Lotus Announces U.S. FDA Approval for First Generic Baloxavir Marboxil Tablets, a Generic Version of Xofluza®

Taipei, Taiwan, and Morristown, N.J., June 29, 2026 - Lotus Pharmaceutical Co., Ltd. (TWSE: 1795, “Lotus” or the “Company”) today announced that Norwich Pharmaceuticals, Inc. (“Norwich”), a wholly owned subsidiary of Alvogen Pharma US Inc. and part of the Lotus group, has received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Baloxavir Marboxil Tablets.

Baloxavir Marboxil Tablets are the first FDA-approved generic version of Xofluza®, a single-dose oral antiviral treatment indicated for the treatment of acute uncomplicated influenza in patients 5 years of age and older who have been symptomatic for no more than 48 hours, and who are otherwise healthy or at high risk of developing influenza-related complications. The product is also indicated for post-exposure prophylaxis of influenza in patients 5 years of age and older following contact with an individual who has influenza. According to Roche, Xofluza® generated sales of approximately CHF57 million in the United States in 2025¹.

Petar Vazharov, Chief Executive Officer of Lotus, commented: “We are pleased to receive approval from the U.S. FDA for Baloxavir Marboxil Tablets. This approval demonstrates the strength of our U.S. platform and our ability to identify, develop and secure first-to-file opportunities in important therapeutic areas. Subject to the terms of a confidential agreement for this product, we remain committed to expanding patient access to high-quality and affordable treatment options.”

Xofluza® is a registered trademark of Genentech, Inc., a member of the Roche Group.

¹  https://www.roche.com/investors/updates/inv-update-2026-01-29

Alvogen is a US-based wholly owned subsidiary of Lotus Pharmaceutical Co., Ltd. focused on developing, in-licensing, manufacturing and marketing pharmaceutical products.  The company has a diverse portfolio and pipeline that includes both branded and generic products across various administration forms. The Alvogen-family of companies includes Alvogen (Generics), Almatica (Brands) and Almaject (Injectables).