Lotus Pharmaceutical Announces FDA Acceptance of Sole First ANDA Filed for Generic Diazoxide Choline Extended-Release Tablets

Taipei, Taiwan, 24 September 2026 — Lotus Pharmaceutical Co., Ltd. (Taiwan Stock Exchange: 1795), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing an Abbreviated New Drug Application (ANDA) submitted by its subsidiary, Alvogen, Inc., for the 25 mg, 75 mg and 150 mg strengths of diazoxide choline extended-release tablets, the generic version of VYKAT® XR.

Based on the most recent update to the Paragraph IV Certifications List published on the FDA’s website1, Lotus believes that Alvogen, Inc. is the sole first applicant to have submitted a substantially complete ANDA for diazoxide choline extended-release tablets containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Subject to FDA approval and applicable regulatory requirements, Lotus believes that Alvogen will be eligible for 180 days of generic marketing exclusivity.

VYKAT® XR is indicated for the treatment of hyperphagia in adults and paediatric patients four years of age and older with Prader-Willi syndrome. It generated net product revenue of US$190.4 million in 20252, its first year of commercial availability. As reported by Neurocrine Biosciences, Inc., which acquired Soleno Therapeutics in May 2026 for US$2.9 billion3, unaudited pro-forma net product sales of VYKAT® XR for the second quarter of 2026 were US$94 million4, approximately a 187% increase compared to US$33 million in the second quarter of 2025⁵.

Petar Vazharov, Chief Executive Officer of Lotus, commented, “Being the sole first applicant for this product is another major milestone for Lotus, reflecting our team’s ability to identify complex generic opportunities early and execute with speed and discipline. The filing adds to our expanding portfolio of strategically timed ANDA submissions and reinforces our commitment to applying our development and regulatory expertise to expand access to more affordable treatment options for patients.”

VYKAT® XR is a trademark of Soleno Therapeutics, Inc.

 

1 https://www.fda.gov/media/166048/download?attachment

2 https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-reports-fourth-quarter-and-full-year-2025

3 https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-completes-acquisition-soleno-therapeutics

4 https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-reports-second-quarter-2026-financial

5 https://investors.soleno.life/news-releases/news-release-details/soleno-therapeutics-provides-update-us-launch-vykattm-xr-and-0

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 FDA approval and eligibility for generic marketing exclusivity. 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.