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 |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 10, 2004 | Orphan 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
NDA Applicant: Acrotech Biopharma Inc. BLA No.: 125019 Prod. No.: 001 Rx (3.2MG/2ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 19, 2009 | Orphan 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
NDA Applicant: Novartis Gene Therapies, Inc. BLA No.: 125694 Prod. No.: 001 Rx (1.1X10E14 VG/KG VG/KG=VECTOR GENOMES PER KILOGRAM)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 24, 2026 | Orphan 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 Exclusivity | May 24, 2031 |
Zynlonta (For Injection) (Intravenous) loncastuximab tesirine-lpyl
NDA Applicant: ADC Therapeutics SA BLA No.: 761196 Prod. No.: 001 Rx (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 23, 2028 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2029 | Orphan Designation: Treatment of B-thalassemia major and intermedia Approved Labeled Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions Exclusivity Protected Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions |
| Exclusivity Type: Ref. Product Exclusivity | Aug 17, 2034 |
Zynyz (Injection) (Intravenous) retifanlimab-dlwr
NDA Applicant: Incyte Corporation BLA No.: 761334 Prod. No.: 001 Rx (500MG/20ML (25MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 22, 2030 | Orphan Designation: Treatment of Merkel cell carcinoma Approved Labeled Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) Exclusivity Protected Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) |