United Therapeutics Corporation today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Inc. (Sandoz) for infringement of U.S. Patent Nos. 5,153,222, 6,765,117 and 7,999,007 relating to United Therapeutics’ product Remodulin (treprostinil) injection (Remodulin).
The lawsuit is based on an Abbreviated New Drug Application (ANDA) filed by Sandoz with the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of the 10 mg/mL strength of Remodulin. Sandoz’s ANDA alleges that the three patents mentioned above are not valid, not enforceable and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Sandoz’s ANDA submission.
United Therapeutics filed its lawsuit within 45 days of receipt of notice from Sandoz of its ANDA filing. As a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Sandoz’s ANDA for up to 30 months.
United Therapeutics intends to vigorously enforce its intellectual property rights relating to Remodulin, including the three patents mentioned above which are listed in the FDA’s Approved Drug Products List (the Orange Book). However, given the unpredictability inherent in litigation, United Therapeutics cannot predict the outcome of this matter or guarantee the outcome of any litigation.
