All of the drugs based on the treprostinil could potentially see generic competition over the next few years, as a result of patent challenges filed against manufacturer United Therapeutics (UTC).
- The company has already settled lawsuits by agreeing to let several generic drug manufacturers introduce generic versions of Remodulin, the injectable form of the drug. Generic manufacturer Sandoz is expected to be first to market, with an anticipated launch in the second quarter of this year. Other manufacturers — Teva, Par, and Dr. Reddy's — are expected to follow by the end of the year.
- Generic drug manufacturers Watson and Actavis have launched challenges to Tyvaso (the inhaled form) and Orenitram (the oral form).
- An action brought by the manufacturer SteadyMed recently overturned a key patent covering all three drugs. UTC is appealing the decision and maintains that other valid patents still cover the products. Remodulin and Tyvaso are an inhaled and infused drug respectively, and therefore the most expensive PAH drugs currently on market. Generic competition could significantly reduce their cost for payors and patients.