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March 26, 2014
06:18 EDTUTHRUnited Therapeutics announces Japan approval for Remodulin
United Therapeutics announced that Japan's Ministry of Health, Labour and Welfare has granted approval for Remodulin Injection for the treatment of pulmonary arterial hypertension, or PAH, by subcutaneous and intravenous administration. Remodulin will be sold in Japan under the brand name Treprost by Mochida Pharmaceutical, under an exclusive distribution agreement with United Therapeutics.
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September 30, 2015
06:03 EDTUTHRUnited Therapeutics announces settlement of patent litigation with Sandoz
United Therapeutics announced that it has entered into a Settlement Agreement with Sandoz relating to ongoing litigation concerning certain patents relating to United Therapeutics' product, Remodulin Injection, and Sandoz's Abbreviated New Drug Application, or ANDA, seeking approval by the FDA to market a generic version of Remodulin. Under the Settlement Agreement, United Therapeutics granted to Sandoz a non-exclusive license to manufacture and commercialize the generic version of Remodulin described in its ANDA filing in the United States beginning on June 26, 2018, although Sandoz may be permitted to enter the market earlier under certain circumstances. The license included in the Settlement Agreement does not permit Sandoz the right to manufacture a generic version of any other United Therapeutics product, such as Tyvaso Inhalation Solution or Orenitram Extended-Release Tablets, nor does it grant any rights with respect to any technology associated with the Remodulin Implantable System being developed by the Company and Medtronic Inc., or the pre-filled semi-disposable pump system being developed by the Company and DEKA Research & Development Corp. The Settlement Agreement does not grant Sandoz any rights other than those required to launch Sandoz's generic version of Remodulin. In accordance with the Settlement Agreement, the parties will submit the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.

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