NDAORALTABLETPriority Review
Approved
Sep 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
Priority Review
FOSAMAX (alendronate sodium) by Merck & Co. is action. First approved in 1995.
Drug data last refreshed 8h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FOSAMAX (alendronate sodium) is a bisphosphonate small molecule that treats osteoporosis and related bone loss conditions by inhibiting osteoclast-mediated bone resorption. It works by localizing to sites of active bone resorption and preventing osteoclasts from creating the ruffled border needed for bone breakdown, allowing bone formation to exceed resorption over time. The drug is administered orally as a tablet and requires continuous dosing to maintain suppression of bone turnover.
$0.449BPart D
LOE ApproachingDeclining
As a mature product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely transitioning to defensive positioning and cost optimization rather than growth initiatives.
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 (8)
A Study of Alendronate Sodium Vitamin D3 Tablets on Knee Osteoarthritis
Started Jul 2021
60 enrolled
Knee Osteoarthritis
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
Started Dec 2006
80 enrolled
Healthy
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
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
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Started Oct 2003
22 enrolled
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.