Transcept Pharmaceuticals Announces Listing of New U.S. Patent for Intermezzo in FDA's Orange Book
PR NewswirePress Release: Transcept Pharmaceuticals, Inc. – Tue, Aug 21, 2012 4:40 PM EDT
POINT RICHMOND, Calif., Aug. 21, 2012 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (TSPT) today announced that the U.S. Food and Drug Administration has listed U.S. Patent No. 8,242,131 (the '131 patent) in its Approved Drug Products with Therapeutic Equivalence Evaluations, or "Orange Book." This patent, which was issued by the United States Patent and Trademark Office (USPTO) on August 14, 2012, includes claims directed to methods of treating middle-of-the-night insomnia with low doses of zolpidem. The '131 patent will expire no sooner than 2029.
As part of the collaboration agreement between Purdue Pharmaceutical Products L.P. (Purdue) and Transcept, Transcept is eligible to receive a $10 million milestone payment from Purdue in connection with the '131 patent being listed in the Orange Book. Pursuant to this agreement, Transcept is also eligible to receive up to an additional $70 million in milestone payments related to the achievement of certain U.S. net sales targets of Intermezzo, as well as a royalty on U.S. net sales of Intermezzo that ranges from the mid-teens to the mid-20% level.
This patent adds to the Intermezzo intellectual property portfolio, which includes two previously issued U.S. patents that are currently listed in the Orange Book. In addition, the USPTO issued a Notice of Allowance on July 18, 2012, for an Intermezzo patent application directed to compositions for treating middle-of-the-night insomnia. Intermezzo was also granted three years of Hatch-Waxman regulatory exclusivity by the FDA.
