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16 February 2018Americas

United Therapeutics and Actavis shake hands over blood pressure drug

Biotechnology company United Therapeutics has reached a settlement with Actavis Laboratories to resolve a dispute over patents concerning a blood pressure drug.

The settlement was announced on Thursday, February 15.

Orenitram, the drug at the centre of the dispute, is an oral medication containing prostacyclin analogue trepostinil. It is used to treat rare disease pulmonary arterial hypertension by lowering blood pressure.

United Therapeutics owns the drug and it was given approval by the Food and Drug Administration (FDA) in 2013.

Under the agreement United Therapeutics will grant a licence to Actavis, allowing it to manufacture and commercialise a generic version of the product from June 2027.

The dispute began when Actavis submitted an ANDA in an attempt to market the generic version. United Therapeutics responded by filing a patent infringement lawsuit against Actavis, in March 2016.

Meanwhile, pharmaceutical company SteadyMed Therapeutics requested an inter partes review of United Therapeutics’ US patent number 8,497,393, which claims an improved method of producing trepostinil for drugs, including Orenitram. SteadyMed wanted to file for FDA approval of its own trepostinil-based product.

In March 2017 the US Patent Trial and Appeal Board found the claims of the ‘393 patent to be unpatentable. The ‘393 patent was one that United Therapeutics asserted against Actavis in response to its attempt to market generic versions of Orenitram.

In August 2017 United Therapeutics filed a lawsuit against the federal government in the US District Court for the District of California. It claimed its right to exclusively sell Orenitram should continue for a further three years, as a four-year exclusivity period expired that year..

In 2013 the FDA claimed the company had not proven that the formulation of Orenitram is clinically superior to others, according to The Washington Post, and granted the four-year period of exclusivity instead of seven.

United Therapeutics based its claim on the Orphan Drug Act, which gives manufacturers of rare disease drugs a seven-year period to sell drugs without competition. The legislation was brought in to incentivise pharmaceutical companies to develop treatments for rare diseases by providing a period of market monopoly.

According to the settlement release, the parties will submit their settlement agreement to the US Federal Trade Commission and the US Department of Justice, and will also terminate the litigation concerning the patents relating to Actavis’ ANDA for Orenitram.

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