Is there a generic for Ethinyl estradiol; levonorgestrel?

Yes. The FDA Orange Book lists 61 approved generic (ANDA) applications for Ethinyl estradiol; levonorgestrel, referencing the brand TYBLUME. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ethinyl estradiol; levonorgestrel?

TYBLUME (NDA 209405, EXELTIS USA INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ethinyl estradiol; levonorgestrel?

The Orange Book lists 6 patents against Ethinyl estradiol; levonorgestrel products, with the earliest listed expiry in 2027. 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 Ethinyl estradiol; levonorgestrel are approved?

Ethinyl estradiol; levonorgestrel is approved in the following dosage forms: system, tablet.

FDA Orange Book · active-ingredient family

Ethinyl estradiol; levonorgestrel

Ethinyl estradiol; levonorgestrel: 15 brands, 61 generics; first approved May 10, 1982; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 61 ANDA applications approved.

Earliest patent expiry Jun 01, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jun 01, 2027

in 11 mo

Originator applications

Brand (NDA) products

TYBLUMERLDRS

EXELTIS USA INCNDA 2094052020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG	TABLET	ORAL	Rx	—

TWIRLARLDRS

AGILENDA 2040172020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG/24HR;0.12MG/24HR	SYSTEM	TRANSDERMAL	Rx	—

BALCOLTRARLDRS

AVION PHARMSNDA 2086122018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG	TABLET	ORAL	Rx	AB3

QUARTETTERLDRS

TEVA BRANDED PHARMNDA 2040612013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A	TABLET	ORAL	Rx	AB

LYBRELRLD

WYETH PHARMS INCNDA 0218642007

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.09MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—

SEASONIQUERLDRS

TEVA BRANDED PHARMNDA 0218402006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG,0.01MG;0.15MG,N/A	TABLET	ORAL	Rx	AB

SEASONALERLDRS

TEVA BRANDED PHARMNDA 0215442003

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG;0.15MG	TABLET	ORAL	Rx	AB

LEVLITERLD

BAYER HLTHCARENDA 02086019982 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-21	Discontinued	—
0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

ALESSERLD

CADENCE HEALTHNDA 02068319972 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-21	Discontinued	—
0.02MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

TRIPHASIL-21RLD

WYETH PHARMSNDA 0191921984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-21	Discontinued	—

TRIPHASIL-28RLD

WYETH PHARMS INCNDA 0191901984

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

NORDETTE-28RLD

TEVA BRANDED PHARMNDA 0187821982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG;0.15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

LOSEASONIQUE

TEVA BRANDED PHARMNDA 0222622008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG,0.1MG;0.01MG,N/A	TABLET	ORAL	Rx	AB

PREVEN EMERGENCY CONTRACEPTIVE KIT

TEVA BRANDED PHARMNDA 0209461998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.05MG;0.25MG	TABLET	ORAL	Discontinued	—

NORDETTE-21

TEVA BRANDED PHARMNDA 0186681982

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03MG;0.15MG	TABLET	ORAL-21	Discontinued	—

Abbreviated applications

Generic (ANDA) products (61)

MINZOYA

LUPINANDA 2170872024

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG	TABLET	ORAL	Rx	AB3

LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

XIROMEDANDA 2146402023

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG;0.1MG	TABLET	ORAL	Rx	AB3

Patent	Expires	In	Type
7838042	Jun 01, 2027	in 11 mo	SubstanceU-3251
8747888	Jul 10, 2028	in 2 yr	Product
9050348	Jul 10, 2028	in 2 yr	Product
8246978	Aug 26, 2028	in 2 yr 2 mo	Product
7855190	Dec 05, 2028	in 2 yr 5 mo	U-1
8415332	Mar 11, 2029	in 2 yr 8 mo	Product

Ethinyl estradiol; levonorgestrel

Brand (NDA) products

Generic (ANDA) products (61)

Patent & exclusivity timeline

Listed patents

Listed patents (6)

Approval history