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. Approved for osteoporosis, postmenopausal, osteoporosis. First approved in 1998.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTONEL (risedronate sodium) is a bisphosphonate oral agent approved in 1998 that inhibits osteoclast-mediated bone resorption by reducing bone turnover at remodeling sites. It is indicated for postmenopausal osteoporosis, osteoporosis treatment, Colles' fracture, and adjunctive use in breast and prostate cancer. The drug works by adhering osteoclasts to bone surface while blocking their active resorptive capacity, thereby slowing bone loss.
$1MPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Medicare spending ($1M, 1,617 claims in 2023), indicating shrinking market presence and team downsizing or consolidation.
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 (2)
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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.