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
Brands (NDA)
5
Generics (ANDA)
14
Listed patents
6
Next patent expiry
Oct 03, 2028
in 2 yr
Brand (NDA) products
Originator applications
- MAYNE PHARMANDA 2089012018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 65MG CAPSULE ORAL Rx — - ONMELRLDSEBELA IRELAND LTDNDA 0224842010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG TABLET ORAL Discontinued — - SPORANOXRLDJANSSEN PHARMSNDA 0206571997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Discontinued — - JANSSEN PHARMSNDA 0200831992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - JANSSEN PHARMSNDA 0209661999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (14)
Abbreviated applications
- ITRACONAZOLEANNORA PHARMAANDA 2122392020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - ITRACONAZOLEAPOTEXANDA 2084812019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Discontinued — - ITRACONAZOLESTRIDES PHARMAANDA 2064102019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - ITRACONAZOLETORRENTANDA 2094602018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLEZYDUS PHARMSANDA 2046722017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLEALKEM LABS LTDANDA 2085912017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLEJUBILANT GENERICSANDA 2034452017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - ITRACONAZOLEALEMBICANDA 2067412016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLERISINGANDA 2057242016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLEAMNEAL PHARMSANDA 2050802016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB - ITRACONAZOLEACCORD HLTHCAREANDA 2059912016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - ITRACONAZOLERSAMNEAL PHARMSANDA 2055732015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SOLUTION ORAL Rx AA - ITRACONAZOLEMYLAN PHARMS INCANDA 2004632012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — - ITRACONAZOLESANDOZANDA 0761042004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8486456 | in 2 yr | ProductU-1054 | |
| 10463740 | in 6 yr 10 mo | ProductU-2453 | |
| 9713642 | in 6 yr 10 mo | U-2453 | |
| 10806792 | in 6 yr 10 mo | Product | |
| 8921374 | in 6 yr 10 mo | Product | |
| 9272046 | in 6 yr 10 mo | Product |
Approval history
FDA approval span
First approval
34 yr 7 mo ago
Most recent approval
6 yr 2 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.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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