FDA Orange Book · active-ingredient family
Ethinyl estradiol; norethindrone acetate
Ethinyl estradiol; norethindrone acetate: 15 brands, 60 generics; first approved Oct 09, 1996; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 60 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
15
Generics (ANDA)
60
Listed patents
2
Next patent expiry
Feb 02, 2029
in 2 yr 6 mo
Brand (NDA) products
Originator applications
- MILLICENT MFG PRNDA 2187182024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET, ORALLY DISINTEGRATING ORAL Rx — - APILNDA 2046542013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG,0.01MG,N/A;1MG,N/A,N/A TABLET, CHEWABLE, TABLET ORAL Discontinued — - APILNDA 2036672013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - APILNDA 2044262013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Rx AB - APILNDA 0225012010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG,0.01MG;1MG,N/A TABLET ORAL Rx AB - TEVA BRANDED PHARMNDA 0218712006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - FEMHRTRLDAPILNDA 02106520052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0025MG;0.5MG TABLET ORAL Discontinued — 0.005MG;1MG TABLET ORAL Discontinued — - ESTROSTEP 21RLDAPILNDA 02013019962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-21 Discontinued — 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-28 Discontinued — - TEVA BRANDED PHARMNDA 017875—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Discontinued — - TEVA BRANDED PHARMNDA 017876—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Discontinued — - TEVA BRANDED PHARMNDA 017355—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Discontinued — - TEVA BRANDED PHARMNDA 017354—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Discontinued — - PARKE DAVISNDA 016749—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG;1MG TABLET ORAL-21 Discontinued — - PARKE DAVISNDA 016852—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG;2.5MG TABLET ORAL-21 Discontinued — - PARKE DAVISNDA 016723—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG;1MG TABLET ORAL-28 Discontinued —
Generic (ANDA) products (60)
Abbreviated applications
- TEVA PHARMS INCANDA 2193242026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG,0.01MG;1MG,N/A TABLET ORAL Rx AB - AUROBINDO PHARMAANDA 2165582023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - GLENMARK PHARMS LTDANDA 2134182022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Rx AB - DR REDDYS LABS SAANDA 2139012022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Discontinued — - AMNEAL PHARMSANDA 2142922021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Discontinued — - WILSHIRE PHARMS INCANDA 2127062020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Rx AB - XIROMEDANDA 2133172020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG CAPSULE ORAL Rx AB - NOVAST LABSANDA 2029622020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-28 Rx AB - TEVA PHARMS USA INCANDA 2100872020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - XIROMEDANDA 2096092018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - XIROMEDANDA 2050692018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-28 Rx AB - GLENMARK SPECLTANDA 2092972018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Rx AB - GLENMARK SPECLTANDA 2090312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - APOTEXANDA 2086392018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - GLENMARK PHARMS LTDANDA 2103692017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - GLENMARK PHARMS LTDANDA 2065972017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - GLENMARK PHARMS LTDANDA 2048472017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - XIROMEDANDA 2061202017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - AMNEAL PHARMSANDA 2075142017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - AUROBINDO PHARMAANDA 2075812017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Rx AB - AUROBINDO PHARMAANDA 2075062017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Rx AB - AUROBINDO PHARMAANDA 2075052017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - AUROBINDO PHARMAANDA 2075042017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - AUROBINDO PHARMAANDA 2075802017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - XIROMEDANDA 2072602017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0025MG;0.5MG TABLET ORAL Discontinued — - XIROMEDANDA 2072592016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005MG;1MG TABLET ORAL Discontinued — - NOVAST LABSANDA 20343520162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005MG;1MG TABLET ORAL Rx AB 0.0025MG;0.5MG TABLET ORAL Rx AB - XIROMEDANDA 2050492016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.01MG,0.01MG;1MG,N/A TABLET ORAL Discontinued — - LUPINANDA 2062872016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - GLENMARK PHARMS LTDANDA 2069692016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Rx AB - LUPINANDA 20421320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0025MG;0.5MG TABLET ORAL Rx AB 0.005MG;1MG TABLET ORAL Rx AB - LUPINANDA 2015852015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - LUPINANDA 2015842015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - LUPINANDA 0913982015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - GLENMARK PHARMS LTDANDA 20303820152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.0025MG;0.5MG TABLET ORAL Rx AB 0.005MG;1MG TABLET ORAL Rx AB - XIROMEDANDA 2027412015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - XIROMEDANDA 2027702015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Rx AB - NOVAST LABSANDA 2029942015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - PH HEALTHANDA 0902932014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - BARR LABSANDA 0909382014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Rx AB - XIROMEDANDA 2027422014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - NOVAST LABSANDA 2029962014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Rx AB - NOVAST LABSANDA 2029952013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Rx AB - XIROMEDANDA 2027722013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - XIROMEDANDA 2027712013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Rx AB - NOVAST LABSANDA 0914542013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - NOVAST LABSANDA 0914532013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - PH HEALTHANDA 07707520122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Discontinued — 0.03MG;1.5MG TABLET ORAL-21 Discontinued — - PH HEALTHANDA 07707720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Discontinued — 0.02MG;1MG TABLET ORAL-21 Discontinued — - DR REDDYS LABS SAANDA 0766292010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-28 Discontinued — - BARR LABS INCANDA 0762212009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.005MG;1MG TABLET ORAL Rx AB - AMNEAL PHARMSANDA 0782672009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL Discontinued — - BARRANDA 0764052007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-21 Discontinued — - BARRANDA 0761052007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG TABLET ORAL-28 Rx AB - BARRANDA 0760642003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Rx AB - BARRANDA 0760812003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Rx AB - DR REDDYS LABS SAANDA 07554820032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-28 Discontinued — 0.03MG;1.5MG TABLET ORAL-21 Discontinued — - DR REDDYS LABS SAANDA 07564720032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-28 Discontinued — 0.02MG;1MG TABLET ORAL-21 Discontinued — - BARRANDA 0763812003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.03MG;1.5MG TABLET ORAL-21 Rx AB - BARR LABSANDA 0763802003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG;1MG TABLET ORAL-21 Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
in 1 yr
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7704984 | in 2 yr 6 mo | U-1 | |
| 12178824 | in 15 yr 1 mo | Product |
Approval history
FDA approval span
First approval
30 yr 3 mo ago
Most recent approval
1 mo ago
Approvals span 1996–2026 across 75 FDA applications.
Brand (NDA) 1520%
Generic (ANDA) 6080%
Ethinyl estradiol; norethindrone acetate: 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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