Company names starting with "U"

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.


Ultragenyx Pharamceutical Inc.
Mepsevii (Injection) (Intravenous) vestronidase alfa-vjbk
Drug Classes: recombinant human lysosomal beta glucuronidase
NDA Applicant: Ultragenyx Pharamceutical Inc.      BLA No.: 761047  Prod. No.: 001 Rx (10MG/5ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 15, 2024Orphan Designation: Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome)
Approved Labeled Indication: Indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (PMS VII, Sly syndrome).
Exclusivity Protected Indication: Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome).

United Therapeutics Corporation
Unituxin (Injection) (Intravenous) dinutuximab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == GD2-binding monoclonal antibody
NDA Applicant: United Therapeutics Corporation      BLA No.: 125516  Prod. No.: 001 Rx (17.5MG/5ML (3.5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 10, 2022Orphan Designation: Treatment of neuroblastoma
Approved Labeled Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy
Exclusivity Protected Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy



Last edited: 15 November 2022
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