BINOSTO (alendronate sodium)
Binosto is an effervescent tablet used to help postmenopausal women and men who have osteoporosis. It helps patients by increasing bone mass and reducing the risk of fractures, specifically in the hip and spine. Because the ideal length of therapy is not yet determined, clinicians should re-evaluate the need for continued use every few years, especially for those at low risk for bone breaks.
How BINOSTO Works
This medication works by concentrating at sites of bone resorption and inhibiting the activity of osteoclasts, the cells responsible for breaking down bone. By slowing this process, the drug allows bone formation to exceed bone resorption, which leads to progressive gains in bone mass.
Details
- Status
- Prescription
- First Approved
- 2012-03-12
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET, EFFERVESCENT
BINOSTO Approval History
What BINOSTO Treats
1 indicationsBINOSTO is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoporosis
BINOSTO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to BINOSTO
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06016634 | 1693339 5K23HL148310, 2020095 | Ph 2 | recruiting | Alendronate for Osteonecrosis in Adults With Sickle Cell Disease |
| NCT05493761 OsteoNAFLD | 88235 | Ph 4 | active not recruiting | Effect of Anti-osteoporotic Medications on Nonalcoholic Fatty Liver Disease |
| NCT04704947 | osteoprosis | Ph 3 | recruiting | Clinical Study Evaluating Beta Blockers Use and Fracture Risk in Patients With Primary Osteoporosis |
| NCT02795546 | PMVIDS/PER/0029/2014 | Ph 4 | completed | Effect of Alendronate With β - TCP Bone Substitute in Surgical Therapy of Periodontal Intra-osseous Defects. |
| NCT00996801 results posted | 5442-012 2009-014729-18, CTRI/2010/091/000258 | Ph 2 | completed | MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012) |
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.
BINOSTO FDA Label Details
Indications & Usage
FDA Label (PDF)BINOSTO is indicated for the treatment of Osteoporosis.
BINOSTO Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for BINOSTO
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 1 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • 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.