Is there a generic for Econazole nitrate?

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Econazole nitrate, referencing the brand ECOZA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Econazole nitrate?

ECOZA (NDA 205175, RESILIA PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Econazole nitrate?

The Orange Book lists 1 patent against Econazole nitrate products, with the earliest listed expiry in 2031. 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 Econazole nitrate are approved?

Econazole nitrate is approved in the following dosage forms: aerosol, foam, cream.

FDA Orange Book · active-ingredient family

Econazole nitrate

Econazole nitrate: 2 brands, 5 generics; first approved Dec 23, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 5 ANDA applications approved.

Earliest patent expiry Aug 08, 2031

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Aug 08, 2031

in 4 yr 10 mo

Brand (NDA) products

Originator applications

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ECOZARLDRS
RESILIA PHARMSNDA 2051752013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% AEROSOL, FOAM TOPICAL Rx -
SPECTAZOLERLD
ALVOGENNDA 0187511982
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%	AEROSOL, FOAM	TOPICAL	Rx	-

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

Generic (ANDA) products (5)

Abbreviated applications

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ECONAZOLE NITRATE
AUROBINDO PHARMA USAANDA 2103642018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
ECONAZOLE NITRATE
ENCUBEANDA 0765742004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
ECONAZOLE NITRATERS
PADAGIS ISRAELANDA 0764792004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Rx AB
ECONAZOLE NITRATE
CHARTWELL RXANDA 0760752002
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1% CREAM TOPICAL Discontinued -
ECONAZOLE NITRATE
SUN PHARMA CANADAANDA 0760052002
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
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
1%	CREAM	TOPICAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1%	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
10071054	Aug 08, 2031	in 4 yr 10 mo	Product

Approval history

FDA approval span

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First approval

Dec 23, 1982

44 yr 6 mo ago

Most recent approval

Apr 18, 2018

8 yr 8 mo ago

Approvals span 1982–2018 across 7 FDA applications.

Brand (NDA) 229%

Generic (ANDA) 571%

Econazole nitrate: 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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