NDAORALTABLET, DELAYED RELEASE
Approved
Oct 2010
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
2
Data completeness
6/8 — Strong
ATELVIA (risedronate sodium) by Teva is agent. First approved in 2010.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ATELVIA is a delayed-release oral formulation of risedronate sodium, a bisphosphonate agent approved in 2010 for osteoporosis management. It works by inhibiting osteoclast-mediated bone resorption, reducing bone turnover and remodeling activation frequency. The delayed-release formulation allows administration with food, improving tolerability and adherence compared to immediate-release alternatives.
$0.224MPart D
LOE ApproachingDeclining
1.6 years to LOEAs LOE approaches in 1.6 years, this product faces significant generic erosion; the team is likely focused on cost optimization and managing decline rather than growth initiatives.
Mechanism of Action
agent. At the cellular level, risedronate 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 risedronate treatment reduces bone…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
SOLID-Effect of Risedronate Sodium at Distal Radius in Colle's Fracture.
Started Mar 2007
141 enrolled
Colles' Fracture
Risedronate Sodium in Post Menopausal Osteoporosis
Started Jan 2004
246 enrolled
Osteoporosis, Postmenopausal
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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.