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- TWi Settles Patent Challenge Relating to Its Paragraph IV ANDA Filing for a Generic Equivalent to Restasis
January 12, 2017 TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) confirmed today that it has entered an agreement with Allergan, Inc. that settles the lawsuit filed suit against TWi on July 20, 2016 regarding TWi’s Abbreviated New Drug Application (“ANDA”) seeking US FDA approval to market a generic version of Restasis 0.05% cyclosporine ophthalmic emulsion unit dose product. The lawsuit was initiated under the Hatch-Waxman Act. The agreement provides for the dismissal of all litigation related to TWi’s generic version of Restasis. The dismissal of the litigation will permit the US FDA to grant final approval of TWi’s generic product 180 days after the first generic applicant begins commercial marketing of its approved product or sooner if FDA determines that there is no first generic applicant.
About TWi Pharmaceuticals, Inc.
TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high-entry-barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and 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 unparalleled market opportunities in the United States.
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