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.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 31, 2012 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
gemtuzumab ozogamicin (For Injection) (Intravenous) Mylotarg
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 761060 Prod. No.: 001 Rx (4.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 17, 2007 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 1, 2024 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older Exclusivity Protected Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 16, 2027 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Mylotarg is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older. Exclusivity Protected Indication: For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older |
glucarpidase (For Injection) (Intravenous) Voraxaze
NDA Applicant: BTG International Inc. BLA No.: 125327 Prod. No.: 001 Rx (1,000UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 17, 2019 | Orphan Designation: Treatment of patients at risk of methotrexate toxicity Approved Labeled Indication: Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function. |
golimumab (Injection) (Intravenous) Simponi Aria
NDA Applicant: Janssen Biotech, Inc. BLA No.: 125433 Prod. No.: 001 Rx (50MG/4ML (12.5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 29, 2027 | Orphan Designation: Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age. Approved Labeled Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older Exclusivity Protected Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age |