2017.12
Court Dismisses Patent Challenge to TWi’s Paragraph IV ANDA Filing for a Generic Equivalent to Axiron®

December 13, 2017. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) confirmed today that the district court dismissed the lawsuit filed suit against TWi on February 15, 2017 by Eli Lilly and Acrux DDS Pty Ltd. regarding TWi’s Abbreviated New Drug Application (“ANDA”) seeking US FDA approval to market a generic version of Axiron® (testosterone topical solution). The lawsuit was initiated under the Hatch-Waxman Act. The dismissal of the litigation permits the US FDA to grant final approval of TWi’s generic product as soon as it satisfactorily completes FDA review.

Axiron is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. According to IMS Health data, the total sales of Axiron and its generic products in the US were approximately US$200 million for the 12 months ended December 2016.

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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