Search Orphan Drug Designations and Approvals
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| Generic Name: | daratumumab | ||||||||||||||||
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| Trade Name: | Darzalex | ||||||||||||||||
| Date Designated: | 05/06/2013 | ||||||||||||||||
| Orphan Designation: | Treatment of multiple myeloma | ||||||||||||||||
| Orphan Designation Status: | Designated/Approved | ||||||||||||||||
| Sponsor: |
Janssen Biotech, Inc. 920 Route 202 South PO Box 300 Raritan, New Jersey 08869 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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| 1 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 11/16/2015 | |
| 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 End Date: | 11/16/2022 | |
| 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 | |
| 2 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 11/21/2016 | |
| 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 End Date: | 11/21/2023 | |
| 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. | |
| 3 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 06/16/2017 | |
| 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 End Date: | 06/16/2024 | |
| 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. | |
| 4 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 05/07/2018 | |
| 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 End Date: | 05/07/2025 | |
| 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 | |
| 5 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 06/27/2019 | |
| Approved Labeled Indication: | DARZALEX is indicated for the 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 and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. | |
| Exclusivity End Date: | N/A | |
| 6 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 09/26/2019 | |
| 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 End Date: | 09/26/2026 | |
| 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 | |
| 7 | Generic Name: | daratumumab |
|---|---|---|
| Trade Name: | Darzalex | |
| Marketing Approval Date: | 08/20/2020 | |
| Approved Labeled Indication: | Treatment of adult patients with multiple myeloma in combination with carfilzomib and dexamethasone in patients who have received one to three prior lines of therapy | |
| Exclusivity End Date: | N/A | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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