NDAORALTABLET
Approved
Mar 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
6/8 — Strong
ACTONEL (risedronate sodium) by Teva is agent. First approved in 1998.
Drug data last refreshed 12h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTONEL (risedronate sodium) is an oral bisphosphonate that inhibits osteoclast-mediated bone resorption, reducing bone turnover and preventing fractures in osteoporosis. It works by blocking osteoclast adhesion and resorptive activity at the cellular level. The drug is indicated for postmenopausal women and men with osteoporosis or those at risk of fracture.
$0.001BPart D
LOE ApproachingDeclining
As a mature product approaching loss of exclusivity, the brand team is likely consolidating; expect focus on generic transition planning and limited new hire activity.
Mechanism of Action
agent. At the cellular level, ACTONEL inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption (for example, lack of ruffled border). Histomorphometry in rats, dogs, and minipigs showed that ACTONEL treatment reduces bone turnover…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
Efficacy and Safety of Actonel® After Denosumab Discontinuation in Postmenopausal Osteoporosis Women
Started Jan 2023
149 enrolled
Postmenopausal Osteoporosis
Study to Evaluate the Safety and Efficacy of Denosumab and Actonel® in Post Menopausal Women Transitioned From Alendronate Therapy
Started Sep 2009
870 enrolled
Osteoporosis
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Started Mar 2007
141 enrolled
Colles' Fracture
ROSPA - Record on Satisfaction of Patients With Actonel 35 mg Once a Week
Started May 2005
7 enrolled
Osteoporosis
Efficacy and Safety of Risedronate (Actonel), a Third Generation Bisphosphonate in Patients With Ankylosing Spondylitis: a Phase 2 Pilot Study
Started Jun 2004
Ankylosing Spondylitis
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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.