FDA Orange Book · active-ingredient family
Ethinyl estradiol; etonogestrel
Ethinyl estradiol; etonogestrel: 1 brand, 5 generics; first approved Oct 03, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
5
Listed patents
0
Presentations
6
Brand (NDA) products
Originator applications
- ORGANON USA ORGANONNDA 0211872001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL Rx AB
Generic (ANDA) products (5)
Abbreviated applications
- XIROMEDANDA 2111572023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL Rx AB - DR REDDYS LABS SAANDA 2113282022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL Rx AB - DR REDDYS LABS SAANDA 2075772021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL Discontinued — - ETHINYL ESTRADIOL; ETONOGESTRELTEVA PHARMS USA INCANDA 2043052021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL Rx AB - AMNEALANDA 2108302019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.015MG/24HR;0.12MG/24HR RING VAGINAL 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
25 yr 3 mo ago
Most recent approval
3 yr 2 mo ago
Approvals span 2001–2023 across 6 FDA applications.
Brand (NDA) 117%
Generic (ANDA) 583%
Ethinyl estradiol; etonogestrel: 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.
