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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: niraparib
Trade Name: Zejula
Date Designated: 04/30/2010
Orphan Designation: Treatment of ovarian cancer
Orphan Designation Status: Designated/Approved
GlaxoSmithKline, LLC.
1000 Winter St.
Suite 3300
Waltham, Massachusetts 02451
United States

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

Marketing approved:

1 Generic Name: niraparib
Trade Name: Zejula
Marketing Approval Date: 03/27/2017
Approved Labeled Indication: Indicated for 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
Exclusivity End Date: 03/27/2024 
Exclusivity Protected Indication* :  Indicated for maintenance treatment of adult patients with recurrent epithelial ovarian cancer who are in a complete or partial response to platinum-based chemotherapy
2 Generic Name: niraparib
Trade Name: Zejula
Marketing Approval Date: 10/23/2019
Approved Labeled Indication: ZEJULA? is indicated for the treatment of adult patients with advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either, (1) a deleterious or suspected deleterious BRCA mutation, or (2) genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy (Indication withdrawn)
Exclusivity End Date: 09/14/2022 
Exclusivity Protected Indication* :  Indicated for the treatment of adult patients with advanced ovarian cancer who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a deleterious or suspected deleterious BRCA mutation, or genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy (Indication withdrawn)
3 Generic Name: niraparib
Trade Name: Zejula
Marketing Approval Date: 04/29/2020
Approved Labeled Indication: ZEJULA is indicated for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy
Exclusivity End Date: 04/29/2027 
Exclusivity Protected Indication* :  Indicated for the maintenance treatment of adult patients with advanced epithelial ovarian cancer who are in a complete or partial response to first-line platinum-based chemotherapy.
*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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