Tradenames starting with "D"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Danyelza (Injection) (Intravenous) naxitamab-gqgk
NDA Applicant: Y-mABs Therapeutics, Inc      BLA No.: 761171  Prod. No.: 001 Rx (40MG/10ML (4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2027Orphan 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
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

Darzalex Faspro (Injection) (Subcutaneous) daratumumab and hyaluronidase-fihj
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

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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityMay 1, 2031 

Digibind (For Injection) (Intravenous) Digoxin Immune Fab (Ovine)
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.

Dysport (For Injection) (Intramuscular) abobotulinumtoxinA
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: Ipsen Biopharm Limited      BLA No.: 125274  Prod. No.: 001 Rx (300UNITS); 002 Rx (500UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 29, 2023Orphan 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



Last edited: 15 November 2022
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