Company names starting with "V"

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.


Valneva Austria GmbH
Ixiaro (Injection) (Intramuscular) Japanese Encephalitis Vaccine, Inactivated, Adsorbed
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Valneva Austria GmbH      BLA No.: 125280  Prod. No.: 001 Rx (0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2020Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 10, 2015Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE)
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2025Orphan 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).



Last edited: 15 November 2022
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