The suit is based on an ANDA filed by Sandoz seeling approval to market a generic version of the 10mg/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.