Horizon Pharma plc HZNP announced that the U.S. Patent and Trademark Office (USPTO) has issued an additional notice of allowance for U.S. patent application number 14/563,000 with claims covering Rayos (prednisone) delayed-release tablets.
The notice of allowance concludes the substantive examination of the patent application and will result in the issuance of a U.S. patent after the administrative processes are complete. The patent scheduled to issue from this application will expire on Aug 3, 2027. Once the patent is issued, Horizon Pharma plans to list it in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. This will be the eighth U.S. patent to be listed in the Orange Book for Rayos.
We remind investors that Rayos, a proprietary delayed-release formulation of low-dose prednisone, is approved for the treatment of rheumatoid arthritis (RA), polymyalgia rheumatic, systemic lupus erythematosus and several other indications. Outside the U.S., Rayos is marketed under the trade name Lodotra, for the treatment of moderate-to-severe active RA when accompanied by morning stiffness. Horizon Pharma has granted commercialization rights to Lodotra in Europe, Asia (excluding Japan) and Latin America to Mundipharma.
We note that Rayos sales have been benefiting from prescription volume growth. The company expects expanded commercial efforts in the Rheumatology unit to continue enhancing prescription growth of its medicines in the second half of the year.
Horizon Pharma is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the health care sector include Corcept Therapeutics Inc. CORT, ANI Pharmaceuticals, Inc. ANIP and Geron Corp. GERN. All the three stocks sport a Zacks Rank #1 (Strong Buy).
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