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Heplisav-B Injectable Product, 3-dose regimen
Heplisav-B is a marketed injectable product administered in a 3-dose regimen, currently positioned in the hepatitis B vaccination market. The drug's key composition patent is set to expire in 2028, providing a period of exclusivity that supports its market position. The primary risk is the lack of clear revenue data and key trial results, which may affect investor confidence and market adoption.
At a glance
| Generic name | Heplisav-B Injectable Product, 3-dose regimen |
|---|---|
| Also known as | 3-dose regimen |
| Sponsor | Mercy Medical Center |
| Modality | Biologic |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- Comparison Between 2-dose Versus 3-dose Regimens of Heplisav B in Cirrhosis (PHASE4)
- A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses (PHASE2, PHASE3)
- A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
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