Is there a generic for Lidocaine?

Yes. The FDA Orange Book lists 31 approved generic (ANDA) applications for Lidocaine, referencing the brand BONDLIDO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lidocaine?

BONDLIDO (NDA 215029, MEDRX USA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Lidocaine?

The Orange Book lists 9 patents against Lidocaine products, with the earliest listed expiry in 2028. 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.

Does Lidocaine have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Lidocaine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Lidocaine are approved?

Lidocaine is approved in the following dosage forms: aerosol, film, extended release, ointment, patch, solution, suppository, system.

FDA Orange Book · active-ingredient family

Lidocaine

Lidocaine: 8 brands, 31 generics; first approved May 21, 1996; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 31 ANDA applications approved.

Earliest patent expiry Nov 10, 2028Latest exclusivity ends Sep 24, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Nov 10, 2028

in 2 yr 1 mo

Brand (NDA) products

Originator applications

BONDLIDORLDRS
MEDRX USANDA 2150292025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SYSTEM TOPICAL Rx —
ZTLIDORLDRS
SCILEX PHARMSNDA 2079622018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.8% PATCH TOPICAL Rx AB
LIDODERMRLDRS
TEIKOKU PHARMA USANDA 0206121999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
XYLOCAINERLD
ASTRAZENECANDA 008048—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
DENTIPATCH
NOVENNDA 02057519962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
23MG/PATCH FILM, EXTENDED RELEASE BUCCAL Discontinued —
46.1MG/PATCH PATCH TOPICAL Discontinued —
XYLOCAINE
ASTRAZENECANDA 014394—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% AEROSOL ORAL Discontinued —
XYLOCAINE
ASTRAZENECANDA 014127—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% SOLUTION TOPICAL Discontinued —
XYLOCAINE
ASTRAZENECANDA 013077—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG SUPPOSITORY RECTAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SYSTEM	TOPICAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.8%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
23MG/PATCH	FILM, EXTENDED RELEASE	BUCCAL	Discontinued	—
46.1MG/PATCH	PATCH	TOPICAL	Discontinued	—

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	SUPPOSITORY	RECTAL	Discontinued	—

Generic (ANDA) products (31)

Abbreviated applications

LIDOCAINE
USPHARMAANDA 2070592026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
ALKEM LABS LTDANDA 2164842025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
DIFGEN PHARMSANDA 2172212025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.8% PATCH TOPICAL Rx AB
LIDOCAINE
AUROBINDO PHARMA LTDANDA 2171172024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
NAL PHARMANDA 2058822021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
QUAGENANDA 2126952021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
CHARTWELL RXANDA 2086602021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
NOVEN PHARMS INCANDA 2032652020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Discontinued —
LIDOCAINE
AMNEALANDA 2064632020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
IBSAANDA 2091902020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
MACLEODS PHARMSANDA 2116972020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
GENEYORK PHARMSANDA 2124862019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
COSETTE PHARMS NCANDA 2110192018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
STRIDES PHARMAANDA 2109582018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
ALEMBICANDA 2114692018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
TEVA PHARMS USAANDA 2102562018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
VITRUVIAS THERAPANDA 2088222017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
RISINGANDA 2086042017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
ALKEM LABS LTDANDA 2078102017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
GLENMARK PHARMS LTDANDA 2064982016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
ENCUBEANDA 2053182016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
AMNEAL PHARMSANDA 2062972015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
PHARMOBEDIENTANDA 2023462015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
ACTAVIS LABS UT INCANDA 2006752012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% PATCH TOPICAL Rx AB
LIDOCAINE
SEPTODONT INCANDA 0409112011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
ALPHACAINE
CARLISLEANDA 084944—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
ALPHACAINE
CARLISLEANDA 084946—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
ALPHACAINE
CARLISLEANDA 084947—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINE
BELMORA LLCANDA 080210—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Discontinued —
LIDOCAINERLDRS
FOUGERA PHARMS INCANDA 080198—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT
LIDOCAINE
SUN PHARMA CANADAANDA 086724—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% OINTMENT TOPICAL Rx AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.8%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	PATCH	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

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

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
5%	OINTMENT	TOPICAL	Rx	AT

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Sep 24, 2028
in 2 yr

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
8722065	Nov 10, 2028	in 2 yr 1 mo	Product
9925264	May 10, 2031	in 4 yr 8 mo	ProductU-2267
11786455	May 10, 2031	in 4 yr 8 mo	ProductU-2267
11793766	May 10, 2031	in 4 yr 8 mo	U-2267
9283174	May 10, 2031	in 4 yr 8 mo	Product
10765749	May 10, 2031	in 4 yr 8 mo	Product
9931403	May 10, 2031	in 4 yr 8 mo	Product
11278623	May 10, 2031	in 4 yr 8 mo	Product
10765640	May 10, 2031	in 4 yr 8 mo	Product

Approval history

FDA approval span

First approval

May 21, 1996

30 yr 10 mo ago

Most recent approval

Feb 09, 2026

8 mo ago

Approvals span 1996–2026 across 39 FDA applications.

Brand (NDA) 821%

Generic (ANDA) 3179%

Lidocaine: 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.

Related FDA reference tools

Go beyond the database.

Try Assyro Intelligence for your regulatory research. Ready to discuss your team’s workflow? Book a demo.

Try Assyro Intelligence for free Book a demo