Tradenames starting with "Z"

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


Zenapax (Injection) (Intravenous) daclizumab
Drug Classes: interleukin-2 receptor blocking antibody
NDA Applicant: Hoffmann-La Roche Inc.      BLA No.: 103749  Prod. No.: 001 Disc (25MG/5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 10, 2004Orphan Designation: Prevention of acute renal allograft rejection.
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Zevalin (Injection) (Intravenous) ibritumomab tiuxetan
Drug Classes: CD20-directed radiotherapeutic antibody
NDA Applicant: Acrotech Biopharma LLC      BLA No.: 125019  Prod. No.: 001 Rx (3.2MG/2ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 19, 2009Orphan Designation: Treatment of B-cell non-Hodgkin's lymphoma.
Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma

Zolgensma (Injection) (Intravenous) onasemnogene abeparvovec-xioi
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: Novartis Gene Therapies, Inc.      BLA No.: 125694  Prod. No.: 001 Rx (1.1X10E14 VG/KG VG/KG=VECTOR GENOMES PER KILOGRAM)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2026Orphan Designation: Treatment of spinal muscular atrophy
Approved Labeled Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Protected Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Type: Ref. Product ExclusivityMay 24, 2031 

Zynlonta (For Injection) (Intravenous) loncastuximab tesirine-lpyl
NDA Applicant: ADC Therapeutics SA      BLA No.: 761196  Prod. No.: 001 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2028Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy

Zynteglo (For Injection) (Intravenous) betibeglogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 17, 2034 



Last edited: 15 November 2022
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