Patent No. 8,916,588 "Methods of Treatment for Attention Deficit Hyperactivity Disorder" and Patent No. 8,927,010 "Compositions for Treatment of Attention Deficit Hyperactivity Disorder" are owned by Highland’s wholly owned subsidiary, Ironshore Pharmaceuticals & Development (Ironshore) and will expire in 2032.
Ironshore intends to list the patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, upon U.S. regulatory approval of HLD-200.
"The issuance of these patents is a testament to the success of our intellectual property strategy and underscores the novelty of our DELEXIS technology," said David Lickrish, Highland’s President and Chief Executive Officer.
"We have recently filed new patent applications, and expect to file additional applications in 2015, to further broaden the Company’s patent portfolio. Given the recently announced Phase III data, we continue to believe that HLD-200 can fundamentally change treatment paradigms in ADHD and intend to position the drug as the emerging standard of care."