RIZAFILM (rizatriptan benzoate)
RizaFilm is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks.
Details
- Status
- Prescription
- First Approved
- 2023-04-14
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- FILM
RIZAFILM Approval History
What RIZAFILM Treats
2 FDA approvalsOriginally approved for its first indication in 2023 . Covers 2 distinct patient populations.
- Other (2)
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06473597 | 2023-12-20 | Ph 4 | recruiting | A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache |
| NCT00812006 results posted | 0462-085 2008_597 | Ph 3 | completed | A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis |
| NCT01004263 results posted | 0462-086 2009_680 | Ph 3 | completed | A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RIZAFILM FDA Label Details
Indications & Usage
FDA Label (PDF)RizaFilm™ is indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age. Limitations of Use RizaFilm should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with RizaFilm, the diagnosis of migraine should be reconsidered before RizaFilm is administered to treat any subsequent attacks. RizaFilm is not indicated for the preventive treatment of migraine. Safety and effectiveness of RizaFilm have not been established for cluster headache. RizaFil...
RIZAFILM Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for RIZAFILM
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.