Is there a generic for Imiquimod?

Yes. The FDA Orange Book lists 9 approved generic (ANDA) applications for Imiquimod, referencing the brand ZYCLARA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Imiquimod?

ZYCLARA (NDA 022483, BAUSCH) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Imiquimod?

The Orange Book lists 10 patents against Imiquimod products, with the earliest listed expiry in 2029. 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 Imiquimod are approved?

Imiquimod is approved in the following dosage form: cream.

FDA Orange Book · active-ingredient family

Imiquimod

Imiquimod: 2 brands, 9 generics; first approved Feb 27, 1997; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 9 ANDA applications approved.

Earliest patent expiry Aug 18, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 18, 2029

in 2 yr 10 mo

Brand (NDA) products

Originator applications

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ZYCLARARLDRS
BAUSCHNDA 02248320112 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.75% CREAM TOPICAL Rx AB
2.5% CREAM TOPICAL Rx -
ALDARARLD
BAUSCHNDA 0207231997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.75%	CREAM	TOPICAL	Rx	AB
2.5%	CREAM	TOPICAL	Rx	-

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

Generic (ANDA) products (9)

Abbreviated applications

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IMIQUIMOD
TAROANDA 2059712021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
3.75% CREAM TOPICAL Rx AB
IMIQUIMOD
STRIDES PHARMAANDA 2020022014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Discontinued -
IMIQUIMOD
APOTEX INCANDA 0913082012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Discontinued -
IMIQUIMODRS
GLENMARK PHARMSANDA 2019942012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB
IMIQUIMOD
COSETTE PHARMS NCANDA 2004812011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Discontinued -
IMIQUIMOD
TAROANDA 2001732011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB
IMIQUIMOD
ENCUBEANDA 0910442011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Discontinued -
IMIQUIMOD
PADAGIS ISRAELANDA 0788372010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB
IMIQUIMOD
FOUGERA PHARMSANDA 0785482010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
5% CREAM TOPICAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
3.75%	CREAM	TOPICAL	Rx	AB

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

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

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

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

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

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

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

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

Patent & exclusivity timeline

Protection horizon

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Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10238645	Aug 18, 2029	in 2 yr 10 mo	U-172
8598196	Aug 18, 2029	in 2 yr 10 mo	U-172
8222270	Dec 11, 2029	in 3 yr 2 mo	U-68
11318130	Dec 11, 2029	in 3 yr 2 mo	U-68
8236816	Dec 11, 2029	in 3 yr 2 mo	U-68
8299109	Dec 11, 2029	in 3 yr 2 mo	U-68
10238644	Dec 11, 2029	in 3 yr 2 mo	U-68
11202752	Apr 30, 2030	in 3 yr 7 mo	U-1455
11850245	Apr 30, 2030	in 3 yr 7 mo	U-1455
10918635	Apr 30, 2030	in 3 yr 7 mo	U-172

Approval history

FDA approval span

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First approval

Feb 27, 1997

30 yr 1 mo ago

Most recent approval

Jan 26, 2021

5 yr 10 mo ago

Approvals span 1997–2021 across 11 FDA applications.

Brand (NDA) 218%

Generic (ANDA) 982%

Imiquimod: 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

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