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 | Nov 25, 2027 | Orphan Designation: Treatment of neuroblastoma Approved Labeled Indication: in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy Exclusivity Protected Indication: treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy |
Darzalex (Injection) (Intravenous) daratumumab
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761036 Prod. No.: 001 Rx (100MG/5ML); 002 Rx (400MG/20ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2022 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent Exclusivity Protected Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 21, 2023 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 16, 2024 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, not including any overlap with the exclusivity awarded for the 2015 approval for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and immunomodulary agent or are double refractory to a proteasome inhibitor and immunomodulatory agent. |
| Exclusivity Type: Orphan Drug Exclusivity | May 7, 2025 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: In combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 26, 2026 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: Treatment of adult patients with multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy; in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor (PI); and as monotherapy, in patients who have received at least 3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immodulatory agent. Exclusivity Protected Indication: Indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant |
Darzalex Faspro (Injection) (Subcutaneous) daratumumab and hyaluronidase-fihj
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761145 Prod. No.: 001 Rx (1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 15, 2028 | Orphan Designation: treatment of light-chain (AL) amyloidosis Approved Labeled Indication: in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis Exclusivity Protected Indication: treatment of adult patients with newly diagnosed light chain (AL) amyloidosis |
Dengvaxia (For Injection) (Subcutaneous) Dengue Tetravalent Vaccine, Live
NDA Applicant: Sanofi Pasteur Inc. BLA No.: 125682 Prod. No.: 001 Rx (4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | May 1, 2031 |
Digibind (For Injection) (Intravenous) Digoxin Immune Fab (Ovine)
NDA Applicant: Wellcome Foundation Limited Wellcome Research Laboratories BLA No.: 103141 Prod. No.: 001 Disc (38MG)
| 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. |
Dupixent (Injection) (Subcutaneous) dupilumab
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 761055 Prod. No.: 001 Rx (300MG/2ML); 003 Rx (200MG/1.14ML); 004 Rx (300MG/2ML); 005 Rx (200MG/1.14ML); 006 Rx (100MG/0.67ML) BLA No.: 761055 Prod. No.: 002 Disc (300MG/2ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 20, 2029 | Orphan Designation: Treatment of eosinophilic esophagitis Approved Labeled Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) Exclusivity Protected Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) |
Dysport (For Injection) (Intramuscular) abobotulinumtoxinA
NDA Applicant: Ipsen Biopharm Limited BLA No.: 125274 Prod. No.: 001 Rx (300UNITS); 002 Rx (500UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 29, 2023 | Orphan Designation: Treatment of dynamic muscle contractures in pediatric cerebral palsy patients. Approved Labeled Indication: Treatment of lower limb spasticity in pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older |