IBANDRONATE SODIUM · ORBION PHARMS
Ibandronate sodium helps postmenopausal women manage bone health by treating and preventing osteoporosis. It works to increase bone mineral density, which helps reduce the occurrence of vertebral fractures. Because the ideal length of treatment is not yet known, healthcare providers should regularly re-evaluate whether a patient needs to continue therapy, particularly after three to five years of use.
How IBANDRONATE SODIUM Works
This medication works by binding to hydroxyapatite in the bone matrix to inhibit osteoclast activity and reduce bone turnover. By slowing the rate of bone resorption, it helps postmenopausal women achieve a net gain in bone mass.
Details
- Status
- Prescription
- First Approved
- 2003-05-16
- Routes
- ORAL, INTRAVENOUS, INJECTION
- Dosage Forms
- TABLET, INJECTABLE
Companies
IBANDRONATE SODIUM Approval History
What IBANDRONATE SODIUM Treats
1 indicationsIBANDRONATE SODIUM is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
IBANDRONATE SODIUM 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.
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01627886 | BA0859144-01 | Ph 1 | completed | Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition |
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.
IBANDRONATE SODIUM FDA Label Details
Indications & Usage
FDA Label (PDF)Ibandronate sodium tablet is a bisphosphonate indicated for the treatment and prevention of postmenopausal osteoporosis. . Limitations of Use The optimal duration of use has not been determined. For patients at low -risk for fracture, consider drug discontinuation after 3 to 5 years of use. . 1.1 Treatment and Prevention of Postmenopausal Osteoporosis Ibandronate sodium tablets are indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandronate sodium increases bone mineral density (BMD) and reduces the incidence of vertebral fractures. 1.2 Important Limitations...
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BONIVA
Full clinical data, patents, trials, and competitive landscape for ibandronate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.