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TSPT > SEC Filings for TSPT > Form 8-K on 13-Sep-2012All Recent SEC Filings

Show all filings for TRANSCEPT PHARMACEUTICALS INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for TRANSCEPT PHARMACEUTICALS INC


13-Sep-2012

Other Events


Item 8.01 Other Events.

On July 11, 2012, Transcept Pharmaceuticals, Inc. ("Transcept") announced that the website of the U.S. Food and Drug Administration ("FDA") indicated that an Abbreviated New Drug Application ("ANDA") for a generic version of Intermezzo® (zolpidem tartrate) sublingual tablet C-IV had been submitted, but that Transcept had not received a Paragraph IV notice letter with respect to this filing. On July 19, 2012, Transcept announced that it had received two Paragraph IV notice letters with respect to Intermezzo. On August 3, 2012, Transcept announced that it had received a third Paragraph IV notice letter with respect to Intermezzo. On August 28, 2012 and September 11, 2012, Transcept announced that it joined actions filed by Purdue Pharmaceutical Products L.P., its U.S. commercialization partner with respect to Intermezzo, in response to such Paragraph IV notice letters.

On September 11, 2012, Transcept received new Paragraph IV notice letters from each of Par Pharmaceutical, Inc. and Par Formulations Private Ltd. (together, "Par") advising Transcept that Par has filed ANDAs with the FDA for generic versions of the 1.75mg and 3.5mg strengths of Intermezzo. These Paragraph IV notice letters allege 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 Par's manufacture, use, importation, sale or offer for sale of the products for which Par's ANDAs were 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 and September 11, 2012. For more information on the risks associated with Transcept's efforts to secure and maintain intellectual property protection for Intermezzo, please see the Risk Factors section of Transcept's Form 10-Q filed with the Securities and Exchange Commission (the "SEC") on August 13, 2012. The information contained herein is intended to be considered in the context of more complete information included in Transcept's filings with the SEC and other public announcements that Transcept has made and may make from time to time by press release or otherwise. Transcept undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosures.


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