FDA Orange Book · active-ingredient family
Silodosin
Silodosin is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RAPAFLO · NDA 022206
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RAPAFLORLD×2 | ABBVIE | NDA 022206 | — | Oct 08, 2008 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SILODOSIN×2 | TORRENT | ANDA 210396 | — | Feb 10, 2025 | |
| SILODOSIN×2 | ZYDUS PHARMS | ANDA 204816 | — | Dec 08, 2022 | |
| SILODOSIN×2 | PRINSTON INC | ANDA 209029 | AB | Jan 04, 2022 | |
| SILODOSIN×2 | CREEKWOOD PHARMS | ANDA 213230 | AB | Jan 03, 2022 | |
| SILODOSIN×2 | HETERO LABS LTD V | ANDA 204793 | AB | Feb 14, 2020 | |
| SILODOSIN×2 | ALEMBIC | ANDA 211731 | — | Nov 22, 2019 | |
| SILODOSIN×2 | AUROBINDO PHARMA LTD | ANDA 210626 | AB | Dec 10, 2018 | |
| SILODOSIN×2 | AJANTA PHARMA LTD | ANDA 211060 | AB | Dec 03, 2018 | |
| SILODOSIN×2 | AMNEAL PHARMS CO | ANDA 209745 | AB | Dec 03, 2018 | |
| SILODOSIN×2 | LUPIN | ANDA 206541 | AB | Dec 03, 2018 | |
| SILODOSIN×2 | MACLEODS PHARMS LTD | ANDA 211166 | AB | Dec 03, 2018 | |
| SILODOSIN×2 | MSN | ANDA 210687 | AB | Dec 03, 2018 | |
| SILODOSIN×2 | CHARTWELL RX | ANDA 204726 | AB | Mar 31, 2017 |
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.
Silodosin — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
