September 19, 2016. 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 Androgel 1.62%, which the patents are owned by Unimed Pharmaceuticals, LLC, Besins Healthcare Inc., and Besins Healthcare Luxembourg SARL. The owners of the patents filed suit against TWi on September 16th, 2016 (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 July 27th, 2016 for its paragraph IV ANDA submission of generic equivalent to Androgel 1.62%. 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.
Androgel 1.62% 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 Androgel 1.62% in the US were approximately US$1 billion for the 12 months ended December 2015. In addition to the originator, only one ANDA submitted by Perrigo has been approved 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 Androgel 1.62% who have also been sued by patent owners include, but not limited to, Actavis, Amneal, Dr. Reddy’s, Sandoz, and Lupin.
TWi has submitted two ANDAs since the beginning of this year, including the generic equivalent to Restasis for chronic dry eye and the generic equivalent to Androgel for hypogonadism, and both are paragraph IV ANDA filings in the US.
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.
Tel: +886-2-2657-3350 ext. 241