NDAORALSOLUTIONPriority Review
Approved
Dec 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 1h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZIAGEN (abacavir sulfate) is a nucleoside reverse transcriptase inhibitor (NRTI) approved in 1998 for HIV-1 treatment. It is an oral solution formulation used as part of combination antiretroviral therapy. The drug works by inhibiting HIV reverse transcriptase, preventing viral replication in infected patients.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential team right-sizing and transition planning opportunities.
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.
Clinical Trials (3)
Bioequivalence and Pharmacokinetic Study of Prurisol™ and Abacavir Sulfate in Healthy Volunteers
Started Mar 2014
18 enrolled
Psoriasis
ZIAGEN® Post-marketing Surveillance
Started Nov 2010
671 enrolled
Infection, Human Immunodeficiency Virus I
Cyclosporine A in Combination With Abacavir Sulfate, Lamivudine, and Zidovudine and Lopinavir/Ritonavir in HIV
Started Feb 2004
54 enrolled
HIV Infections
Career Relevance
ZIAGEN roles focus on established market management, patient access, and regulatory compliance rather than innovation or expansion. Career growth on this product is limited by its LOE-approaching status and static clinical profile.
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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.