Harmony Biosciences reports receipt of Wakix paragraph IV certification notices

In a regulatory filing, Harmony Biosciences disclosed that on September 28 the company received paragraph IV certification notices from Novugen Pharma Sdn. Bhd. and Lupin Ltd. advising that the ANDA Filers had each filed with the U.S. Food and Drug Administration an Abbreviated New Drug Application, or “ANDA,” seeking approval to manufacture and sell a generic version of the company’s product Wakix in the United States prior to the expiration of U.S. Patents Nos. 8,486,947 and 8,207,197, or the “challenged patents,” which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the “Orange Book” and which expire September 26, 2029 and March 7, 2030 respectively. “The Notices do not challenge U.S. Patent No. 8,354,430 which expires February 6, 2026. The Notices allege that the Challenged Patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of the generic product in the ANDAs. The company is currently reviewing the Notices and intends to vigorously defend and enforce its intellectual property rights protecting WAKIX. As of the date of this filing, the company is not aware of any other ANDA filers,” the filing stated.