NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Jul 2020
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 34m ago · AI intelligence enriched 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RUKOBIA (fostemsavir tromethamine) is an oral extended-release small molecule HIV attachment inhibitor approved by the FDA in July 2020. It is indicated for treatment-experienced HIV-1 patients with evidence of viral suppression on a current antiretroviral regimen. The drug works by blocking HIV attachment to CD4 receptors, representing a novel mechanism in the HIV treatment armamentarium.
$0.091BPart D
LOE Approaching2.8 years to LOEModest Medicare uptake ($91M in 2023 claims) with approaching loss of exclusivity signals a contracting commercial footprint and likely restructuring of brand support teams.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
LOE in ~3 years — strategic planning for patent cliff underway
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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.