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Horizon Pharma Announces the USPTO Issuance of an Additional Notice of Allowance

23-Apr-2015 | Source : AG-IP News | Visits : 5926
DUBLIN - Horizon Pharma plc. announced in a press release that the United States Patent and Trademark Office (USPTO) has granted a Notice of Allowance for US patent application number 14/329,631 (US publication number 2014-0328912), entitled "Delayed Release Tablet With Defined Core Geometry" that covers Horizon's US approved product RAYOS® (Prednisone) delayed release tablets.

"RAYOS is the first and only delayed-release prednisone approved by the FDA and the foundation of our specialty business unit," said Timothy P. Walbert, chairman, president and chief executive officer, Horizon Pharma plc. "It is important that we continue to protect this innovation and to provide access to patients who need treatment."
This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of a US patent after administrative processes are completed. The US patent scheduled to issue from this application will expire in 2024. After issuance, Horizon plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the sixth U.S. patent to be listed in the Orange Book for RAYOS.
 
RAYOS, known as LODOTRA® in Europe, is a proprietary delayed-release formulation of low-dose prednisone. The pharmacokinetic profile of RAYOS is different with an approximately four-hour lag time from that of immediate-release prednisone formulations. 
 
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