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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: osimertinib
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
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.

Marketing approved:

1 Generic Name: osimertinib
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
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
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
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
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  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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