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DARIFENACIN HYDROBROMIDE
Darifenacin hydrobromide is a marketed drug primarily indicated for overactive bladder. The key composition patent expires in 2028, providing a period of market exclusivity. The primary risk is the potential increase in competition post-patent expiry.
At a glance
| Generic name | DARIFENACIN HYDROBROMIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2004 |
Approved indications
- Overactive Bladder
Common side effects
- Dry Mouth
- Constipation
- Dyspepsia
- Abdominal Pain
- Urinary Tract Infection
- Asthenia
- Dry Eyes
- Dizziness
- Nausea
- Diarrhea
- Abnormal Vision
- Accidental Injury
Serious adverse events
- Urinary Retention
- Constipation
Drug interactions
- CYP2D6 substrates (e.g., flecainide, thioridazine, tricyclic antidepressants)
- Other anticholinergic agents
- Potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, nefazadone)
- Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil)
- CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine, duloxetine)
- Midazolam
- Combination oral contraceptives (levonorgestrel and ethinyl estradiol)
- Warfarin
- Digoxin
Key clinical trials
- Efficacy and Tolerability of Tadalafil Versus Darifenacin in Management of Ureteric Stent-Related LUTS (PHASE1, PHASE2)
- A Study to Assess the Safety, Tolerability, and Pharmacology of Darifenacin in Patients With ALS (PHASE2)
- Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis (EARLY_PHASE1)
- Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania
- A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)
- Darifenacin x Parasacral Transcutaneous Electric Nerve Stimulation for OAB in Patients Infected With Human T-Lymphotropic Virus 1 (PHASE4)
- A Two-week Open-label Pharmacodynamic and Pharmacokinetic Study of Multiple Doses of a Darifenacin Liquid Oral Suspension in Children (2 - 15 Years) With Neurogenic Detrusor Overactivity (PHASE2)
- A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DARIFENACIN HYDROBROMIDE CI brief — competitive landscape report
- DARIFENACIN HYDROBROMIDE updates RSS · CI watch RSS