Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 17, 2020 | Orphan Designation: Prevention of Japanese encephalitis virus in pediatric patients. Approved Labeled Indication: IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older. Exclusivity Protected Indication: To extend the age range to include infants, children, and adolescents 2 months to less than 17 years of age for active immunization for the prevention of disease caused by Japanese encephalitis virus. |