FDA Orange Book · active-ingredient family
Desogestrel; ethinyl estradiol
Desogestrel; ethinyl estradiol: 4 brands, 24 generics; first approved Dec 10, 1992; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 24 ANDA applications approved.
Brands (NDA)
4
Generics (ANDA)
24
Listed patents
0
Presentations
32
Brand (NDA) products
Originator applications
- 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 - MIRCETTERLDTEVA BRANDED PHARMNDA 0207131998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG,N/A;0.02MG,0.01MG TABLET ORAL-28 Discontinued — - ORTHO-CEPTRLDJANSSEN PHARMSNDA 02030119922 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 — - 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 —
Generic (ANDA) products (24)
Abbreviated applications
- ANNORA PHARMAANDA 2196702026
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 - ANNORA PHARMAANDA 2197612026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - 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 - NAARI PTEANDA 2070672018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - 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 - AUROBINDO PHARMAANDA 2070812017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - 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 - 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 - 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 - XIROMEDANDA 2027892015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - XIROMEDANDA 2020852015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Discontinued — - 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 — - 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 - 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 - NOVAST LABSANDA 0912342013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - LUPIN LTDANDA 2018872013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - 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 - PH HEALTHANDA 0766752011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Discontinued — - 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 — - 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 — - WATSON LABSANDA 0769152005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.15MG;0.03MG TABLET ORAL-28 Rx AB - 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 - KARIVARSBARRANDA 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 - 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
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
34 yr 2 mo ago
Most recent approval
28 d ago
Approvals span 1992–2026 across 28 FDA applications.
Brand (NDA) 414%
Generic (ANDA) 2486%
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.
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.
