POINT RICHMOND, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Transcept Pharmaceuticals, Inc. today announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for claims under U.S. patent application no. 11/060,641, which covers the composition and use of Intermezzo(R) (zolpidem tartrate sublingual tablet), the lead Transcept product candidate. Once issued, this patent will expire no earlier than February 2025.
"Other key elements in our program to protect Intermezzo(R) include a request to the U.S. Food and Drug Administration (FDA) to grant three years of Hatch-Waxman regulatory exclusivity to Intermezzo(R), and multiple applications on file with the USPTO related to an additional family of patents to cover methods of treating middle of the night awakenings."
About Transcept
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience. The most advanced Transcept product candidate is Intermezzo(R) (zolpidem tartrate sublingual tablet), for which a New Drug Application (NDA) was submitted to the U.S. Food and Drug Administration (FDA) in September 2008 seeking approval as a prescription sleep aid for use in the middle of the night at the time a patient awakens and has difficulty returning to sleep. In October 2009, Transcept received a Complete Response Letter from the FDA on the Intermezzo(R) NDA and is working to respond to issues raised in the letter. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo(R) in the United States. For further information, please visit the company's website at: www.transcept.com.
CONTACT: Greg Mann, Director, Corporate Communications of Transcept
Pharmaceuticals, Inc., +1-510-215-3567, gmann@transcept.com
Web site: http://www.transcept.com/
