The Notice of Allowance is for U.S. Patent Application No. 14/230,053, "Compositions for Treatment of Attention Deficit Hyperactivity Disorder" owned by Highland’s wholly owned subsidiary, Ironshore Pharmaceuticals & Development, Inc. ("Ironshore") and is the second Notice of Allowance received this month that relates to HLD-200.
"The pending issuance of these two important patents validates the tremendous effort of our team over the past several years, and underscores the novelty of our drug delivery platform," said David Lickrish, Highland’s President and Chief Executive Officer.
"The positive top-line data from our recently completed Phase III trial highlight the potential benefits of nighttime dosing in order to obtain meaningful control over symptoms of ADHD in the morning and throughout the day.
"Although our technology was specifically developed to address the significant challenges faced by families that struggle with ADHD during the morning routine, we believe there are several important applications beyond methylphenidate and amphetamine, and expect to broaden our development pipeline in 2015."
The Notice of Allowance signals the end of the substantive examination of the patent application by the USPTO. After the administrative processing period is complete, a U.S. patent will be issued, likely early in January 2015.
The U.S. patent scheduled to issue from this application will expire in 2032. After issuance, Ironshore plans to list the patent in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, upon US regulatory approval of HLD-200.