NDAORALTABLET, EFFERVESCENT
Approved
Mar 2012
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
9
Data completeness
6/8 — Strong
BINOSTO (alendronate sodium) by Radius Health is action. First approved in 2012.
Drug data last refreshed 18h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BINOSTO is an effervescent tablet formulation of alendronate sodium, a bisphosphonate that inhibits osteoclast-mediated bone resorption. It is used to treat osteoporosis by localizing preferentially to sites of bone resorption and suppressing osteoclast activity without interfering with bone formation. The drug works by being incorporated into the bone matrix where it continuously suppresses new resorption surfaces, allowing bone formation to exceed resorption and progressively increase bone mass.
$0.539MPart D
LOE Approaching5.1 years to LOEProduct is at peak lifecycle stage with 5.2 years until LOE; brand team focus is on market defense and maximizing remaining patent exclusivity before generic entry.
Mechanism of Action
action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts. The osteoclasts adhere normally to the bone surface but lack the ruffled border that is indicative of active resorption. Alendronate does not interfere with…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (9)
A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis
Started Jul 2021
60 enrolled
Knee Osteoarthritis
The Use of Steovess/Binosto After Denosumab Discontinuation to Prevent Increase in Bone Turnover
Started Nov 2019
30 enrolled
Erosive Osteoarthritis
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
Started Dec 2006
80 enrolled
Healthy
A Randomized, Double-Blind Study to Compare the Efficacy of Treatment With Denosumab Versus Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density.
Started May 2006
1,189 enrolled
OsteoporosisOsteopenia
A Multicenter, Randomized Placebo Controlled Pilot MicroCT Study to Estimate the Effect of Treatment With Denosumab (AMG 162) and Alendronate Sodium in Postmenopausal Women With Low Bone Mineral Density
Started May 2006
247 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.