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TSPT > SEC Filings for TSPT > Form 8-K on 26-Oct-2012All Recent SEC Filings




Other Events

Item 8.01. Other events.

On September 11, 2012, Transcept Pharmaceuticals, Inc. ("Transcept") received Paragraph IV notice letters from each of Par Pharmaceutical, Inc. and Par Formulations Private Ltd. (together, "Par"), advising Transcept that Par has filed Abbreviated New Drug Applications ("ANDAs") 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. These Paragraph IV notice letters allege that Transcept's U.S. Patent Nos. 7,658,945, 7,682,628, 8,242,131 (the "'131 Patent") and 8,252,809 (the "'809 Patent") 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.

On October 25, 2012, Transcept joined Purdue Pharmaceutical Products L.P. ("Purdue Pharma"), Transcept's U.S. commercialization partner with respect to Intermezzo, and Purdue Pharma L.P. in filing actions against Par (the "Actions") in the U.S. District Court for the District of New Jersey alleging infringement of the '131 and '809 Patents and seeking injunctive and other relief against Par.

The commencement of the Actions automatically stays FDA approval of the Par ANDAs until February 2015 or until an adverse court decision, if any, whichever may occur earlier. Under the Collaboration Agreement between Transcept and Purdue Pharma, Transcept is responsible for 40% of the expense related to Intermezzo patent litigation in the United States. The Transcept share of this expense is subject to an aggregate cap of $1.0 million per calendar year and $4.0 million over the term of the agreement.

For 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 or 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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