IntelGenx Corp. Receives Buprenorphine/Naloxone Sublingual Film Product Patent Infringement Complaint
Saint Laurent, Quebec--(Newsfile Corp. - August 26, 2013) - IntelGenx Corp. (TSXV: IGX) (OTCQX: IGXT) ("IntelGenx") previously announced the submission to the U.S. Food and Drug Administration ("FDA") of an Abbreviated New Drug Application ("ANDA") filing for approval of a generic formulation of buprenorphine and naloxone Sublingual Film, which had been submitted by Par Pharmaceutical Companies, Inc., our commercialization partner for this product. The reference listed drug is Suboxone® (buprenorphine and naloxone) Sublingual Film. On August 20, 2013, IntelGenx learned that, in response to filing of the ANDA, it was named as a codefendant in a lawsuit pursuant to Paragraph IV litigation filed by Reckitt Benckiser Pharmaceuticals and Monosol RX in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 8,475,832 and 8,017,150, each of which relate to Suboxone®. IntelGenx believes the ANDA product does not infringe those or any other patents, and will vigorously defend itself in this matter. Since Paragraph IV litigation is a regular part of the ANDA process, IntelGenx does not expect any unanticipated impact on our already planned development schedule.
IntelGenx is a drug delivery company focused on the development of oral controlled-release products as well as novel rapidly disintegrating delivery systems. IntelGenx uses its unique multiple layer delivery system to provide zero-order release of active drugs in the gastrointestinal tract. IntelGenx has also developed novel delivery technologies for the rapid delivery of pharmaceutically active substances in the oral cavity based on its experience with rapidly disintegrating films. IntelGenx' development pipeline includes products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, idiopathic pulmonary fibrosis, allergies and pain management. More information is available about the company at www.intelgenx.com.
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