Lotus Pharmaceutical Announces Favorable U.S. Appeals Court Ruling on Norwich’s Application for Generic Rifaximin

Taipei, Taiwan and Morristown, N.J., 26 August 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, today announced that Norwich Pharmaceuticals, Inc. (“Norwich”), a wholly owned subsidiary of Alvogen Pharma US Inc. and part of the Lotus group, received a favorable decision in its pending appeal before the U.S. Court of Appeals for the D.C. Circuit concerning its Abbreviated New Drug Application (“ANDA”) for Rifaximin Tablets, 550 mg, a generic version of Xifaxan®, for the treatment of irritable bowel syndrome with diarrhea (“IBS-D”) in adults.

On August 25, 2026, the court ruled that the U.S. Food and Drug Administration (“FDA”) applied an erroneous standard in determining non-forfeiture of another applicant’s 180-day marketing exclusivity when deciding to deny final approval of Norwich’s Rifaximin ANDA.  Consistent with the court’s opinion, we expect the matter to be returned to the FDA for further review.  Lotus anticipates that the FDA will grant final approval to Norwich’s Rifaximin ANDA in the near term.

According to Bausch Health, Xifaxan® generated sales of approximately US$2.2 billion in the United States in 2025¹, a significant portion of which is attributable to the IBS-D indication.

Petar Vazharov, Chief Executive Officer of Lotus, commented: “We are pleased with the court’s decision, which reflects the foresight and strategic judgement of our team in identifying and pursuing high-value, high-barrier opportunities. This represents an important step towards final approval of Norwich’s rifaximin ANDA and reinforces our commitment to expanding access to high-quality, affordable medicines.”

Xifaxan® is a registered trademark of Alfasigma S.p.A.

¹ https://ir.bauschhealth.com/~/media/Files/V/Valeant-IR/reports-and-presentations/2025-annual-report.pdf

This press release contains forward-looking statements.  Forward-looking statements are based on current expectations and are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks include, among others, uncertainties relating to judicial proceedings, including the timing and outcome of any further court action, and regulatory review and decision-making.  Forward-looking statements speak only as of the date of this release. The Company undertakes no obligation to update or revise any forward-looking statements except as required by applicable law.

Founded in 1966, Lotus (1795: TT) is an international pharmaceutical company with a global presence, focused on commercializing both novel and generic pharmaceuticals to provide patients with better, safer, and more accessible medicines. The company boasts a best-in-class R&D and manufacturing platform in Asia, certified by leading regulatory authorities around the world, including the US FDA, EU EMA, Japan PMDA, China FDA, and Brazil ANVISA. Lotus has established partnerships in nearly every major global market, including the U.S., Europe, Japan, China, and Brazil. The company is currently developing and registering over 100 strategically selected pharmaceutical projects across Asia and the U.S., with more than 250 commercial products. Lotus invests in a diversified portfolio, consisting of high-barrier oncology, complex generics, 505(b)2, NCEs, and biosimilars, through both internal R&D investments and licensing-in partnerships to strengthen its portfolio competitiveness.