Assyro AI

FDA Orange Book · active-ingredient family

Clotrimazole

Clotrimazole is approved as 18 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CLOTIC · NDA 217628

18

Brand (NDA)

14

Generics (ANDA)

1

Listed patents

4

Exclusivity periods

Brand (NDA) products · cream, cream, tablet, lotion, solution, solution/drops, tablet, troche/lozenge

ProductApplicantApplicationTEApproved
CLOTICRLDCARWIN PHARM ASSOCNDA 217628—Sep 26, 2025
GYNE-LOTRIMIN 3RLDBAYER HEALTHCARE LLCNDA 020574—Nov 24, 1998
GYNE-LOTRIMIN 3 COMBINATION PACKRLDBAYER HEALTHCARE LLCNDA 020526—Jul 29, 1996
GYNE-LOTRIMIN 3RLDBAYER HEALTHCARE LLCNDA 020525—Jul 29, 1996
GYNE-LOTRIMIN COMBINATION PACKRLDBAYER HEALTHCARE LLCNDA 020289—Apr 26, 1993
GYNE-LOTRIMINRLDBAYER HEALTHCARE LLCNDA 018052—Nov 30, 1990
GYNE-LOTRIMINRLDBAYER HEALTHCARE LLCNDA 017717—Nov 30, 1990
MYCELEXRLDBAYER HLTHCARENDA 018713—Jun 17, 1983
LOTRIMINRLDSCHERING PLOUGHNDA 017619—Approved Prior to Jan 1, 1982
LOTRIMINRLDSCHERING PLOUGHNDA 017613—Approved Prior to Jan 1, 1982
MYCELEXRLDBAYER HLTHCARENDA 018181—Approved Prior to Jan 1, 1982
TRIVAGIZOLE 3SUN PHARMA CANADANDA 021143—Apr 12, 2000
MYCELEX-7 COMBINATION PACKBAYER HEALTHCARE LLCNDA 020389—Jun 23, 1994
MYCELEX-7BAYER HEALTHCARE LLCNDA 018230—Dec 26, 1991
MYCELEX-7BAYER HEALTHCARE LLCNDA 018182—Dec 26, 1991
MYCELEX-GBAYER PHARMSNDA 019069—Apr 19, 1985
LOTRIMINSCHERINGNDA 018813—Feb 17, 1984
MYCELEXBAYER HEALTHCARE LLCNDA 018183—Approved Prior to Jan 1, 1982

Generic (ANDA) products (14)

ProductApplicantApplicationTEApproved
CLOTRIMAZOLETHINQ PHARM-CRO PVTANDA 215641ABFeb 29, 2024
CLOTRIMAZOLESCIEGEN PHARMSANDA 216569ATOct 16, 2023
CLOTRIMAZOLETP ANDA HOLDINGSANDA 212281ATJul 25, 2019
CLOTRIMAZOLENOVITIUM PHARMAANDA 209815ATFeb 14, 2019
CLOTRIMAZOLEGLENMARK PHARMSANDA 090219ABAug 03, 2010
CLOTRIMAZOLEFOUGERA PHARMSANDA 078338ABSep 02, 2008
CLOTRIMAZOLEPADAGIS USANDA 076763ABOct 28, 2005
CLOTRIMAZOLEHIKMAANDA 076387ABJul 29, 2004
GYNIXTEVA PHARMSANDA 073249—Feb 13, 1998
CLOTRIMAZOLESUN PHARMA CANADAANDA 074580ATJul 29, 1996
CLOTRIMAZOLESUN PHARMA CANADAANDA 072641—Dec 04, 1995
CLOTRIMAZOLETEVAANDA 073306ATFeb 28, 1995
CLOTRIMAZOLESUN PHARMA CANADAANDA 072640ABAug 31, 1993
CLOTRIMAZOLEENCUBEANDA 074165—Jul 16, 1993

Marketing exclusivity (4)

  • NPNew product exclusivity (3 years)

    Sep 26, 2028

    in 2 yr 4 mo

  • ODE-549Orphan-drug exclusivity (7 years)

    Sep 26, 2032

    in 6 yr 4 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Sep 26, 2037

    in 11 yr 5 mo

  • GAINQualified infectious disease product exclusivity (adds 5 years)

    Sep 26, 2033

    in 7 yr 5 mo

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
12246006May 26, 2042in 16 yr 2 mo
ProductU-4276

Clotrimazole — 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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