United Therapeutics Fires Back After Sandoz Files Anti-Competitive Lawsuit Over PAH Drug

United Therapeutics is taking on accusations that it is unfairly blocking competitors from launching generic versions of the company’s top-selling pulmonary arterial hypertension (PAH) drug, Remodulin.

Sandoz filed a lawsuit that claimed Maryland-based United Therapeutics and Smiths Medical ASD conspired to block the Novartis subsidiary from launching a generic product. After the lawsuit was filed in federal district court in New Jersey, United Therapeutics called the legal claims made “meritless.”

In a statement released earlier this week, United Therapeutics said the lawsuit stems from Sandoz’s own failure to bring its generic version to market, despite having eight years to do so. The lawsuit filed by Sandoz and its development partner RareGen claim that United Therapeutics and Smiths have stymied attempts for its generic of Remodulin (treprostinil) from gaining hold in pharmacies across the country. Less than a month ago, Sandoz launched its generic treprostinil in the United States. In the lawsuit, Sandoz claimed in the lawsuit that United “placed artificial restrictions on Smiths’ cartridges to ensure they can only be used to administer injections of the brand-name treprostinil drug supplied by United Therapeutics.”

The lawsuit alleges that United Therapeutics has instructed pharmacies that dispense Sandoz’s treprostinil that “they are prohibited from purchasing or dispensing Smiths’ cartridges for use with generic treprostinil. And Smiths has committed to sell its entire supply of cartridges to United Therapeutics…” By doing so, Sandoz said United Therapeutics is protecting the drug that drives about 35 percent of its revenue from being challenged by its less-expensive medication.

“Defendants’ anticompetitive conduct has allowed them to control access to treprostinil for subcutaneous injections and enabled them to maintain higher prices for that critical treatment,” Sandoz said in the lawsuit.

PAH is a progressive disease that results in heart failure and shortened life expectancy of the nearly 52,000 PAH patients in the United States.

In its response, United said in 2015 Smiths Medical “publicly announced that it was discontinuing the CADD-MS 3 system,” which is used by many patients to deliver Remodulin. As a result of that announcement, the company said it made a significant investment under an agreement with Smiths Medical that “ensured the CADD-MS 3 system would continue to be available to deliver Remodulin for a period of time.” Without that action, United said many PAH patients would not have been able to access the medication. Additionally, United said it “doubled-down” on its efforts to develop new delivery systems for Remodulin, which generates a significant amount of the company’s annual revenue.

“This lawsuit stems from Sandoz's and RareGen's failure to take similar steps to ensure availability of a system to deliver their product, despite having eight years from filing Sandoz's Abbreviated New Drug Application to do so. Sandoz and RareGen now seek to make us responsible for their failure to properly plan to serve their prospective patients. We expect the litigation to vindicate our efforts to protect our PAH patients,” United said in its response.

The Sandoz lawsuit is not the first time these companies have clashed in court over Remodulin. In 2012, United filed a patent infringement lawsuit against Sandoz. The lawsuit was filed after Sandoz filed an ANDA for its generic drug.