FDA Orange Book

Generic for Ztlido

Ztlido contains lidocaine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Ztlido is lidocaine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Ztlido products in the Orange Book

Ztlido products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
patch, topical	1.8%	Marketed (Rx)	AB	1	AB

NDA 207962, held by SCILEX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic lidocaine

Approved generic versions of Ztlido
Company	ANDA	TE code	Approved	Strengths
DIFGEN PHARMACEUTICALS LLC	217221	AB (A-rated, therapeutically equivalent)	March 25, 2025	1.8%

Ztlido patents

Patents listed for Ztlido
Patent	Expires	Covers	Use code	NDA
9925264	May 10, 2031	Drug product	U-2267	207962
11786455	May 10, 2031	Drug product	U-2267	207962
11793766	May 10, 2031	Method of use	U-2267	207962
9283174	May 10, 2031	Drug product	None	207962
10765749	May 10, 2031	Drug product	None	207962
9931403	May 10, 2031	Drug product	None	207962
11278623	May 10, 2031	Drug product	None	207962
10765640	May 10, 2031	Drug product	None	207962

Ztlido NDC codes

69557-111

Questions

Is there a generic for Ztlido?

Yes. The generic name for Ztlido is lidocaine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Ztlido?

The active ingredient in Ztlido is lidocaine, per the FDA Orange Book.

When does the Ztlido patent expire?

The last patent listed for Ztlido in the Orange Book expires May 10, 2031. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.