Feb 29, 2024

On Rare Disease Day 2024, it’s important to remember the importance of ensuring individuals with rare diseases, such as pulmonary hypertension, have access to innovations that can help them achieve better health outcomes, and that the United States fosters a prescription drug marketplace that encourages and rewards investments in true innovation.

United Therapeutics (UTC), the company that holds a monopoly over the primary medication used to treat pulmonary hypertension, Treprostinil, unfortunately offers a case study in how Big Pharma’s anti-competitive practices and greed block access and undermine market-based incentives to pursue true innovation that benefits patients.

Last week, UTC announced record revenue and expectation-beating earnings for the fourth quarter of 2023.

Martine Rothblatt, chairperson and chief executive officer (CEO) of UTC, kicked off the Big Pharma giant’s earnings call boasting about another record quarter:

“Congratulations to the 1,200 Unitherians who worked tirelessly every day to help us achieve our third straight quarter of record revenue and our second straight year of record revenue. We yet again achieved 20% plus quarterly and annual revenue growth for the fourth quarter and the full year 2023.”

Michael Benkowitz, president, and chief operating officer (COO) of UTC, specifically touted revenue gains from the Tyvaso franchise – the brand name Treprostinil products UTC has shielded from competition with patent thickets and an anti-competitive litigation strategy:

“Importantly, we saw meaningful growth across our entire suite of products, like the Tyvaso franchise, Remodulin in the US, Orenitram and Unituxin. Starting with Orenitram, revenue of $84 million during the quarter was up 11% from the prior year. This growth reflects increases in volume, price and average dose…

Worldwide Remodulin revenue of $115 million for the fourth quarter was down 6% from last year, primarily impacted by International order timing. However U.S. Remodulin revenue of $106 million was up 9%, from the fourth quarter of 2022.

Finally, TYVASO, Worldwide TYVASO revenue was up 45% to $351 million, our highest quarter ever. U.S. revenue was up 40% to $337 million and was the highest quarter ever. U.S. growth in TYVASO was led by the continued uptake of TYVASO DPI. TYVASO nebulizer and TYVASO DPI remain the number one prescribed, prostacyclin treatment in the U.S. and they remain the only approved therapies for PH-ILD.

UTC has had 37 of 49 patent claims invalidated on their Treprostinil products and, in fact, all the patents in the Treprostinil family listed in the Orange Book have been invalidated by either the U.S. District Court or by the Patent Trial and Appeal Board (PTAB). In December, The U.S. Court of Appeals for the Federal Circuit affirmed an earlier decision from the Patent Trial Appeal Board that one of UTC’s Treprostinil patents, ‘793, was invalid.

The same day UTC announced their fourth quarter earnings, the so-called ‘public benefit corporation’ filed a sham lawsuit against their regulator in the latest act of their multi-part strategy to game the system, delay competition and inflict legal costs on would-be competitors to extend the length of their monopoly on the pulmonary hypertension drug

Big Pharma companies continue to profit from egregious anti-competitive tactics that allow them to extend their monopolies, blocking patient access to medicines that could support better health outcomes and undermining would-be competitors from earning a return on investments in true innovation.

To foster a system that incentivizes innovation for patients, including those with rare diseases, lawmakers must crack down on brand name drug companies’ anti-competitive tactics that game the patent system and distort the prescription drug market.

Read PIP’s statement on UTC’s fourth quarter earnings HERE.

Find out more about PIP and our mission HERE.