Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $134.2 million in 2021 compared to 2020. Unituxin revenues in the fourth quarter of 2021 included $6.3 million related to the launch of Unituxin in Japan. The growth in Unituxin revenues primarily resulted from an increase in quantities sold. The decrease in Remodulin revenues was primarily due to lower quantities sold in the U.S. The growth in Tyvaso revenues resulted primarily from an increase in quantities sold, reflecting an increased number of patients following the expansion of the Tyvaso label to include pulmonary hypertension associated with interstitial lung disease ( PH-ILD). Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $23.5 million in the fourth quarter of 2021 compared to the fourth quarter of 2020. United Therapeutics responded to the agency’s information request however, the FDA has considered this response to be a major amendment to the NDA, extending FDA’s review deadline to May 2022.
Food and Drug Administration ( FDA) requesting additional information regarding the pulmonary safety of Tyvaso DPI related to a pending Citizen's Petition. United Therapeutics recently received an information request letter from the U.S. "Despite a setback with Tyvaso DPI, we remain on track to achieve 6,000 patients with Tyvaso by the end of 2022." "Our commercial teams continue to perform with double-digit percentage growth in revenue and patient counts in 2021 compared to 2020," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics.
David Bennett, Sr., the first UHeart™ recipient, continues to have strong cardiovascular function seven weeks after his transplant." "The recent transplants of our xenoheart and xenokidney products demonstrate the tremendous potential of our business model for the second half of the 2020s and beyond. "We continue to make strong progress with patient growth as we march toward our target of reaching 25,000 patients with our therapies by the end of 2025," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics.