Is there a generic for Estradiol?

Yes. The FDA Orange Book lists 41 approved generic (ANDA) applications for Estradiol, referencing the brand IMVEXXY. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Estradiol?

IMVEXXY (NDA 208564, MAYNE PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Estradiol?

The Orange Book lists 24 patents against Estradiol 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 Estradiol are approved?

Estradiol is approved in the following dosage forms: cream, film, extended release, gel, gel, metered, insert, insert, extended release, spray, system, tablet.

FDA Orange Book · active-ingredient family

Estradiol

Estradiol: 17 brands, 41 generics; first approved Jan 31, 1984; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 41 ANDA applications approved.

Earliest patent expiry Jul 10, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 10, 2028

in 1 yr 11 mo

Brand (NDA) products

Originator applications

IMVEXXYRLDRS
MAYNE PHARMANDA 20856420182 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG INSERT VAGINAL Rx AB
0.01MG INSERT VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG	INSERT	VAGINAL	Rx	AB
0.01MG	INSERT	VAGINAL	Rx	AB

MINIVELLERLD

NOVENNDA 20375220145 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3

VAGIFEMRLDRS
NOVO NORDISK INCNDA 02090820092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
25MCG TABLET VAGINAL Discontinued —
10MCG TABLET VAGINAL Rx AB
EVAMISTRLDRS
PADAGIS USNDA 0220142007
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1.53MG/SPRAY SPRAY TRANSDERMAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25MCG	TABLET	VAGINAL	Discontinued	—
10MCG	TABLET	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1.53MG/SPRAY	SPRAY	TRANSDERMAL	Rx	—

DIVIGELRLDRS

VERTICAL PHARMSNDA 02203820075 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ELESTRINRLDRS
VIATRISNDA 0218132006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% (0.87GM/ACTIVATION) GEL, METERED TRANSDERMAL Rx —
MENOSTARRLDRS
BAYER HLTHCARENDA 0216742004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.014MG/24HR SYSTEM TRANSDERMAL Rx AB
ESTROGELRLDRS
ASCEND THERAPS USNDA 02116620042 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% GEL TOPICAL Discontinued —
0.06% (1.25GM/ACTIVATION) GEL, METERED TRANSDERMAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06% (0.87GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.014MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06%	GEL	TOPICAL	Discontinued	—
0.06% (1.25GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Rx	AB

VIVELLE-DOTRLD

SANDOZNDA 02053820025 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.05MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.075MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.1MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.025MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1

CLIMARARLD

BAYER HLTHCARENDA 02037519996 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.06MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

ESTRINGRLDRS
PFIZERNDA 0204721996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.0075MG/24HR INSERT, EXTENDED RELEASE VAGINAL Rx —
ESTRADERMRLD
NOVARTISNDA 01908119862 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.05MG/24HR SYSTEM TRANSDERMAL Discontinued —
0.1MG/24HR SYSTEM TRANSDERMAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.0075MG/24HR	INSERT, EXTENDED RELEASE	VAGINAL	Rx	—

ALORA

ABBVIENDA 02065520024 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

VIVELLE

SANDOZNDA 02032320005 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.05MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.075MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.1MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.025MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—

ESTRADIOL

ORTHO MCNEIL PHARMNDA 02104819993 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.075MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.1MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—

ESCLIM

WOMEN FIRST HLTHCARENDA 02084719985 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.05MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.075MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—
0.1MG/24HR	SYSTEM	TRANSDERMAL	Discontinued	—

FEMPATCH
PARKE DAVISNDA 0204171996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Discontinued	—

Generic (ANDA) products (41)

Abbreviated applications

ESTRADIOL
ENCUBEANDA 2182142026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% (1.25GM/ACTIVATION) GEL, METERED TRANSDERMAL Rx AB
ESTRADIOL
PADAGIS USANDA 2150962026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% (1.25GM/ACTIVATION) GEL, METERED TRANSDERMAL Discontinued —
ESTRADIOL
TEVA PHARMS USA INCANDA 21413720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.004MG INSERT VAGINAL Rx AB
0.01MG INSERT VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06% (1.25GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06% (1.25GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.004MG	INSERT	VAGINAL	Rx	AB
0.01MG	INSERT	VAGINAL	Rx	AB

ESTRADIOL

ENCUBEANDA 21850720255 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ESTRADIOL
NOVITIUM PHARMAANDA 2178822024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% (1.25GM/ACTIVATION) GEL, METERED TRANSDERMAL Rx AB
ESTRADIOL
AUROBINDO PHARMAANDA 2165502024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MCG TABLET VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06% (1.25GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MCG	TABLET	VAGINAL	Rx	AB

ESTRADIOL

AMNEALANDA 21605520245 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ESTRADIOL

SOLARIS PHARMA CORPANDA 21786320245 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ESTRADIOL
SOLARIS PHARMA CORPANDA 2161602024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.06% (1.25GM/ACTIVATION) GEL, METERED TRANSDERMAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.06% (1.25GM/ACTIVATION)	GEL, METERED	TRANSDERMAL	Rx	AB

ESTRADIOL

PADAGIS ISRAELANDA 21652420235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ESTRADIOL
NOVITIUM PHARMAANDA 21733420233 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

ESTRADIOL

NOVITIUM PHARMAANDA 21761020235 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1% (0.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.5GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (0.75GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1GM/PACKET)	GEL	TRANSDERMAL	Rx	AB
0.1% (1.25GM/PACKET)	GEL	TRANSDERMAL	Rx	AB

ESTRADIOL
ZYDUS PHARMSANDA 2043792023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.014MG/24HR SYSTEM TRANSDERMAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.014MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB

ESTRADIOL

ZYDUS PHARMSANDA 20298520236 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.06MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

ESTRADIOL

ZYDUS PHARMSANDA 20624120225 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.05MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.075MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.1MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1

ESTRADIOL
XIROMEDANDA 21178320223 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% (0.25GM/PACKET) GEL TRANSDERMAL Rx AB
0.1% (0.5GM/PACKET) GEL TRANSDERMAL Rx AB
0.1% (1GM/PACKET) GEL TRANSDERMAL Rx AB
ESTRADIOL
PRASCOANDA 2123132021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	VAGINAL	Rx	AB

ESTRADIOL

AMNEALANDA 21139620205 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3

ESTRADIOL

AMNEALANDA 21129320195 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.05MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.075MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.1MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1

ESTRADIOL
GLENMARK PHARMS LTDANDA 2102642018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MCG TABLET VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MCG	TABLET	VAGINAL	Rx	AB

ESTRADIOL

MYLAN TECHNOLOGIESANDA 20668520185 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB3

ESTRADIOL
TEVA PHARMS USAANDA 2104882018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB
ESTRADIOL
ENCUBEANDA 2097672018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB
ESTRADIOL
PADAGIS ISRAELANDA 2101942018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB
ESTRADIOL
MYLANANDA 2087882017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB
ESTRADIOL
TEVA PHARMS USAANDA 2063882017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MCG TABLET VAGINAL Rx AB
ESTRADIOL
AMNEAL PHARMSANDA 2052562015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MCG TABLET VAGINAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	CREAM	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MCG	TABLET	VAGINAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MCG	TABLET	VAGINAL	Rx	AB

ESTRADIOL

MYLAN TECHNOLOGIESANDA 20167520145 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.0375MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.05MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.075MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1
0.1MG/24HR	SYSTEM	TRANSDERMAL	Rx	AB1

ESTRADIOL

MYLAN TECHNOLOGIESANDA 07518220056 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.075MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.025MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.0375MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.06MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2
0.05MG/24HR	FILM, EXTENDED RELEASE	TRANSDERMAL	Rx	AB2

ESTRADIOL
USL PHARMAANDA 04029720023 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
INNOFEM
NOVO NORDISK INCANDA 04031219993 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
ESTRADIOL
PHARMOBEDIENTANDA 04032619993 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
ESTRADIOL
EPIC PHARMA LLCANDA 04027519983 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
ESTRADIOL
LANNETT CO INCANDA 04013819983 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
GYNODIOL
DURAMED PHARMS BARRANDA 04021219974 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
1.5MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
ESTRADIOL
BARR LABS INCANDA 04019719973 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
ESTRADIOL
RUBICON RESEARCHANDA 04011419963 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
0.5MG TABLET ORAL Discontinued —
ESTRACE
BRISTOL MYERS SQUIBBANDA 0812951993
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
ESTRACERLDRS
ABBVIEANDA 0860691984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% CREAM VAGINAL Rx AB
ESTRACERLD
BRISTOL MYERS SQUIBBANDA 084499—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
ESTRACERLD
BRISTOL MYERS SQUIBBANDA 084500—
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

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Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9730900	Jul 10, 2028	in 1 yr 11 mo	ProductU-2086
9833419	Jul 10, 2028	in 1 yr 11 mo	Product
9724310	Jul 10, 2028	in 1 yr 11 mo	SubstanceProduct
8231906	Jul 04, 2030	in 3 yr 11 mo	SubstanceProduct
10258630	Nov 21, 2032	in 6 yr 4 mo	U-2316
10398708	Nov 21, 2032	in 6 yr 4 mo	U-2317
10471072	Nov 21, 2032	in 6 yr 4 mo	U-2317
10537581	Nov 21, 2032	in 6 yr 4 mo	ProductU-2316
11246875	Nov 21, 2032	in 6 yr 4 mo	U-2316
11241445	Nov 21, 2032	in 6 yr 4 mo	U-2316
10668082	Nov 21, 2032	in 6 yr 4 mo	U-2317
10568891	Nov 21, 2032	in 6 yr 4 mo	U-2316
9180091	Nov 21, 2032	in 6 yr 4 mo	ProductU-2317
10835487	Nov 21, 2032	in 6 yr 4 mo	U-2316
10888516	Nov 21, 2032	in 6 yr 4 mo	U-2316
11351182	Nov 21, 2032	in 6 yr 4 mo	U-2316
11065197	Nov 21, 2032	in 6 yr 4 mo	Product
9289382	Nov 21, 2032	in 6 yr 4 mo	Product
10806697	Nov 21, 2032	in 6 yr 4 mo	Product
11123283	Nov 21, 2032	in 6 yr 4 mo	Product
11304959	Nov 21, 2032	in 6 yr 4 mo	Product
11116717	Nov 21, 2032	in 6 yr 4 mo	Product
11497709	Nov 21, 2032	in 6 yr 4 mo	U-2316
11266661	Feb 02, 2034	in 7 yr 7 mo	U-2316

Approval history

FDA approval span

First approval

Jan 31, 1984

43 yr 2 mo ago

Most recent approval

May 11, 2026

3 mo ago

Approvals span 1984–2026 across 58 FDA applications.

Brand (NDA) 1729%

Generic (ANDA) 4171%

Estradiol: 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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