FDA Orange Book · active-ingredient family
Ethinyl estradiol; etonogestrel
Ethinyl estradiol; etonogestrel is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NUVARING · NDA 021187
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · ring
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NUVARINGRLD | ORGANON USA ORGANON | NDA 021187 | AB | Oct 03, 2001 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENILLORING | XIROMED | ANDA 211157 | AB | Jun 29, 2023 | |
| HALOETTE | DR REDDYS LABS SA | ANDA 211328 | AB | Aug 05, 2022 | |
| VERARING | DR REDDYS LABS SA | ANDA 207577 | — | Dec 09, 2021 | |
| ETHINYL ESTRADIOL; ETONOGESTREL | TEVA PHARMS USA INC | ANDA 204305 | AB | Jan 13, 2021 | |
| ELURYNG | AMNEAL | ANDA 210830 | AB | Dec 11, 2019 |
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.
Ethinyl estradiol; etonogestrel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
