FDA Orange Book · active-ingredient family
Eplerenone
Eplerenone is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INSPRA · NDA 021437
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INSPRARLD×3 | UPJOHN | NDA 021437 | AB | Sep 27, 2002 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EPLERENONE×2 | ANNORA PHARMA | ANDA 213812 | AB | Jun 02, 2023 | |
| EPLERENONE×2 | RISING | ANDA 214663 | AB | Mar 23, 2022 | |
| EPLERENONE×2 | WESTMINSTER PHARMS | ANDA 207842 | AB | Oct 25, 2021 | |
| EPLERENONE×2 | ADAPTIS | ANDA 212765 | AB | Aug 10, 2020 | |
| EPLERENONE×2 | BRECKENRIDGE | ANDA 208283 | AB | Sep 14, 2018 | |
| EPLERENONE×2 | ACCORD HLTHCARE | ANDA 206922 | AB | Jul 13, 2017 | |
| EPLERENONE×2 | INNOGENIX | ANDA 203896 | — | Feb 02, 2017 | |
| EPLERENONE×2 | SANDOZ | ANDA 078510 | AB | Aug 01, 2008 | |
| EPLERENONE×2 | CHARTWELL RX | ANDA 078482 | AB | Jul 30, 2008 |
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.
Eplerenone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
