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 | Apr 22, 1993 | Orphan Designation: Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy. |
Wyeth Pharmaceuticals Inc.
Neumega (For Injection) (Subcutaneous) oprelvekin
Drug Classes: megakaryocyte growth factor
NDA Applicant: Wyeth Pharmaceuticals Inc. BLA No.: 103694 Prod. No.: 001 Disc (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 25, 2004 | Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia. |
Wyeth Pharmaceuticals LLC
Besponsa (For Injection) (Intravenous) inotuzumab ozogamicin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD22-directed antibody-drug conjugate (ADC)
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 761040 Prod. No.: 001 Rx (0.9MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2024 | Orphan Designation: Treatment of B-cell acute lymphoblastic leukemia Approved Labeled Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) Exclusivity Protected Indication: Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) |
Wyeth Pharmaceuticals LLC
Mylotarg (For Injection) (Intravenous) gemtuzumab ozogamicin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD33-directed antibody-drug conjugate
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 |
Wyeth Pharmaceuticals LLC
Prevnar 20 (Injection) (Intramuscular) 20-valent Pneumococcal Conjugate Vaccine
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 125731 Prod. No.: 001 Rx (0.5 ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jun 8, 2033 |
Wyeth Pharmaceuticals LLC
Trumenba (Injection) (Intramuscular) Meningococcal Group B Vaccine
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 125549 Prod. No.: 001 Rx (0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Oct 29, 2026 |