Generic names starting with "D"

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.


daclizumab (Injection) (Intravenous) Zenapax
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.

daratumumab (Injection) (Intravenous) Darzalex
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD38-directed cytolytic antibody
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761036  Prod. No.: 001 Rx (100MG/5ML); 002 Rx (400MG/20ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2022Orphan 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 ExclusivityNov 21, 2023Orphan 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 ExclusivityJun 16, 2024Orphan 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 ExclusivityMay 7, 2025Orphan 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 ExclusivitySep 26, 2026Orphan 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

daratumumab and hyaluronidase-fihj (Injection) (Subcutaneous) Darzalex Faspro
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD38-directed cytolytic antibody
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 761145  Prod. No.: 001 Rx (1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 15, 2028Orphan 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

Dengue Tetravalent Vaccine, Live (For Injection) (Subcutaneous) Dengvaxia
NDA Applicant: Sanofi Pasteur Inc.      BLA No.: 125682  Prod. No.: 001 Rx (4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityMay 1, 2031 

denileukin diftitox (Injection) (Intravenous) Ontak
Drug Classes: Antineoplastics:Antineoplastics, Other == CD25-directed cytotoxin
NDA Applicant: Eisai, Incorporated      BLA No.: 103767  Prod. No.: 001 Disc (150MCG/ML (300MCG/2ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2006Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma
Approved Labeled Indication: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.

denosumab (Injection) (Subcutaneous) Xgeva
Drug Classes: Metabolic Bone Disease Agents == RANK ligand (RANKL) inhibitor
NDA Applicant: Amgen, Inc.      BLA No.: 125320  Prod. No.: 003 Rx (120MG/1.7ML (70MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2020Orphan Designation: Treatment of patients with giant cell tumor of bone
Approved Labeled Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Exclusivity Protected Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Exclusivity Type: Orphan Drug ExclusivityDec 5, 2021Orphan Designation: Treatment of hypercalcemia in malignancy
Approved Labeled Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.
Exclusivity Protected Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy.

Digoxin Immune Fab (Ovine) (For Injection) (Intravenous) Digibind
Drug Classes: Cardiovascular Agents:Antiarrhythmics == Cardiovascular Agents:Cardiovascular Agents, Other == cardiac glycoside
NDA Applicant: Wellcome Foundation Limited Wellcome Research Laboratories      BLA No.: 103141  Prod. No.: 001 Disc (38MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 22, 1993Orphan Designation: Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy.

dinutuximab (Injection) (Intravenous) Unituxin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == GD2-binding monoclonal antibody
NDA Applicant: United Therapeutics Corporation      BLA No.: 125516  Prod. No.: 001 Rx (17.5MG/5ML (3.5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 10, 2022Orphan Designation: Treatment of neuroblastoma
Approved Labeled Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy
Exclusivity Protected Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy

dornase alfa (Solution) (Inhalation) Pulmozyme
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == recombinant human deoxyribonuclease 1 (rhDNase) enzyme
NDA Applicant: Genentech, Inc.      BLA No.: 103532  Prod. No.: 001 Rx (2.5MG/2.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 30, 2000Orphan Designation: To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis.
Approved Labeled Indication: In conjunction with standard therapies in the management of cystic fibrosis patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function.

durvalumab (Injection) (Intravenous) Imfinzi
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == programmed death ligand-1 (PD-L1) blocking antibody
NDA Applicant: AstraZeneca UK Ltd      BLA No.: 761069  Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 27, 2027Orphan Designation: Treatment of small cell lung cancer
Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Exclusivity Protected Indication: Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).



Last edited: 15 November 2022
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