BONIVA
LOE ApproachingNDAINTRAVENOUSINJECTABLE
Approved
Jan 2006
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
3/8 — Basic
BONIVA by Roche is hydroxyapatite, which is part of the mineral matrix of bone. First approved in 2006.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BONIVA (ibandronate) is an intravenous bisphosphonate approved in 2006 for the treatment of osteoporosis in postmenopausal women. It works by inhibiting osteoclast activity to reduce bone resorption and turnover, leading to net gains in bone mass. The drug is administered via IV injection, offering an alternative to oral bisphosphonate therapy.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (30/100), signaling potential team rightsizing and transition to generic defense strategies.
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 (7)
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
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
PRIOR Study - A Study of Ibandronate (Boniva) in Postmenopausal Women With Osteoporosis or Osteopenia
Started Jan 2005
545 enrolled
Postmenopausal 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.