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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: olaparib
Trade Name: Lynparza
Date Designated: 05/15/2018
Orphan Designation: Treatment of primary peritoneal cancer
Orphan Designation Status: Designated/Approved
AstraZeneca Pharmaceuticals LP
1800 Concord Pike
P. O. Box 8355
Wilmington, Delaware 19803
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: olaparib
Trade Name: Lynparza
Marketing Approval Date: 08/17/2017
Approved Labeled Indication: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy; and treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.
Exclusivity End Date: 08/17/2024 
Exclusivity Protected Indication* :  Maintenance treatment of adult patients with recurrent primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.
2 Generic Name: olaparib
Trade Name: Lynparza
Marketing Approval Date: 12/19/2018
Approved Labeled Indication: Lynparza® is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum based chemotherapy. Select patients with gBRCAm advanced epithelial ovarian, fallopian tube or primary peritoneal cancer for therapy based on FDA-approved companion diagnostic for Lynparza.
Exclusivity End Date: 12/19/2025 
Exclusivity Protected Indication* :  Lynparza® is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced primary peritoneal cancer who are in complete or partial response to first-line platinum based chemotherapy.
3 Generic Name: olaparib
Trade Name: Lynparza
Marketing Approval Date: 05/08/2020
Approved Labeled Indication: Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either: a deleterious or suspected deleterious BRCA mutation, and/or genomic instability. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza.
Exclusivity End Date: 05/08/2027 
Exclusivity Protected Indication* :  LYNPARZA® is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinumbased chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by genomic instability.
*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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