Mei-Shih's Subsidiary Alvogen First to File Generic Version of VYKAT XR for Prader-Willi Syndrome with FDA

Mei-Shih (1795-TW) announced today (24th) that the U.S. FDA has formally accepted the Abbreviated New Drug Application (ANDA) submitted by its subsidiary Alvogen for diazoxide choline (25mg, 75mg, 150mg) extended-release tablets, the generic version of VYKAT XR, making Alvogen the first applicant.

According to the latest Paragraph IV certification list published on the U.S. FDA's official website, Mei-Shih believes Alvogen is the first applicant for the diazoxide choline extended-release tablet. The company submitted its ANDA under the Paragraph IV certification of the Hatch-Waxman Act, asserting that it meets all required conditions.

Mei-Shih stated that upon FDA approval and fulfillment of relevant regulatory requirements, Alvogen is expected to qualify for a 180-day generic drug marketing exclusivity period.

The company explained that the reference drug VYKAT XR is indicated for the treatment of hyperphagia in adult and pediatric patients aged 4 years and older with Prader-Willi syndrome (commonly known as 'Small Fat Willie', PWS). In its first year of launch in 2025, the product generated $190.4 million in revenue. Neurocrine Biosciences acquired Soleno Therapeutics in May 2026 for $2.9 billion. Based on unaudited estimates from the company, VYKAT XR achieved approximately $94 million in revenue during the second quarter of this year, representing a year-over-year increase of 1.87 times.