Subsidiary Norwich Pharmaceuticals, Inc. Announces Favorable U.S. Federal Court Ruling on Rifaximin Generic Drug Approval Appeal

1. Date of Event: 115/08/26 2. Company Name: Norwich Pharmaceuticals, Inc. 3. Relationship to Company: Subsidiary 4. Cross-shareholding Ratio: 100% 5. Reason for Occurrence: Norwich Pharmaceuticals, Inc., a 100%-owned subsidiary, received today (U.S. Eastern Time, 115/08/25) a ruling from the U.S. Court of Appeals for the District of Columbia Circuit regarding its appeal on the Abbreviated New Drug Application (ANDA) for rifaximin 550mg tablets (reference drug: Xifaxan).

Initially, the FDA granted only a tentative approval for Norwich's rifaximin generic drug, citing that another pharmaceutical company still held 180-day market exclusivity. However, after judicial review, the court ruled that the FDA must reevaluate whether the first applicant's market exclusivity remains valid and whether it continues to block Norwich's final approval. This decision enables the FDA to reexamine the final approval for the rifaximin generic drug.

6. Response Measures: The company will continue preparing regulatory documentation and fully cooperate with subsequent FDA review procedures.

7. Additional Disclosures: The rifaximin 550mg tablet generic drug is primarily used to treat diarrhea-predominant irritable bowel syndrome (IBS-D). According to Bausch Health's 2025 annual report, the reference drug Xifaxan achieved approximately $2.2 billion in U.S. sales over the 12 months ending December 2025.