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- TWi Pharmaceuticals Awarded US$12.7 Million In Generic MEGACE ES® Patent Suit
September 29, 2016. TWi Pharmaceuticals, Inc. (“TWi”) (Stock Ticker: 4180.TT) today announced that the United States District Court for the District of Maryland awarded it US$12.7 million and interest as damages caused by the delay in TWi’s launch of its generic version of Par Pharmaceutical's MEGACE ES® (megestrol acetate oral suspension 625mg/5ml).
Par brought suit against TWi in 2011 alleging infringement of United States Patent No. 7,101,576 (the '576 Patent) and obtained an injunction preventing TWi from launching its generic product when it received final FDA approval in August 2014. The Court later found that the ’576 patent was invalid and the injunction was wrongfully issued. Par’s efforts to overturn the decision were rejected by the United States Court of Appeals for the Federal Circuit.
“We are very pleased to be awarded US$12.7 million to compensate TWi for the delay in the launch of its generic Megace ES,” said Chih-Ming Chen, Ph.D., Chairman and CEO of TWi. “Everyone at TWi worked very hard to bring this product to market and we see this award as a further vindication of our efforts and commitment to bring high-quality affordable pharmaceutical products to patients.”
TWi’s Abbreviated New Drug Application (“ANDA”) for its generic version of MEGACE ES® was approved by US FDA on August 27, 2014. TWi’s product is currently the only approved generic equivalent of MEGACE ES®.
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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