United Therapeutics Corporation

American public benefit corporation specializing in pulmonary hypertension treatments and organ transplant technologies. Reported FY2025 revenue of $3.18 billion.

United Therapeutics was founded in 1996 by Martine Rothblatt, who had previously founded Sirius Satellite Radio (now SiriusXM). After her daughter was diagnosed with PAH, Rothblatt learned that the only available treatment was a prostacyclin called Flolan, which required a continuous intravenous infusion and had a very short shelf life. She founded United Therapeutics to develop a more stable and practical prostacyclin analog.

The company's first product, Remodulin (treprostinil sodium), received FDA approval in 2002 for subcutaneous and intravenous infusion. Remodulin had a longer shelf life than Flolan and could be administered subcutaneously, making it easier for patients to manage. The drug became United Therapeutics' first commercial product and established the company as a leader in PAH treatment.

Tyvaso (treprostinil inhalation) received FDA approval in 2009 for PAH. The inhaled formulation allowed direct delivery of prostacyclin to the lungs, reducing systemic side effects. In 2022, the FDA approved Tyvaso DPI, a dry powder inhaler formulation that eliminated the need for a nebulizer device, significantly improving convenience and patient adherence. Tyvaso DPI has since become the company's primary growth driver.

Orenitram (treprostinil diolamine) received FDA approval in 2013 as an oral prostacyclin tablet. While oral administration is more convenient, Orenitram has faced challenges with absorption and dosing. However, the Medicare Part D benefit redesign under the Inflation Reduction Act, implemented in 2025, improved commercial utilization and drove 14% revenue growth in FY2025.

Unituxin (dinutuximab) was approved by the FDA in 2015 for high-risk neuroblastoma in pediatric patients. The drug was acquired through United Therapeutics' acquisition of the drug's developer. Unituxin is the company's only non-pulmonary hypertension product.

In recent years, United Therapeutics has invested in organ transplant technologies. The company's Lung Bioengineering subsidiary focuses on ex vivo lung perfusion (EVLP) to assess and preserve donor lungs. The company has also pursued xenotransplantation research, including genetically modified pig organs for human transplantation. In 2022, United Therapeutics acquired Miromatrix Medical, a company developing bioengineered organs.

In 2026, the company submitted two NDAs that it described as among the most important in rare pulmonary disease history: ralinepag tablets for PAH and a second NDA for nebulized Tyvaso for a new indication. The ADVANCE OUTCOMES and TETON-1 clinical programs are expected to produce pivotal data that could unlock new treatment options.

As a public benefit corporation, United Therapeutics is legally required to consider the impact of its decisions on all stakeholders, including patients, employees, communities, and the environment. The company's public benefit purpose includes developing treatments for rare diseases and advancing organ transplant technologies.

The company's environmental initiatives include efforts to reduce the carbon footprint of its manufacturing operations and investments in sustainable facilities. United Therapeutics has also pursued LEED certification for its facilities.

The company's organ transplant research, including xenotransplantation and ex vivo lung perfusion, is conducted under FDA oversight and institutional review board approval. The company has published research on its xenotransplantation experiments in peer-reviewed journals.

Drug pricing. As a specialty pharmaceutical company focused on rare diseases, United Therapeutics charges high prices for its products. Tyvaso DPI's list price exceeds $200,000 per patient per year. The company's pricing power is supported by orphan drug exclusivity and patent protection. However, drug pricing has been a political issue in the United States, and the Inflation Reduction Act's Medicare drug price negotiation provisions could eventually affect the company's products.

Patent litigation. United Therapeutics has been involved in patent litigation to protect its treprostinil franchise. The company has sued generic manufacturers seeking to launch generic versions of Remodulin and Tyvaso. These cases have generally been resolved in United Therapeutics' favor, extending market exclusivity.

Xenotransplantation ethics. The company's xenotransplantation research, which involves genetically modifying pigs for organ transplantation, has drawn attention from animal rights groups and bioethicists. The company has conducted experiments transplanting genetically modified pig organs into brain-dead human recipients. While these experiments are conducted under FDA oversight, they raise ethical questions about the use of animals for organ harvesting.

Public benefit corporation status. United Therapeutics' status as a public benefit corporation means it is legally required to consider stakeholders beyond shareholders. This has been generally well-received but creates a unique governance structure that some investors find less transparent than traditional corporations.