Is there a generic for Desogestrel; ethinyl estradiol?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Desogestrel; ethinyl estradiol, referencing the brand CYCLESSA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Desogestrel; ethinyl estradiol?

CYCLESSA (NDA 021090, ASPEN GLOBAL INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Desogestrel; ethinyl estradiol are approved?

Desogestrel; ethinyl estradiol is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Desogestrel; ethinyl estradiol

Desogestrel; ethinyl estradiol: 4 brands, 23 generics; first approved Dec 10, 1992; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 23 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

CYCLESSARLDRS

ASPEN GLOBAL INCNDA 0210902000

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET	ORAL-28	Rx	AB

MIRCETTERLD

TEVA BRANDED PHARMNDA 0207131998

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

ORTHO-CEPTRLD

JANSSEN PHARMSNDA 02030119922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-21	Discontinued	—
0.15MG;0.03MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL-28	Discontinued	—

DESOGEN

ORGANON USA INCNDA 02007119922 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-21	Discontinued	—
0.15MG;0.03MG	TABLET	ORAL-28	Discontinued	—

Abbreviated applications

Generic (ANDA) products (23)

DESOGESTREL AND ETHINYL ESTRADIOL

ANNORA PHARMAANDA 2197612026

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

AVERI

AVION PHARMSANDA 21893320252 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-21	Rx	—
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

DESOGESTREL AND ETHINYL ESTRADIOL

NAARI PTEANDA 2070672018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

DESOGESTREL AND ETHINYL ESTRADIOL

NAARI PTEANDA 2091702017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

KALLIGA

AUROBINDO PHARMAANDA 2070812017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

SIMLIYA

AUROBINDO PHARMAANDA 2068532017

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

VOLNEA

XIROMEDANDA 2026892016

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

BEKYREE

LUPINANDA 2022262015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

ISIBLOOM

XIROMEDANDA 2027892015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

DESOGESTREL AND ETHINYL ESTRADIOL

XIROMEDANDA 2020852015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Discontinued	—

KIMIDESS

PH HEALTHANDA 0766812015

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Discontinued	—

DESOGESTREL AND ETHINYL ESTRADIOL

XIROMEDANDA 2022962013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

PIMTREA

NOVAST LABSANDA 0912472013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

DESOGESTREL AND ETHINYL ESTRADIOL

NOVAST LABSANDA 0912342013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

ENSKYCE

LUPIN LTDANDA 2018872013

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

VIORELE

GLENMARK PHARMS LTDANDA 0913462012

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

EMOQUETTE

PH HEALTHANDA 0766752011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Discontinued	—

DESOGESTREL AND ETHINYL ESTRADIOL

DR REDDYS LABS SAANDA 0769162008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Discontinued	—

DESOGESTREL AND ETHINYL ESTRADIOL

DR REDDYS LABS SAANDA 0771822006

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET	ORAL-28	Discontinued	—

DESOGESTREL AND ETHINYL ESTRADIOL

WATSON LABSANDA 0769152005

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

VELIVET

DURAMED PHARMS BARRANDA 0764552004

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG	TABLET	ORAL-28	Rx	AB

KARIVARS

BARRANDA 0758632002

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG,N/A;0.02MG,0.01MG	TABLET	ORAL-28	Rx	AB

DESOGESTREL AND ETHINYL ESTRADIOL

DURAMED PHARMS BARRANDA 07525619992 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15MG;0.03MG	TABLET	ORAL-21	Discontinued	—
0.15MG;0.03MG	TABLET	ORAL-28	Rx	AB

Orange Book patent file

Listed patents

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.

FDA approval span

Approval history

First approval

Dec 10, 1992

34 yr 1 mo ago

Most recent approval

Mar 18, 2026

4 mo ago

Approvals span 1992–2026 across 27 FDA applications.

Brand (NDA) 415%

Generic (ANDA) 2385%

Desogestrel; ethinyl 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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