Transcept (TSPT) Notified of ANDA Filing for Generic Intermezzo by Dr. Reddy's (RDY)

February 25, 2013 4:30 PM EST
On February 21, 2013, Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received a new Paragraph IV notice letter from Dr. Reddy's Laboratories, Inc. (NYSE: RDY) advising Transcept that it and Dr. Reddy's Laboratories, Ltd. (together, “Dr. Reddy's”) have filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (“FDA”) for generic versions of the 1.75mg and 3.5mg strengths of Intermezzo® (zolpidem tartrate) sublingual tablet C-IV. This Paragraph IV notice letter alleges that Transcept's U.S. Patent Nos. 7,658,945, 7,682,628, 8,242,131 and 8,252,809 are invalid, unenforceable and/or will not be infringed by Dr. Reddy's manufacture, use, importation, sale or offer for sale of the products for which its ANDA was submitted.

For additional information relating to Transcept's prior announcements regarding ANDA filings and related actions, see the Current Reports on Form 8-K filed on July 11, 2012, July 19, 2012, August 3, 2012, August 28, 2012, September 11, 2012, September 13, 2012, October 26, 2012 and December 26, 2012.

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