Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: venetoclax
Trade Name: VENCLEXTA
Date Designated: 09/20/2012
Orphan Designation: Treatment of chronic lymphocytic leukemia
Orphan Designation Status: Designated/Approved
AbbVie, Inc
1 North Waukegan Road
Dept. PA72, Bldg. AP30
North Chicago, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: venetoclax
Trade Name: VENCLEXTA
Marketing Approval Date: 04/11/2016
Approved Labeled Indication: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy
Exclusivity End Date: 04/11/2023 
Exclusivity Protected Indication* :  Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy
2 Generic Name: venetoclax
Trade Name: VENCLEXTA
Marketing Approval Date: 06/08/2018
Approved Labeled Indication: VENCLEXTA® (venetoclax) indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy.
Exclusivity End Date: 06/08/2025 
Exclusivity Protected Indication* :  For treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), without 17p deletion, who have received at least one prior therapy.
3 Generic Name: venetoclax
Trade Name: VENCLEXTA
Marketing Approval Date: 05/15/2019
Approved Labeled Indication: VENCLEXTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Exclusivity End Date: 05/15/2026 
Exclusivity Protected Indication* :  Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-