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Lotus Pharmaceutical Wins Legal Battle Over IBS Drug, Nearing FDA Approval
Health Technology · Pharmaceuticals: Major · cnyes · 2026-08-27
1795
Lotus Pharmaceutical's subsidiary, Norwich, secured a favorable court ruling regarding its Rifaximin generic drug application, clearing a path for potential FDA approval.
What Happened
Legal Victory: Lotus Pharmaceutical (1795-TW) announced that its subsidiary, Norwich, received a favorable ruling from the U.S. Court of Appeals for the D.C. Circuit regarding its ANDA for Rifaximin 550mg tablets. The court determined that the FDA's previous denial of the application was based on flawed criteria regarding market exclusivity, resulting in the case being remanded for further review.
Market Potential: Rifaximin is a generic version of the branded drug Xifaxan, which is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D). According to Bausch Health, Xifaxan generated approximately $2.2 billion in annual sales in the U.S. as of December 2025, highlighting the significant commercial opportunity for the generic version.
Operational Outlook: Following the court's decision, Lotus expects that Norwich will likely receive final FDA approval for its generic Rifaximin in the near future. Successful entry into the U.S. market would represent a significant milestone for the company's growth strategy and its expansion into high-value generic segments.
Market Performance: Despite the positive regulatory news, Lotus shares remained muted during today's trading session. The stock opened higher at NT$198.5 but subsequently pulled back to trade at NT$194, down 0.77% as of 10:00 AM, failing to sustain momentum above the NT$200 psychological threshold.