Is there a generic for Letrozole?

Yes. The FDA Orange Book lists 20 approved generic (ANDA) applications for Letrozole, referencing the brand FEMARA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Letrozole?

FEMARA (NDA 020726, NOVARTIS PHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What dosage forms of Letrozole are approved?

Letrozole is approved in the following dosage form: tablet.

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)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

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FEMARARLDRS
NOVARTIS PHARMSNDA 0207261997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (20)

Abbreviated applications

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LETROZOLE
EUGIA PHARMAANDA 2117172019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
BEIJING YILINGANDA 2058692018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
HIKMA PHARMSANDA 2037962016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
LANNETT CO INCANDA 2020482014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
CHARTWELL RXANDA 2027162013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
APOTEX INCANDA 0913032012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
ACTAVIS TOTOWAANDA 0902922011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
ACCORD HLTHCAREANDA 0909342011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
CARNEGIEANDA 0911912011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
FRESENIUS KABI USAANDA 0904912011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
HIKMAANDA 0908382011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
IMPAX LABSANDA 0916382011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
INDICUS PHARMAANDA 2018042011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
LANNETT CO INCANDA 0910982011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
NATCO PHARMA LTDANDA 2001612011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
STRIDES PHARMA INTLANDA 0907892011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
SUN PHARM INDS LTDANDA 0914662011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
SYNTHON PHARMSANDA 0901962011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -
LETROZOLE
TEVA PHARMSANDA 0902892011
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Rx AB
LETROZOLE
PHARMOBEDIENTANDA 0781902008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2.5MG TABLET ORAL Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2.5MG	TABLET	ORAL	Rx	AB

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

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First approval

Jul 25, 1997

29 yr 8 mo ago

Most recent approval

Jan 11, 2019

7 yr 11 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

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