KMPH - KemPharm reports orange book listing for six U.S. patents covering serdexmethylphenidate

KemPharm (KMPH) announces that six U.S. patents governing serdexmethylphenidate ((SDX)), the company's prodrug of d-methylphenidate (d-MPH), and Azstarys, are now listed in the “Orange Book.” Among the listed patents, U.S. Patent No. 9,079,928, due to expire on July 27, 2032, is a composition of matter patent.The other five U.S. patents are all slated to expire on December 9, 2037 and include Patent No. 10,584,112 and Patent No. 10,584,113 (composition of matter and method of use patents), Patent No. 10,759,778 (method of use), Patent No. 10,858,341 (composition of matter and method of use) and Patent No. 10,954,213 (composition of matter). All or some of these patents may be subject to patent term extension. The Orange Book listing confirms that SDX, which is contained within Azstarys, is a new chemical entity, which provides five years of market exclusivity that expires on May 7, 2026.During the NCE exclusivity period, the FDA cannot approve a NDA, an

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KemPharm reports orange book listing for six U.S. patents covering serdexmethylphenidate