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- TWi Confirms Patent Challenge Relating to Its Paragraph IV ANDA Filing for a Generic Equivalent to Axiron
February 16, 2017. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) confirmed today that it has filed an Abbreviated New Drug Application (“ANDA”) containing a Paragraph IV certification with US FDA seeking approval to market a generic version of Axiron, which the patents are owned by Acrux DDS PTY LTD. The ANDA holder and the owner of the patents filed suit against TWi on February 15th, 2017 (US time) in the US seeking to prevent TWi from commercializing its ANDA product prior to the expiration of their patents. The lawsuit was initiated under the Hatch-Waxman Act.
TWi officially received the acceptance letter from US FDA on December 30th, 2016 for its paragraph IV ANDA submission of generic equivalent to Axiron. Pursuant to the rules under the Hatch-Waxman Act, the patent owner has the right to file suit within 45 days from the date of being notified by ANDA applicant of the patent challenge. Such a patent litigation is a general practice for a paragraph IV ANDA filing in the US. Given the fact that TWi has not yet launched the product, no indemnification is expected.
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 in the US were approximately US$250 million for the 12 months ended September 2016. In addition to the originator, Two ANDAs submitted by Actavis and Perrigo have been approved in a form of tentative approval by US FDA as of today based on the official website of US FDA. US FDA does not publicly disclose any pending ANDA filings unless approved, and thus we do not have any confirmed details about other pending applications of this product. However, based on the publicly available information and to our best knowledge, other pending filers of Axiron who have also been sued by patent owners include, but not limited to, Amneal, Lupin, Apotex, and Cipla.
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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