NDAORALTABLET
Approved
May 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
3/8 — Basic
BONIVA (ibandronate sodium) by Roche is hydroxyapatite, which is part of the mineral matrix of bone. First approved in 2003.
Drug data last refreshed 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BONIVA (ibandronate sodium) is a bisphosphonate small-molecule oral tablet approved in 2003 for treating postmenopausal osteoporosis. It works by inhibiting osteoclast activity and reducing bone resorption, leading to net gains in bone mass. The drug is indicated primarily for postmenopausal women at risk of fracture.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); brand team likely focused on lifecycle extension and managed decline.
Mechanism of Action
hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis
Started Apr 2011
41 enrolled
Post Menopausal Osteoporosis
A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Started Apr 2010
6,054 enrolled
Postmenopausal Osteoporosis
Bioequivalence Study of Ibandronate Sodium Tablets 150 mg Under Fasting Condition
Started Sep 2008
100 enrolled
Healthy
A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis.
Started May 2006
356 enrolled
Post Menopausal Osteoporosis
A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate)
Started Feb 2006
67 enrolled
Post Menopausal Osteoporosis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.