United Therapeutics Corporation (NASDAQ: UTHR)said it received notice from a generic drug manufacturer that it intends to release a remanufactured form of one of Silver Spring-based company's core drugs called Remodulin.
Sandoz Inc, submitted a Paragraph IV Certification Notice Letter which United Therapeutics received on February 3, 2012. The letter states that the company has sent an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) also in Silver Spring.
But Sandoz wants to market a generic version of Remodulin before the patents for the drug has expired and has even gone as far as saying the patents are not valid. According to United Therapeutics, Remodulin has three patents with numbers and expirations as follows, U.S. Patent No. 5,153,222, which expires in
Remodulin also known as treprostinil, treats pulmonary arterial hypertension intravenously. The successful drug has been the mainstay product of United Therapeutics bringing in more than half of its sales and helping towards its goal of $1 billion in revenues annually.
United Therapeutics is one of most profitable biotechs in Mid-Atlantic. It is also the largest independent and publicly traded biotech in Maryland and D.C. area measured by market value. The company said it "intends to vigorously enforce its intellectual property rights relating to Remodulin ".
Sandoz, is a subsidiary of pharmaceutical firm Novartis, the company is based in Germany but has U.S. operations in Princeton, NJ.