FDA Orange Book · active-ingredient family
Spironolactone
Spironolactone is approved as 2 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAROSPIR · NDA 209478
2
Brand (NDA)
27
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAROSPIRRLD | CMP DEV LLC | NDA 209478 | AB | Aug 04, 2017 | |
| ALDACTONERLD×3 | PFIZER | NDA 012151 | AB | Dec 30, 1983 |
Generic (ANDA) products (27)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPIRONOLACTONE×3 | ANNORA PHARMA | ANDA 217761 | AB | Jul 25, 2025 | |
| SPIRONOLACTONE | HETERO LABS LTD III | ANDA 218085 | AB | Feb 21, 2025 | |
| SPIRONOLACTONE×3 | GRAVITI PHARMS | ANDA 219494 | AB | Jan 23, 2025 | |
| SPIRONOLACTONE | AMNEAL | ANDA 215572 | AB | Sep 05, 2023 | |
| SPIRONOLACTONE×3 | ZYDUS PHARMS | ANDA 205936 | AB | Jul 18, 2018 | |
| SPIRONOLACTONE×3 | ACCORD HLTHCARE | ANDA 203512 | AB | Sep 19, 2016 | |
| SPIRONOLACTONE×3 | JUBILANT GENERICS | ANDA 203253 | AB | Apr 23, 2014 | |
| SPIRONOLACTONE×3 | AUROBINDO PHARMA | ANDA 202187 | AB | Mar 06, 2014 | |
| SPIRONOLACTONE×3 | AMNEAL PHARMS | ANDA 091426 | AB | Jul 02, 2010 | |
| SPIRONOLACTONE×3 | OXFORD PHARMS | ANDA 040750 | AB | Aug 29, 2006 | |
| SPIRONOLACTONE×3 | ACTAVIS ELIZABETH | ANDA 040353 | — | Mar 15, 2006 | |
| SPIRONOLACTONE×3 | MYLAN | ANDA 040424 | AB | Aug 20, 2001 | |
| SPIRONOLACTONE | SUPERPHARM | ANDA 089364 | — | Nov 07, 1986 | |
| SPIRONOLACTONE×3 | SUN PHARM INDUSTRIES | ANDA 089424 | AB | Jul 23, 1986 | |
| SPIRONOLACTONE | PUREPAC PHARM | ANDA 087998 | — | Oct 14, 1983 | |
| SPIRONOLACTONE | PUREPAC PHARM | ANDA 088053 | — | Aug 25, 1983 | |
| SPIRONOLACTONE | WARNER CHILCOTT | ANDA 087952 | — | Nov 18, 1982 | |
| SPIRONOLACTONE | ASCOT | ANDA 087687 | — | Oct 20, 1982 | |
| SPIRONOLACTONE | WATSON LABS | ANDA 086898 | — | Mar 02, 1982 | |
| SPIRONOLACTONE | VANGARD | ANDA 087648 | — | Feb 01, 1982 | |
| SPIRONOLACTONE | CHARTWELL RX | ANDA 086809 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | IVAX PHARMS | ANDA 087108 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | LEDERLE | ANDA 087634 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | MUTUAL PHARM | ANDA 087265 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | PHARMOBEDIENT | ANDA 087086 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | UPSHER SMITH | ANDA 087554 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE | WATSON LABS | ANDA 087078 | — | Approved Prior to Jan 1, 1982 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9757394 | Oct 28, 2036 | in 10 yr 6 mo | ProductU-2109 |
| 11395828 | Oct 28, 2036 | in 10 yr 6 mo | U-2109 |
| 10888570 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 11389461 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10660907 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10624906 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 10493083 | Oct 28, 2036 | in 10 yr 6 mo | Product |
| 11491166 | Oct 28, 2036 | in 10 yr 6 mo | Product |
Spironolactone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
