FDA Orange Book · active-ingredient family
Letrozole
Letrozole: 1 brand, 20 generics; first approved Jul 25, 1997; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 20 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
20
Listed patents
0
Presentations
21
Brand (NDA) products
Originator applications
- NOVARTIS PHARMSNDA 0207261997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB
Generic (ANDA) products (20)
Abbreviated applications
- LETROZOLEEUGIA PHARMAANDA 2117172019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLEBEIJING YILINGANDA 2058692018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLEHIKMA PHARMSANDA 2037962016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLELANNETT CO INCANDA 2020482014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLECHARTWELL RXANDA 2027162013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEAPOTEX INCANDA 0913032012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEACTAVIS TOTOWAANDA 0902922011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEACCORD HLTHCAREANDA 0909342011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLECARNEGIEANDA 0911912011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLEFRESENIUS KABI USAANDA 0904912011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEHIKMAANDA 0908382011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEIMPAX LABSANDA 0916382011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLEINDICUS PHARMAANDA 2018042011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLELANNETT CO INCANDA 0910982011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLENATCO PHARMA LTDANDA 2001612011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLESTRIDES PHARMA INTLANDA 0907892011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLESUN PHARM INDS LTDANDA 0914662011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLESYNTHON PHARMSANDA 0901962011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued — - LETROZOLETEVA PHARMSANDA 0902892011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Rx AB - LETROZOLEPHARMOBEDIENTANDA 0781902008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
29 yr 8 mo ago
Most recent approval
7 yr 10 mo ago
Approvals span 1997–2019 across 21 FDA applications.
Brand (NDA) 15%
Generic (ANDA) 2095%
Letrozole: 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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