Pharmaceutical Business review

KemPharm gets patent from USPTO for new prodrug of hydromorphone

The patent, which extends through 2032, provides composition of matter protection for KP511, KemPharm’s prodrug of hydromorphone, and adds to the intellectual property estate governing the company’s pain therapy portfolio.

KP201, KemPharm’s prodrug of hydrocodone, was previously granted composition of matter protection extending through 2031 (USPTO Patent No. 8,461,137).

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "The composition of matter patent for KP511 is a significant addition to KemPharm’s IP estate as we execute our strategy of advancing a franchise of new molecular entities that leverage our LAT prodrug technology to create what we believe will be improved versions of approved and widely-prescribed drugs. With patent protection for KP511 and KP201 extending to 2032 and 2031 respectively, we believe KemPharm is ideally positioned to answer the growing need within the pain therapeutic market, and society in general, for prescription opioid medications that deter abuse and reduce or eliminate opioid-induced constipation."

In preclinical studies, KP511 exhibited pharmacological characteristics that may suggest an improved safety profile compared to currently marketed hydromorphone products, possibly reducing or preventing symptoms of constipation and limiting abuse potential and risk of overdose.

KP511 also features tamper resistant properties that make it difficult to extract hydromorphone from the prodrug, which is not active until cleaved by normal metabolism in the GI tract.