KemPharm, Inc. Announces Orange Book Listing for Six
SDX is KemPharm’s proprietary prodrug of d-methylphenidate (d-MPH) and the principal active pharmaceutical ingredient (API) of AZSTARYS ™
CELEBRATION, Fla., May 26, 2021 (GLOBE NEWSWIRE) – KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, today announced that six U.S. patents governing serdexmethylphenidate ( SDX), KemPharm’s prodrug d-methylphenidate (d-MPH), and AZSTARYS ™, are now listed in the US Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations “, Commonly known as” Orange Book “. In addition, the Orange Book listing confirms the status of SDX, which is AZSTARYS ‘main API, as a New Chemical Entity (NCE), which offers at least five years of commercial exclusivity.
AZSTARYS was conditionally approved by the FDA in March 2021 as a once-daily product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age and older. Recently, SDX was classified as a Schedule IV controlled substance by the United States Drug Enforcement Administration (DEA) and therefore has been officially approved for marketing in the United States. experimental treatment of stimulant use disorder (SUD).
“The Orange Book listing of these six patents covering the composition of matter of SDX and its method of use is an important step in protecting additional SDX products from AZSTARYS and KemPharm against patent infringement,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “In addition, this is another important value creation event for SDX as we move towards the planned commercialization of AZSTARYS and the planned launch of the clinical program for KP879.”
Of the listed patents, U.S. Patent No. 9,079,928, which is scheduled to expire July 27, 2032, is a Composition of Matter patent. The other five patents are all scheduled to expire on December 9, 2037 and include U.S. Patent No. 10,584,112 and U.S. Patent No. 10,584,113 (Composition of Matter and Method of Use Patents), U.S. Patent No. 10,759,778. (method of use) Patent No. 10,858,341 (composition of matter and method of use) and US Patent No. 10,954,213 (composition of matter). All or some of these patents may be subject to patent term extensions.
The Orange Book listing confirms that SDX, which is contained in AZSTARYS, is an NCE, which offers five years of market exclusivity which expires on May 7, 2026. During the NCE exclusivity period, the FDA cannot approve a new application Drug Application (NDA), an Abbreviated New Drug Application (ANDA), or a 505 (b) (2) application for another product based on the same API, regardless of the indication. If another party attempts to rely on SDX clinical data for a generic or other new drug application, which cannot be filed for four years after approval, the patentee can sue and receive a stay. 30-month automatic, which has the practical implication of extending the exclusivity period to an additional two and a half years. These periods of market exclusivity run parallel to the applicable patent exclusivity period, but may offer the advantage of avoiding patent defense costs during the first four years of NCE exclusivity and during the first years of patent protection. sales and marketing.
The patents listed in the Orange Book cover drugs that the FDA has approved and found to be both safe and effective for use by the general public. Inclusion in the book’s patent list may make it easier for drug makers to monitor new generic drugs that could potentially hit the US market and infringe their own patents.
About AZSTARYS ™:
AZSTARYS ™ is an FDA approved once-daily product for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients six years of age or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
The full approved prescribing information for AZSTARYS can be downloaded as a PDF here: https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Final_20210302.pdf
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT® Technology (Ligand Activated Therapy). KemPharm uses its exclusive LAT® technology to generate improved prodrug versions of FDA approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug pipeline focuses on the high need areas of Attention Deficit Hyperactivity Disorder, or ADHD, Stimulant Use Disorders (SUD), and Rare CNS Diseases, including including idiopathic hypersomnia (HI). KemPharm’s lead clinical development candidate for the treatment of SUD, KP879, is based on its d-methylphenidate prodrug, known as serdexmethylphenidate (SDX). Additionally, KemPharm has received FDA approval for AZSTARYS ™, a new once-daily treatment for ADHD in patents six years and older, and for APADAZ®, an immediate release combination product containing benzhydrocodone, a prodrug of hydrocodone and acetaminophen. For more information on KemPharm and its portfolio of prodrug product candidates, visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.
Caution regarding forward-looking statements:
This press release may contain forward-looking statements based on the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts and can be identified by the use of words such as “may”, “will”, “expect”, “plan”, ” estimate “,” anticipate “”, “plan”, “believe”, “potential”, “should”, “continue” or negative versions of these or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the potential benefits of NCE exclusivity, and the potential benefits of patent exclusivity for SDX, are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks. this could have a significant impact on current plans. The risks relating to KemPharm’s business are described in detail in KemPharm’s quarterly report on Form 10-Q for the quarter ended March 31, 2021 and in other documents filed by KemPharm with the Securities and Exchange Commission. KemPharm has no obligation to, and expressly disclaims any obligation to update or change any forward-looking statements, whether as a result of new information, future events or otherwise.