINS SINNANDA 085131—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
ELKINS SINNANDA 084626—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
EPIC PHARMA LLCANDA 085037—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
FRESENIUS KABI USAANDA 088586—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
GD SEARLE LLCANDA 083135—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —

LIDOCAINE HYDROCHLORIDERLD

HOSPIRAANDA 083158—5 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	INJECTABLE	INJECTION	Discontinued	—
2%	INJECTABLE	INJECTION	Discontinued	—
20%	INJECTABLE	INJECTION	Discontinued	—
200MG/100ML	INJECTABLE	INJECTION	Discontinued	—
400MG/100ML	INJECTABLE	INJECTION	Discontinued	—

LIDOCAINE HYDROCHLORIDERLD
INTL MEDICATIONANDA 083173—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
LUITPOLDANDA 083198—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
LYPHOMEDANDA 080390—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
MILESANDA 080414—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
WATSON LABSANDA 080377—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
WATSON LABSANDA 083627—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE
WEST-WARD PHARMS INTANDA 080407—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE
WYETH AYERSTANDA 083083—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Discontinued —
2% INJECTABLE INJECTION Discontinued —
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HIKMAANDA 084625—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
2% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRAANDA 080408—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% INJECTABLE INJECTION Rx AP
1.5% INJECTABLE INJECTION Rx AP
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%RLDRS
HOSPIRAANDA 083914—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% INJECTABLE SPINAL Rx —
ANESTACON
BIONPHARMAANDA 080429—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Discontinued —
LIDOCAINE HYDROCHLORIDE
INTL MEDICATIONANDA 086283—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% JELLY TOPICAL Rx AT
LIDOCAINE HYDROCHLORIDE VISCOUS
ACTAVIS MID ATLANTICANDA 086578—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION ORAL Discontinued —
LARYNG-O-JET KIT
INTL MEDICATIONANDA 086364—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Rx AT
LTA II KIT
HOSPIRAANDA 080409—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
4% SOLUTION TOPICAL Discontinued —
PEDIATRIC LTA KIT
HOSPIRAANDA 085995—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% SOLUTION TOPICAL Discontinued —

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8759401	Jul 24, 2026	3 mo ago	ProductU-1523
8540665	Oct 22, 2029	in 3 yr 1 mo	U-1438
9358338	Apr 27, 2035	in 8 yr 8 mo	U-1870
9370622	Sep 28, 2035	in 9 yr 1 mo	U-1870

Approval history

FDA approval span

First approval

Feb 02, 1982

45 yr 4 mo ago

Most recent approval

Mar 20, 2026

7 mo ago

Approvals span 1982–2026 across 116 FDA applications.

Brand (NDA) 2219%

Generic (ANDA) 9481%

Lidocaine hydrochloride: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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