The U.S. generic drug market for Nephoxil, a kidney medication, will face a ban expiration on the 20th of next month. Although this will create competition for Panion & BF Biotech's partner's original drug sales, market analysts expect only a slight decline in U.S. sales for the drug in 2025, given the current trend of bundled payment policies. Panion & BF Biotech is also actively developing new markets, indications, and raw material drug opportunities to drive revenue transformation, hoping to gain customer adoption for raw materials in the U.S. market by 2025 and increase revenue diversification.

The kidney disease medication licensed to Akebia for U.S. sales (marketed as Auryxia) reached a sales peak of over $170 million annually in 2022-2023. Although 2024 sales data is not yet available, market estimates suggest that annual sales will likely be on par with 2023. The major challenge for 2025 is that generic manufacturers will be allowed to enter the market after March 20 under a settlement agreement. However, due to the U.S. insurance system's bundled payment structure for kidney care, the original branded drug will still have a significant advantage during the transition period. The market expects that the U.S. sales decline in 2025 can be controlled to a single-digit percentage, and Panion & BF Biotech is optimistic that strategies such as expanding into other markets and new indications will help maintain royalty income for Nephoxil at the same level as in 2024.

Additionally, Panion & BF Biotech is expanding the new manufacturing process for the raw material iron citrate for Nephoxil. The company has already submitted the U.S. DMF (Drug Master File) and is awaiting customer confirmation for the subsequent review. The company's raw material drug manufacturing plant is also aiming to successfully begin mass production by the end of 2025.

Resource: 腎藥美國新競爭，寶齡富錦仍拚今年授權金持穩