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FDA Orange Book · active-ingredient family

Imiquimod

Imiquimod is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ZYCLARA · NDA 022483

2

Brand (NDA)

9

Generics (ANDA)

10

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream

ProductApplicantApplicationTEApproved
ZYCLARARLD×2BAUSCHNDA 022483—Jul 15, 2011
ALDARARLDBAUSCHNDA 020723—Feb 27, 1997

Generic (ANDA) products (9)

ProductApplicantApplicationTEApproved
IMIQUIMODTAROANDA 205971ABJan 26, 2021
IMIQUIMODSTRIDES PHARMAANDA 202002—Jun 24, 2014
IMIQUIMODAPOTEX INCANDA 091308—Apr 06, 2012
IMIQUIMODGLENMARK PHARMSANDA 201994ABMar 06, 2012
IMIQUIMODCOSETTEANDA 200481—Apr 18, 2011
IMIQUIMODTAROANDA 200173ABApr 15, 2011
IMIQUIMODENCUBEANDA 091044—Feb 28, 2011
IMIQUIMODPADAGIS ISRAELANDA 078837ABSep 07, 2010
IMIQUIMODFOUGERA PHARMSANDA 078548ABFeb 25, 2010

Listed patents (10)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10238645Aug 18, 2029in 3 yr 3 mo
U-172
8598196Aug 18, 2029in 3 yr 3 mo
U-172
8222270Dec 11, 2029in 3 yr 6 mo
U-68
11318130Dec 11, 2029in 3 yr 6 mo
U-68
8236816Dec 11, 2029in 3 yr 6 mo
U-68
8299109Dec 11, 2029in 3 yr 6 mo
U-68
10238644Dec 11, 2029in 3 yr 6 mo
U-68
11202752Apr 30, 2030in 3 yr 11 mo
U-1455
11850245Apr 30, 2030in 3 yr 11 mo
U-1455
10918635Apr 30, 2030in 3 yr 11 mo
U-172

Imiquimod — frequently asked questions

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

Agent CTA Background

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