Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan 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 Exclusivity | Jun 7, 2028 | Orphan 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
NDA Applicant: United Therapeutics Corporation BLA No.: 125516 Prod. No.: 001 Rx (17.5MG/5ML (3.5MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 10, 2022 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jun 11, 2027 | Orphan 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. |