Sold as Rapaflo. Every FDA application for this active ingredient: 1 branded and 13 generic.
As of Nov 14, 2026, FDA lists 14 applications for Silodosin (sold as Rapaflo), first approved Oct 8, 2008, with 0 new uses approved and 0 published complete response letters.
| Silodosin | Part D | $23.9M | -6% | 88,427 |
| Rapaflo | Part D | $823K | -56% | 629 |
| A Multicenter Randomized Cross-Over Study Evaluating the Efficacy and Safety of Silodosin in Adult Women With Voiding DysfunctionVoiding Dysfunction, Female LUTS · Jaber Al Ahmad Al Sabah Hospital | Phase 2 | Not yet recruiting | Sep 16, 2026 |
| Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic ObstructionBPH (Benign Prostatic Hyperplasia) · Mansoura University | Phase 4 | Active, not recruiting | Sep 11, 2026 |
| Pupil Size and Choroidal Thickness Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia PatientsBenign Prostatic Hyperplasia, Silodosin · Mohsen Pourazizi | Phase 4 | Not yet recruiting | Aug 3, 2026 |
| Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia PatientsBenign Prostatic Hyperplasia, Tamsulosin · Mohsen Pourazizi | Phase 4 | Not yet recruiting | Aug 3, 2026 |
| Tamsulosin Dose Escalation or Silodosin Switch Before Trial Without Catheter in BPH-Related Acute Urinary RetentionAcute Urinary Retention, Benign Prostatic Hyperplasia · Beni-Suef University | Phase 4 | Recruiting | Jun 16, 2026 |
| Silodosin for Urinary Symptoms in Female Patients With Multiple SclerosisMultiple Sclerosis, Lower Urinary Track Symptoms · Atlantic Health System | Phase 4 | Recruiting | May 29, 2026 |
| Silodosin vs Tamsulosin for LUTS Due to BPH: A Randomized Crossover TrialBenign Prostatic Hyperplasia, Lower Urinary Tract Symptoms · Ain Shams University | Phase 4 | Not yet recruiting | Mar 12, 2026 |
| Sildosin as a Male Contraceptive Non HormonalContraception Use · Benha University | Phase 1 | Not yet recruiting | Sep 26, 2025 |
| Oct 8, 2008 | RapafloNDA 22206 · New molecular entity | Abbvie | 8 | Discontinued |
| Mar 31, 2017 | SilodosinANDA 204726 | Chartwell Rx | 1 | Marketed |
| Dec 3, 2018 | SilodosinANDA 206541 | Lupin | 1 | Marketed |
| Dec 3, 2018 | SilodosinANDA 209745 | Amneal Pharms Co | 1 | Marketed |
| Dec 3, 2018 | SilodosinANDA 210687 | Msn | 1 | Marketed |
| Dec 3, 2018 | SilodosinANDA 211060 | Ajanta Pharma Ltd | 1 | Marketed |
| Dec 3, 2018 | SilodosinANDA 211166 | Macleods Pharms | 1 | Marketed |
| Dec 10, 2018 | SilodosinANDA 210626 | Aurobindo Pharma Ltd | 1 | Marketed |
| Nov 22, 2019 | SilodosinANDA 211731 | Alembic | 1 | Discontinued |
| Feb 14, 2020 | SilodosinANDA 204793 | Hetero Labs Ltd V | 1 | Marketed |
| Jan 3, 2022 | SilodosinANDA 213230 | Pharmazone | 0 | Marketed |
| Jan 4, 2022 | SilodosinANDA 209029 | Prinston | 0 | Marketed |
| Dec 8, 2022 | SilodosinANDA 204816 | Zydus Pharms | 0 | Discontinued |
| Feb 10, 2025 | SilodosinANDA 210396 | Torrent | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Abbvie
Lupin
Alembic
Zydus Pharms