Search Orphan Drug Designations and Approvals
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Generic Name: | osimertinib | ||||||||||||||||
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Trade Name: | Tagrisso | ||||||||||||||||
Date Designated: | 09/04/2014 | ||||||||||||||||
Orphan Designation: | Treatment of epidermal growth factor receptor mutation-positive non-small cell lung cancer | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
AstraZeneca Pharmaceuticals LP P. O. Box 8355 1800 Concord Pike Wilmington, Delaware 19803 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: | osimertinib |
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Trade Name: | Tagrisso | |
Marketing Approval Date: | 11/13/2015 | |
Approved Labeled Indication: | For treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy | |
Exclusivity End Date: | 11/13/2022 | |
Exclusivity Protected Indication* : | For treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR TKI therapy | |
2 | Generic Name: | osimertinib |
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Trade Name: | Tagrisso | |
Marketing Approval Date: | 04/18/2018 | |
Approved Labeled Indication: | TAGRISSO® is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
Exclusivity End Date: | 04/18/2025 | |
Exclusivity Protected Indication* : | TAGRISSO® is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
3 | Generic Name: | osimertinib |
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Trade Name: | Tagrisso | |
Marketing Approval Date: | 12/18/2020 | |
Approved Labeled Indication: | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
Exclusivity End Date: | 12/18/2027 | |
Exclusivity Protected Indication* : | adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
4 | Generic Name: | osimertinib |
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Trade Name: | Tagrisso | |
Marketing Approval Date: | 02/16/2024 | |
Approved Labeled Indication: | in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
Exclusivity End Date: | TBD | |
5 | Generic Name: | osimertinib |
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Trade Name: | Tagrisso | |
Marketing Approval Date: | 09/25/2024 | |
Approved Labeled Indication: | treatment of adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test | |
Exclusivity End Date: | TBD | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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