NDAORALTABLETPriority Review
Approved
Sep 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Priority Review
HEPSERA (adefovir dipivoxil) by Gilead Sciences is [see microbiology ()]. First approved in 2002.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HEPSERA (adefovir dipivoxil) is an oral nucleotide reverse transcriptase inhibitor approved for chronic hepatitis B virus (HBV) infection. It works by inhibiting HBV polymerase, reducing viral replication and slowing disease progression. This small-molecule antiviral is administered as an oral tablet.
LOE Approaching
Product is nearing loss of exclusivity with moderate competitive pressure (30/100), signaling reduced headcount investment and focus on transition strategy rather than growth initiatives.
Mechanism of Action
[See Microbiology ()].
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients
Started Jan 2015
400 enrolled
Hepatitis B, ChronicFibrosis
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
Started Sep 2011
300 enrolled
Chronic Hepatitis B
Lamivudine and Adefovir Dipivoxil Fixed Dose Combination
Started Feb 2011
40 enrolled
Hepatitis B, Chronic
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
Started Aug 2008
10 enrolled
Hepatitis B, Chronic
Adding Adefovir Dipivoxil Versus Switching to Entecavir in Patients With Lamivudine-resistant Chronic Hepatitis B
Started Apr 2007
219 enrolled
Chronic Hepatitis B
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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.