Is there a generic for Clotrimazole?

Yes. The FDA Orange Book lists 14 approved generic (ANDA) applications for Clotrimazole, referencing the brand CLOTIC. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clotrimazole?

CLOTIC (NDA 217628, CARWIN PHARM ASSOC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Clotrimazole?

The Orange Book lists 1 patent against Clotrimazole products, with the earliest listed expiry in 2042. 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.

Does Clotrimazole have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Clotrimazole. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Clotrimazole are approved?

Clotrimazole is approved in the following dosage forms: cream, cream, tablet, lotion, solution, solution/drops, tablet, troche/lozenge.

FDA Orange Book · active-ingredient family

Clotrimazole

Clotrimazole: 18 brands, 14 generics; first approved Jun 17, 1983; generic available.

Generic available4 exclusivity periodsHas discontinued products

Generic status & protection

Generic available: 14 ANDA applications approved.

Earliest patent expiry May 26, 2042Latest exclusivity ends Sep 26, 2037

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 26, 2042

in 16 yr

Brand (NDA) products

Originator applications

CLOTICRLDRS
CARWIN PHARM ASSOCNDA 2176282025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION/DROPS OTIC Rx —
GYNE-LOTRIMIN 3RLD
BAYER HEALTHCARE LLCNDA 0205741998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL Discontinued —
GYNE-LOTRIMIN 3 COMBINATION PACKRLD
BAYER HEALTHCARE LLCNDA 0205261996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1%,200MG CREAM, TABLET TOPICAL, VAGINAL Discontinued —
GYNE-LOTRIMIN 3RLD
BAYER HEALTHCARE LLCNDA 0205251996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET VAGINAL Discontinued —
GYNE-LOTRIMIN COMBINATION PACKRLD
BAYER HEALTHCARE LLCNDA 0202891993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1%,100MG CREAM, TABLET TOPICAL, VAGINAL Discontinued —
GYNE-LOTRIMINRLD
BAYER HEALTHCARE LLCNDA 0180521990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM VAGINAL Discontinued —
GYNE-LOTRIMINRLD
BAYER HEALTHCARE LLCNDA 0177171990
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET VAGINAL Discontinued —
MYCELEXRLD
BAYER HLTHCARENDA 0187131983
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TROCHE/LOZENGE ORAL Discontinued —
LOTRIMINRLD
SCHERING PLOUGHNDA 017619—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued —
LOTRIMINRLD
SCHERING PLOUGHNDA 017613—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Discontinued —
MYCELEXRLD
BAYER HLTHCARENDA 018181—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Discontinued —
TRIVAGIZOLE 3
SUN PHARMA CANADANDA 0211432000
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2% CREAM VAGINAL OTC —
MYCELEX-7 COMBINATION PACK
BAYER HEALTHCARE LLCNDA 0203891994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1%,100MG CREAM, TABLET TOPICAL, VAGINAL Discontinued —
MYCELEX-7
BAYER HEALTHCARE LLCNDA 0182301991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM VAGINAL Discontinued —
MYCELEX-7
BAYER HEALTHCARE LLCNDA 0181821991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET VAGINAL Discontinued —
MYCELEX-G
BAYER PHARMSNDA 0190691985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET VAGINAL Discontinued —
LOTRIMIN
SCHERINGNDA 0188131984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% LOTION TOPICAL Discontinued —
MYCELEX
BAYER HEALTHCARE LLCNDA 018183—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	SOLUTION/DROPS	OTIC	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%,200MG	CREAM, TABLET	TOPICAL, VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
200MG	TABLET	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%,100MG	CREAM, TABLET	TOPICAL, VAGINAL	Discontinued	—

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TROCHE/LOZENGE	ORAL	Discontinued	—

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2%	CREAM	VAGINAL	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%,100MG	CREAM, TABLET	TOPICAL, VAGINAL	Discontinued	—

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	VAGINAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET	VAGINAL	Discontinued	—

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

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

Generic (ANDA) products (14)

Abbreviated applications

CLOTRIMAZOLE
THINQ PHARM-CRO PVTANDA 2156412024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TROCHE/LOZENGE ORAL Rx AB
CLOTRIMAZOLE
SCIEGEN PHARMSANDA 2165692023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Rx AT
CLOTRIMAZOLE
TP ANDA HOLDINGSANDA 2122812019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Rx AT
CLOTRIMAZOLE
NOVITIUM PHARMAANDA 2098152019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Rx AT
CLOTRIMAZOLE
GLENMARK PHARMSANDA 0902192010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
CLOTRIMAZOLE
FOUGERA PHARMSANDA 0783382008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
CLOTRIMAZOLE
PADAGIS USANDA 0767632005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TROCHE/LOZENGE ORAL Rx AB
CLOTRIMAZOLERS
HIKMAANDA 0763872004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG TROCHE/LOZENGE ORAL Rx AB
GYNIX
TEVA PHARMSANDA 0732491998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG TABLET VAGINAL Discontinued —
CLOTRIMAZOLERS
SUN PHARMA CANADAANDA 0745801996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Rx AT
CLOTRIMAZOLE
SUN PHARMA CANADAANDA 0726411995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM VAGINAL OTC —
CLOTRIMAZOLE
TEVAANDA 0733061995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% SOLUTION TOPICAL Rx AT
CLOTRIMAZOLERS
SUN PHARMA CANADAANDA 0726401993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
CLOTRIMAZOLERS
ENCUBEANDA 0741651993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM VAGINAL OTC —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TROCHE/LOZENGE	ORAL	Rx	AB

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

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

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

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

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TROCHE/LOZENGE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG	TROCHE/LOZENGE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	TABLET	VAGINAL	Discontinued	—

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

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

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

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

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

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Sep 26, 2028
in 2 yr 2 mo
ODE-549Orphan-drug exclusivity (7 years)
Sep 26, 2032
in 6 yr 3 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2037
in 11 yr 3 mo
GAINQualified infectious disease product exclusivity (adds 5 years)
Sep 26, 2033
in 7 yr 3 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
12246006	May 26, 2042	in 16 yr	ProductU-4276

Approval history

FDA approval span

First approval

Jun 17, 1983

43 yr 9 mo ago

Most recent approval

Sep 26, 2025

11 mo ago

Approvals span 1983–2025 across 32 FDA applications.

Brand (NDA) 1856%

Generic (ANDA) 1444%

Clotrimazole: 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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