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FINGOLIMOD HYDROCHLORIDE
Fingolimod Hydrochloride is a marketed drug primarily indicated for relapsing forms of multiple sclerosis. Its key strength lies in its established market presence, supported by a key composition patent expiring in 2028. The primary risk is the eventual loss of exclusivity post-patent expiry, which could lead to increased competition from generics.
At a glance
| Generic name | FINGOLIMOD HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2010 |
Approved indications
- Relapsing Forms of Multiple Sclerosis
Common side effects
- Headache
- Liver transaminase elevation
- Diarrhea
- Cough
- Influenza
- Sinusitis
- Back pain
- Abdominal pain
- Pain in extremity
- Serum transaminase elevations
- Basal cell carcinoma
- Seizure
Serious adverse events
- Ischemic stroke
- Hemorrhagic stroke
- Peripheral arterial occlusive disease
- Status epilepticus
- Seizure
Key clinical trials
- A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
- Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis (PHASE4)
- Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (PHASE2, PHASE3)
- Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
- Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis (PHASE3)
- A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (PHASE3)
- Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients (PHASE4)
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:
- FINGOLIMOD HYDROCHLORIDE CI brief — competitive landscape report
- FINGOLIMOD HYDROCHLORIDE updates RSS · CI watch RSS