Is there a generic for Itraconazole?

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

What is the reference-listed drug for Itraconazole?

TOLSURA (NDA 208901, MAYNE PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Itraconazole?

The Orange Book lists 6 patents against Itraconazole products, with the earliest listed expiry in 2028. 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 Itraconazole are approved?

Itraconazole is approved in the following dosage forms: capsule, injectable, solution, tablet.

FDA Orange Book · active-ingredient family

Itraconazole

Itraconazole: 5 brands, 14 generics; first approved Sep 11, 1992; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 14 ANDA applications approved.

Earliest patent expiry Oct 03, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Oct 03, 2028

in 2 yr

Brand (NDA) products

Originator applications

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TOLSURARLDRS
MAYNE PHARMANDA 2089012018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
65MG CAPSULE ORAL Rx -
ONMELRLD
SEBELA IRELAND LTDNDA 0224842010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
200MG TABLET ORAL Discontinued -
SPORANOXRLD
JANSSEN PHARMSNDA 0206571997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Discontinued -
SPORANOXRLDRS
JANSSEN PHARMSNDA 0200831992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
SPORANOX
JANSSEN PHARMSNDA 0209661999
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
65MG	CAPSULE	ORAL	Rx	-

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

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	INJECTABLE	INJECTION	Discontinued	-

Generic (ANDA) products (14)

Abbreviated applications

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ITRACONAZOLE
ANNORA PHARMAANDA 2122392020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Rx AA
ITRACONAZOLE
APOTEXANDA 2084812019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Discontinued -
ITRACONAZOLE
STRIDES PHARMAANDA 2064102019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Discontinued -
ITRACONAZOLE
TORRENTANDA 2094602018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
ZYDUS PHARMSANDA 2046722017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
ALKEM LABS LTDANDA 2085912017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
JUBILANT GENERICSANDA 2034452017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Discontinued -
ITRACONAZOLE
ALEMBICANDA 2067412016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
RISINGANDA 2057242016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
AMNEAL PHARMSANDA 2050802016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB
ITRACONAZOLE
ACCORD HLTHCAREANDA 2059912016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Discontinued -
ITRACONAZOLERS
AMNEAL PHARMSANDA 2055732015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MG/ML SOLUTION ORAL Rx AA
ITRACONAZOLE
MYLAN PHARMS INCANDA 2004632012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Discontinued -
ITRACONAZOLE
SANDOZANDA 0761042004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
100MG CAPSULE ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SOLUTION	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MG/ML	SOLUTION	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
100MG	CAPSULE	ORAL	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
8486456	Oct 03, 2028	in 2 yr	ProductU-1054
10463740	Jun 21, 2033	in 6 yr 9 mo	ProductU-2453
9713642	Jun 21, 2033	in 6 yr 9 mo	U-2453
10806792	Jun 21, 2033	in 6 yr 9 mo	Product
8921374	Jun 21, 2033	in 6 yr 9 mo	Product
9272046	Jun 21, 2033	in 6 yr 9 mo	Product

Approval history

FDA approval span

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First approval

Sep 11, 1992

34 yr 7 mo ago

Most recent approval

Sep 01, 2020

6 yr 3 mo ago

Approvals span 1992–2020 across 19 FDA applications.

Brand (NDA) 526%

Generic (ANDA) 1474%

Itraconazole: 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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Key facts