NDAORALTABLET
Approved
Apr 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
5/8 — Partial
FOSAMAX PLUS D (alendronate sodium and cholecalciferol) by Merck & Co.. Approved for vitamin d [epc]. First approved in 2005.
Drug data last refreshed 32m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Fosamax Plus D is a fixed-dose oral tablet combining alendronate sodium (a bisphosphonate) with cholecalciferol (vitamin D3) for the treatment of osteoporosis in postmenopausal women. The alendronate inhibits bone resorption by suppressing osteoclast activity, while vitamin D enhances calcium absorption and bone health. This combination addresses both bone density and nutritional deficiency in a single formulation.
$0.604MPart D
LOE ApproachingMature product approaching loss of exclusivity with modest Part D utilization; brand teams should prepare for transition planning and defend market share against generic competition.
Mechanism of Action
Pharmacologic Class:
Vitamin D
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
The Study of the Early Administration of Alendronate on Prevention of Bone Loss After Hip Fracture.
Started Jan 2003
10 enrolled
Osteoporosis
Career Relevance
Fosamax Plus D offers limited growth opportunities due to its LOE Approaching status and modest claim volume (1,890 Part D claims in 2023). Professionals joining this product team should focus on defensive strategies, operational efficiency, and preparation for generic transition or portfolio repositioning.
Brand Manager
Worked on FOSAMAX PLUS D at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
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.