Tradenames starting with "U"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Ultomiris (Injection) (Intravenous; Subcutaneous) ravulizumab-cwvz
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 761108  Prod. No.: 001 Rx (300MG/30ML (10MG/ML)); 002 Rx (300MG/3ML (100MG/ML)); 003 Rx (1,100MG/11ML (100MG/ML)); 004 Rx (245MG/3.5ML (70MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Approved Labeled Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Exclusivity Protected Indication: ULTOMIRIS_ is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
Exclusivity Type: Orphan Drug ExclusivityJun 7, 2028Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Approved Labeled Indication: Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)
Exclusivity Protected Indication: Treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)

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

Uplizna (Injection) (Intravenous) inebilizumab-cdon
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 761142  Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 11, 2027Orphan Designation: Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorders
Approved Labeled Indication: Uplizna is indicated for for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.
Exclusivity Protected Indication: Indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.



Last edited: 15 November 2022
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