Highland Therapeutics Inc. (Highland), a pharmaceutical company, announced that the US Patent and Trademark Office (USPTO) has issued three patents and one Notice of Allowance (NOA) for the Company’s lead products. Two patents are for HLD-200, a next-generation formulation of methylphenidate; the other patent and the NOA are for HLD-100, a next-generation formulation of amphetamine. Both products are designed to be taken once-daily in the evening with the objective of controlling symptoms of ADHD immediately upon awakening and throughout the day. All patents are owned by Highland’s subsidiary, Ironshore Pharmaceuticals & Development, Inc. (Ironshore)
“With these latest issuances from the USPTO, we will have six patents protecting our late-stage compounds. We intend to further enhance our intellectual property portfolio with additional patent applications throughout 2015 and beyond,” said David Lickrish, Ironshore’s CEO. “Our company understands that the current gap in coverage of ADHD symptoms during the morning routine is a major problem for many families that struggle during this critical time of day. Ironshore remains unwavering in its commitment to the development of a portfolio of products that may help to improve the lives of ADHD patients and their families. Ironshore will continue to be a reliable partner for physicians as we advance our new treatment paradigms through clinical development. The first of two planned pivotal studies for HLD-200 is expected to start in the second quarter of 2015, with top-line results anticipated within nine months.”
Patent numbers 9,034,902 “Methods of Treatment for Attention Deficit Hyperactivity Disorder”, 9,023,389 “Compositions for Treatment of Attention Deficit Hyperactivity Disorder” and 9,028,868 “Methods and Compositions for Treatment of Attention Deficit Disorder” will expire in 2032. The NOA is for patent application No14/255,529. When issued, the patent arising from this NOA will also expire 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 and HLD-100.