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- 2015.01
- TWi Confirms Patent Challenge Relating to Oxtellar XR®, Oxcarbazepine ER Tablet
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2015.01.22 TAIPEI, Taiwan- TWi Pharmaceuticals, Inc. ("TWi") confirmed today that it has filed an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) seeking approval to market Oxcarbazepine ER Tablet, a generic version of Oxtellar XR®, which is distributed in the U.S. by Supernus Pharmaceuticals, Inc.
After receiving notice of TWi's ANDA filing, Supernus Pharmaceuticals, Inc. commenced a lawsuit in the U.S. District Court for the District of New Jersey seeking to prevent TWi from commercializing its ANDA product prior to the expiration of Supernus' patents. This lawsuit was initiated under the Hatch-Waxman Act.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.
Contact:
Eric Lin
Investor Relations
Tel: +886-2-2657-3350 ext. 407
email: eric.lin@twipharma.com
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