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Viekira Pak (Copackaged) (DASABUVIR)
Dasabuvir, marketed as Viekira Pak by AbbVie, is a direct-acting antiviral agent used in the treatment of chronic hepatitis C, currently holding a significant market position with a key composition patent expiring in 2028. Its mechanism of action, which involves binding to the NS5B protein to inhibit viral replication, provides a strong therapeutic profile against hepatitis C. However, the drug faces competition from several same-class treatments, including ribavirin, telaprevir, boceprevir, simeprevir, and daclatasvir, some of which have earlier patent expiries and are already off-patent, posing a potential threat to its market share.
At a glance
| Generic name | DASABUVIR |
|---|---|
| Sponsor | AbbVie |
| Drug class | Hepatitis C Virus Non-Nucleoside NS5B Palm Polymerase Inhibitor |
| Target | Protein cereblon |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2014 |
Approved indications
- Chronic hepatitis C
Common side effects
Key clinical trials
- Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment (PHASE4)
- MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV (PHASE4)
- A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PHASE3)
- Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P (PHASE3)
- A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (PHASE3)
- Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- Study of Oral Treatments for Hepatitis C (PHASE4)
- Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |