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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant von Willebrand factor (rhVWF)
Trade Name:
Date Designated: 11/23/2010
Orphan Designation: Treatment of von Willebrand disease
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: recombinant von Willebrand factor (rhVWF)
Trade Name:
Marketing Approval Date: 12/08/2015
Approved Labeled Indication: Indicated for on-demand treatment and control of bleeding episodes in adults (age 18 and older) diagnosed with von Willebrand disease (VWD)
Exclusivity End Date: 12/08/2022 
Exclusivity Protected Indication* :  Indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease (VWD)
2 Generic Name: recombinant von Willebrand factor (rhVWF)
Trade Name:
Marketing Approval Date: 04/13/2018
Approved Labeled Indication: Indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for perioperative management of bleeding
Exclusivity End Date: 04/13/2025 
Exclusivity Protected Indication* :  Indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for perioperative management of bleeding
3 Generic Name: recombinant von Willebrand factor (rhVWF)
Trade Name: Vonvendi
Marketing Approval Date: 01/28/2022
Approved Labeled Indication: For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy
Exclusivity End Date: 01/28/2029 
Exclusivity Protected Indication* :  For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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