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. |
ViroPharma Biologics LLC
Cinryze (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: ViroPharma Biologics LLC BLA No.: 125267 Prod. No.: 001 Rx (500U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 10, 2015 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2025 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). Exclusivity Protected Indication: CINRYZE (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in pediatric patients ages 6-11 with Hereditary Angioedema (HAE). |