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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: pegvaliase-pqpz
Trade Name: PALYNZIQ
Date Designated: 03/08/1995
Orphan Designation: Treatment of hyperphenylalaninemia
Orphan Designation Status: Designated/Approved
BioMarin Pharmaceutical Inc.
105 Digital Drive
Novato, California 94949
United States

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

Marketing approved:

1 Generic Name: pegvaliase-pqpz
Trade Name: PALYNZIQ
Marketing Approval Date: 05/24/2018
Approved Labeled Indication: Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
Exclusivity End Date: 05/24/2025 
Exclusivity Protected Indication* :  Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
2 Generic Name: pegvaliase-pqpz
Trade Name: Palynziq
Marketing Approval Date: 02/27/2026
Approved Labeled Indication: to reduce blood phenylalanine concentrations in adult and pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
Exclusivity End Date: 02/27/2033 
Exclusivity Protected Indication* :  to reduce blood phenylalanine concentrations in pediatric patients 12 years of age and older with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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