Is there a generic for Luliconazole?

The FDA Orange Book does not currently list an approved generic (ANDA) for Luliconazole. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Luliconazole?

LUZU (NDA 204153, BAUSCH) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Luliconazole?

The Orange Book lists 4 patents against Luliconazole products, with the earliest listed expiry in 2033. 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 Luliconazole are approved?

Luliconazole is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Luliconazole

Luliconazole: 1 brand, 0 generics; first approved Nov 14, 2013; on patent until Sep 06, 2033.

On patent

Generic status & protection

Protected until Sep 06, 2033 (earliest listed patent expiry).

Earliest patent expiry Sep 06, 2033

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Sep 06, 2033

in 7 yr 3 mo

Originator applications

Brand (NDA) products

LUZURLDRS

BAUSCHNDA 2041532013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	CREAM	TOPICAL	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9012484	Sep 06, 2033	in 7 yr 3 mo	SubstanceProductU-540
9453006	Sep 06, 2033	in 7 yr 3 mo	Substance
9199977	Sep 06, 2033	in 7 yr 3 mo	SubstanceProduct
8980931	Apr 28, 2034	in 7 yr 11 mo	Product

FDA approval span

Approval history

First approval

Nov 14, 2013

12 yr 10 mo ago

Most recent approval

Nov 14, 2013

12 yr 10 mo ago

All 1 application were approved in 2013.

Brand (NDA) 1100%

Generic (ANDA) 00%

Luliconazole — 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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