Horizon Pharma Receives Two Additional Patents on Ravicti

May 8, 2018

Horizon Pharma plc (Nasdaq:HZNP) announced on 5/8/18 that it has received two Notices of Allowance from the United States Patent and Trademark Office for U.S. patent application numbers 15/457,643 and 15/687,132, both entitled "Methods of Therapeutic Monitoring of Nitrogen Scavenging Drugs” that cover Horizon's U.S. approved medicine RAVICTI (glycerol phenylbutyrate) Oral Liquid.

These Notices of Allowance conclude the substantive examination of the patent applications and will result in the issuance of two U.S. patents after administrative processes are completed.  The U.S. patents scheduled to issue from these applications will expire on September 22, 2030.  After issuance, Horizon plans to list the U.S. patents in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.

Ravicti is a nitrogen-binding agent indicated for chronic management of patients 2 months of age and older with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The incidence for the United States is predicted to be 1 urea cycle disorder patient for every 35,000 births presenting about 113 new patients per year across all age groups.

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